The VOLT CE Mark study will collect data to demonstrate that the Volt PFA System is functioning as intended in a clinical setting and to demonstrate acute safety and effectiveness for the treatment of symptomatic, recurrent paroxysmal atrial…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Safety will be summarized as the rate of subjects experiencing a device
and/or procedure-related serious adverse event with onset within 7-days of any
ablation procedure (index or repeat procedure) that uses the Volt PFA System
that are defined below:
• Atrio-esophageal fistula1
• Cardiac tamponade/perforation2
• Death
• Heart block
• Myocardial infarction
• Pericarditis3
• Phrenic nerve injury resulting in permanent diaphragmatic paralysis
• Pulmonary edema
• Pulmonary vein stenosis1
• Stroke/cerebrovascular accident
• Thromboembolism
• Transient ischemic attack
• Vagal nerve injury/gastroparesis
• Major vascular access complications4 / major bleeding events5
• Device and/or procedure related cardiovascular and/or pulmonary adverse event
that prolongs hospitalization for more than 48 hours (excluding hospitalization
solely for arrhythmia recurrence or non-urgent cardioversion)
2. Acute Effectiveness
Acute procedural effectiveness will be summarized as the rate of pulmonary
veins treated with the Volt PFA system that are isolated at the end of the
index ablation procedure. Acute procedural failure for each pulmonary vein is
defined as any of the following:
1. Inability to isolate a pulmonary vein at the end of the index ablation
procedure or after maximum allowed therapy applications. Isolation will be
assessed via confirmation of electrical isolation in each targeted pulmonary
vein after a minimum waiting period of 20 minutes via entrance block at a
minimum. Touch-up ablation to achieve isolation will be allowed for any
pulmonary vein reconnection detected during the index procedure with the
investigational catheter (to the maximum delivery allowed per vein) and will
not be considered a failure.
2. Any use of a non-study ablation device for pulmonary vein isolation.
Long term effectiveness
Long-term 6-month effectiveness will be summarized as the rate of freedom from
documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds
duration that are documented by protocol-specified 12-lead ECG,
trans-telephonic monitoring (TTM) or Holter monitor after the index ablation
procedure through 6 months of follow-up (after a 90-day blanking period
following the index ablation procedure).
Secondary outcome
Additional data
1. 12- Month Long-term effectiveness: Freedom from documented (symptomatic or
asymptomatic) AF/AFL/AT episodes of >30 seconds duration that are documented by
protocol-specified 12-lead ECG, transtelephonic monitoring (TTM) or Holter
monitor after the index ablation procedure through 12 months of follow-up
(after a 90-day blanking period following the index ablation procedure),
utilizing the long-term effectiveness endpoint failures defined above.
2. Rate of subjects with procedural success of PVI ablation with the Volt PFA
System defined as in Section 4.1.2 in the PFAD population and in the Per
Protocol population (defined in Section 8.1), where inability to isolate any
pulmonary vein would constitute a failure.
3. Proportion of subjects with successful first-pass isolation of all targeted
veins, and proportion of all targeted pulmonary veins with successful
first-pass PV isolation, where first pass isolation is defined as confirmation
of entrance block in the ablated pulmonary vein following the initial minimum
waiting period of 20 minutes without any ablation after the start of the
20-minute waiting period.
4. Proportion of subjects that experience any procedure and/or Volt PFA
System-related adverse event (AE) throughout the 12-month follow-up period.
5. 6-month and 12-month single procedure effectiveness, defined as 6-month or
12-month effectiveness as above after a single ablation procedure. Any repeat
ablation procedure required by the subject at any time will be deemed a failure.
6. Proportion of subjects requiring one or more repeat AF ablations at 12
months following the index AF ablation procedure. Of those subjects with repeat
ablations, the proportion of treated pulmonary veins ablated with
reconnections, and locations of pulmonary vein reconnections (of treated veins)
upon electro-anatomical remapping.
7. Changes in EQ-5D-5L and AFEQT scores from baseline to follow up at 3, 6, and
12-months after the index procedure.
8. Procedure data, including but not limited to ablation data, mapping data,
usage of Automark, usage of the LivePoint, method(s) used for catheter
placement (e.g., fluoroscopy, intracardiac ultrasound, etc.), procedure time,
fluoroscopy time, total ablation time, LA dwell time, time to perform PVI, and
number and location of PFA energy applications.
9. Cardiovascular-related health care utilization through 12-months after the
index procedure, including but not limited to, cardiovascular or AF-related
hospitalization (includes readmission) or emergency visit, cardioversion,
repeat ablations, use of AADs after 3-month blanking period, and primary SAEs.
10. Arrhythmia monitoring (12-lead ECG, HM, and TTM) compliance
11. Change in PV diameter from baseline to 3 months post procedure.
12. Incidence, number, size (diameter and volume) and anatomic location of
cerebral lesions detected on post-procedure brain MRI compared to pre-procedure
brain MRI.
Background summary
AF is associated with mortality and comorbidities such as stroke, heart failure
and sudden cardiac death. In a meta-analysis of contemporary, well-controlled,
randomized clinical trials in AF, the mean annual stroke rate was 1.5% and the
annualized mortality rate was 3% in AF patients on anticoagulants.6 A minority
of these deaths are stroke-related , while sudden cardiac death and death from
progressive heart failure are more common, highlighting the need for
interventions beyond anticoagulation.7, 8 Atrial fibrillation is also
associated with high hospitalization rates. This hospitalization is usually for
AF treatment, but is also often due to heart failure, myocardial infarction,
and treatment-related complications. 9, 10 In addition, patients with AF have a
significantly worse quality of life than healthy controls, and experience a
variety of symptoms, including lethargy, palpitations, shortness of breath,
chest pain, sleep problems and mental problems. The current conventional
approach to perform catheter ablation is via thermal energy such as
cryoablation or radiofrequency (RF) energy to achieve pulmonary vein isolation
(PVI). However, there are many limitations to current standard care ablation
technologies, and even when PVI is performed in highly experienced centers,
recurrences are observed in approximately 20% of patients [ref]. In addition,
the reliance of these technologies on conductive heating and cooling carries
risks to organs or tissues adjacent to the heart, which can lead to side
effects such as atrial esophageal fistula, pulmonary vein stenosis, phrenic
nerve palsy, among others [ref ].
Irreversible electroporation (IRE) is a mechanism for inducing cell death
through the application of pulsed electric fields (PEF). Pulsed field ablation
(PFA) uses IRE to selectively destabilize cell membranes to initiate cell
death, resulting in a non-thermal ablation lesion. Interestingly, myocardial
tissue has a lower voltage threshold susceptible to PFA compared to surrounding
tissues such as the esophagus, blood vessels and nerve fibers [ref], reducing
the risk of damage to these non-cardiac tissues and potentially lowering the
number of associated side effects . events. In a review of the current
literature, studies/surveys such as the IMPULSE/PEFCAT/PEFCAT II, **PersAFOne,
PULSED AF, 5S, and MANIFEST-PF have shown that PFA catheters are as safe or
safer than other ablation strategies.16-21 In addition, none of clinical trials
reviewed found PFA catheters to be less safe than current standard ablation
catheters. Each PFA device currently in preclinical or clinical research is
unique in terms of electrode design, pulse length, number of pulses, and
voltage. These parameters are critical in developing optimal PFA energy
delivery for safe and sustainable lesions.
To date, all studies have demonstrated high acute efficacy in achieving PVI and
a low rate of recurrent atrial arrhythmias. With the increasing healthcare
burden of AF and the continued need for greater safety and effectiveness in
treatments, the Volt* PFA System was developed to deliver high voltage therapy
for the safe and effective treatment of symptomatic recurrent AF.
referenties:
6. Kirchhof P, Breithardt G, Camm AJ, Crijns HJ, Kuck KH, Vardas P and
Wegscheider K. Improving outcomes in patients with atrial fibrillation:
rationale and design of the Early treatment of Atrial fibrillation for Stroke
prevention Trial. Am Heart J. 2013;166:442-8.
7. Marijon E, Le Heuzey JY, Connolly S, Yang S, Pogue J, Brueckmann M,
Eikelboom J, Themeles E, Ezekowitz M, Wallentin L, Yusuf S and Investigators
R-L. Causes of death and influencing factors in patients with atrial
fibrillation: a competing-risk analysis from the randomized evaluation of
long-term anticoagulant therapy study. Circulation. 2013;128:2192-201.
8. Senoo K, Lip GY, Lane DA, Buller HR and Kotecha D. Residual Risk of Stroke
and Death in Anticoagulated Patients According to the Type of Atrial
Fibrillation: AMADEUS Trial. Stroke. 2015;46:2523-8.
9. Steinberg BA, Kim S, Fonarow GC, Thomas L, Ansell J, Kowey PR, Mahaffey KW,
Gersh BJ, Hylek E, Naccarelli G, Go AS, Reiffel J, Chang P, Peterson ED and
Piccini JP. Drivers of hospitalization for patients with atrial fibrillation:
Results from the Outcomes Registry for Better Informed Treatment of Atrial
Fibrillation (ORBIT-AF). Am Heart J. 2014;167:735-42 e2.
10. Thrall G, Lane D, Carroll D and Lip GY. Quality of life in patients with
atrial fibrillation: a systematic review. Am J Med. 2006;119:448 e1-19.
16. Reddy VY, Anic A, Koruth J, Petru J, Funasako M, Minami K, Breskovic T,
Sikiric I, Dukkipati SR, Kawamura I and Neuzil P. Pulsed Field Ablation in
Patients With Persistent Atrial Fibrillation. Journal of the American College
of Cardiology. 2020;76:1068-1080.
17. Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H,
Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J and Jais P.
Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of
IMPULSE, PEFCAT, and PEFCAT II. JACC: Clinical Electrophysiology.
2021;7:614-627.
18. Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L,
Chovanec M, Dukkipati SR and Jais P. Pulsed Field Ablation for Pulmonary Vein
Isolation in Atrial Fibrillation. Journal of the American College of
Cardiology. 2019;74:315-326.
19. Verma A, Boersma L, Haines DE, Natale A, Marchlinski FE, Sanders P, Calkins
H, Packer DL, Hummel J, Onal B, Rosen S, Kuck K-H, Hindricks G and Wilsmore B.
First-in-Human Experience and Acute Procedural Outcomes Using a Novel Pulsed
Field Ablation System: The PULSED AF Pilot Trial. Circulation: Arrhythmia and
Electrophysiology. 2022;15.
20. Ekanem E, Reddy VY, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J,
Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T,
Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D,
Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Futing A, Rillig A,
Mulder BA, Johannessen A, Rollin A, Lehrmann H, Sohns C, Jurisic Z, Savoure A,
Combes S, Nentwich K, Gunawardene M, Ouss A, Kirstein B, Manninger M, Bohnen
JE, Sultan A, Peichl P, Koopman P, Derval N, Turagam MK, Neuzil P and
Cooperative M-P. Multi-national survey on the methods, efficacy, and safety on
the post-approval clinical use of pulsed field ablation (MANIFEST-PF).
Europace. 2022.
21. Schmidt B, Bordignon S, Tohoku S, Chen S, Bologna F, Urbanek L, Pansera F,
Ernst M and Chun KRJ. 5S Study: Safe and Simple Single Shot Pulmonary Vein
Isolation With Pulsed Field Ablation Using Sedation. Circ Arrhythm
Electrophysiol. 2022;15:e010817.
Study objective
The VOLT CE Mark study will collect data to demonstrate that the Volt PFA
System is functioning as intended in a clinical setting and to demonstrate
acute safety and effectiveness for the treatment of symptomatic, recurrent
paroxysmal atrial fibrillation (PAF) and persistent atrial fibrillation
(PersAF).
Study design
Pre Market, prospective, single arm, non-randomized study with a substudy of
the first 30 subjects in who additional diagnostic test will be done.
Intervention
Pulsed Field Ablation therapy using Volt PFA System
Study burden and risks
Extensive risk analysis and mitigation plans will be implemented to mitigate
any residual risk from the Volt* PFA
catheter, Sensor Enabled*, along with the Volt* PFA Generator, Agilis* NxT
Steerable Introducer Dual-Reach*, and EnSite* X EP System for subjects. The
risks associated with Abbott's Volt PFA System are expected to be similar to
those associated with the use of other commercially available ablation
catheters approved for the treatment of symptomatic recurrent PAF and PersAF.
The patients participating in this study are indicated for cardiac ablation for
the treatment of symptomatic recurrent PAF or PersAF as part of their standard
medical care and are subject to the risks associated with these devices.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. Documented symptomatic PAF or PersAF. Documentation requirements are as
follows: Paroxysmal:
• Physician's note indicating recurrent self-terminating AF AND
• One electrocardiographically documented PAF episodes within 12 months.
Documented evidence of the PAF episode must either be continuous AF on a
12-lead ECG or include at least 30 seconds of AF from another ECG device.
Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is
documented by
• Physician's note, AND either
• 24-hour Holter within 180-days prior to the procedure, showing continuous AF,
OR
• Two electrocardiograms (from any form of rhythm monitoring) showing
continuous AF:
o that are taken at least 7 days apart but less than 12 months apart
o If electrograms are more than 12 months apart, there must be one or more
Sinus Rhythm recordings in between or within 12 months prior to
consent/enrollment
with the most recent electrocardiogram within 180 days of enrollment.
Documented evidence of the AF episode
must either be continuous AF on a 12-lead ECG or include at least 30 seconds of
AF from another ECG device
2. Plans to undergo a PVI catheter ablation procedure due to symptomatic PAF or
PersAF that is refractory or intolerant to at least one Class I or Ill
antiarrhythmic drug
3. At least 18 years of age
4. Able and willing to comply with all trial requirements including
pre-procedure, post- procedure, and follow-up testing and requirements
5. Informed of the nature of the trial, agreed to its provisions, and has
provided written informed consent as approved by the Institutional Review
Board/Ethics Committee (IRB/EC) of the respective clinical trial site.
Exclusion criteria
1. Previously diagnosed long-standing persistent atrial fibrillation
(Continuous AF greater than 1 year in duration) 2. Arrhythmia due to reversible
causes including thyroid disorders, acute alcohol intoxication, electrolyte
imbalance, severe untreated sleep apnea, and other major surgical procedures in
the preceding 90 days
3. Participant known to require ablation beyond PVI at the time of consent
4. Known presence of cardiac thrombus
5. Left atrial diameter 5.5 cm (anteroposterior diameter) within 180 days of
index procedure
6. Left ventricular ejection fraction < 35% as assessed with echocardiography
within 180 days of index procedure 7. New York Heart Association (NYHA) class
Ill or IV heart failure 8. Body mass index > 40 kg/m2 9. Pregnant, nursing, or
planning to become pregnant during the clinical investigation follow-up period
10. Patients who have had a ventriculotomy or atriotomy within the preceding 30
days of procedure, 11. Myocardial infarction (Ml), acute coronary syndrome,
percutaneous coronary intervention (PCI), or valve or coronary bypass grafting
surgery within preceding 90 days
12. Unstable angina
13. Stroke or TIA (transient ischemic attack) within the last 90 days
14. Heart disease in which corrective surgery is anticipated within 180 days
after procedure
15. History of blood clotting or bleeding abnormalities including
thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected
anti-coagulant state
16. Contraindication to long term anti-thromboembolic therapy
17. Patient unable to receive heparin or an acceptable alternative to achieve
adequate anticoagulation
18. Known sensitivity to contrast media (if needed during the procedure) that
cannot be controlled with pre-medication
19. Previous left atrial surgical or left atrial catheter ablation procedure
(including LAA closure device)
20. Presence of any condition that precludes appropriate vascular access
21. Severe mitral regurgitation (regurgitant volume 60 ml/beat, regurgitant
fraction 50%, and/or effective regurgitant orifice area 0.40cm2).
22. Previous tricuspid or mitral valve replacement or repair
23. Patients with prosthetic valves
24. Patients with a myxoma
25. Patients with an interatrial baffle or patch as the transseptal puncture
could persist and produce an iatrogenic atrial shunt
26. Stent, constriction, or stenosis in a pulmonary vein
27. Rheumatic heart disease
28. Hypertrophic cardiomyopathy
29. Diagnosed with amyloidosis or atrial amyloidosis
30. Active systemic infection
31. Renal failure requiring dialysis
32. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive
or chronic obstructive pulmonary disease) or any other disease or malfunction
of the lungs or respiratory system that produces severe chronic symptoms
33. Presence of an implantable therapeutic cardiac device including permanent
pacemaker, biventricular pacemaker, or any type of implantable cardiac
defibrillator (with or without biventricular pacing function) or planned
implant of such a device for any time during the follow up period. Presence of
an implantable loop recorder is acceptable as long as it is removed prior to
insertion of the investigational device.
34. Presence of an implanted LAA closure device or plans to have an LAA closure
device implanted during the follow-up period
35. Patient is currently participating in another clinical trial or has
participated in a clinical trial within 30 days prior to screening that may
interfere with this clinical trial without pre-approval from this study Sponsor
36. Unlikely to survive the protocol follow up period of 12 months
37. Presence of other medical, anatomic, comorbid, social, or psychological
conditions that, in the investigator's opinion, could limit the subject's
ability to participate in the clinical investigation or to comply with
follow-up requirements, or impact the scientific soundness of the clinical
investigation results.
38. Individuals without legal authority
39. Individuals unable to read or write
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06106594 |
| CCMO | NL85151.000.23 |