The major objective of this clinical investigation is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE* Bi-Directional Catheter and TRUPULSE* Generator) when used for isolation of the atrial PVs in treatment of subjects with…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety
The primary safety endpoint is the occurrence of Primary Adverse Events (PAEs)
within seven (7) days of the index ablation procedure where the investigational
OMNYPULSE* Bi-Directional Catheter and TRUPULSE* Generator are used per
clinical investigation plan.
PAEs include the following Adverse Events (AEs):
Atrio-Esophageal Fistula*
Phrenic Nerve Paralysis
Cardiac Tamponade/perforation**
Pulmonary Vein Stenosis*
Device or procedure related death*
Stroke/Cerebrovascular Accident (CVA)
Major Vascular Access Complication/Bleeding
Thromboembolism
Myocardial Infarction
Transient Ischemic Attack (TIA)
Pericarditis
Heart Block
Pulmonary Edema (Respiratory Insufficiency)
Vagal Nerve Injury/Gastroparesis
* Device or procedure related death, pulmonary vein stenosis and
atrio-esophageal fistula that occur greater than one week (7 days) and less
than or equal to 90 days post-procedure are considered and analyzed as PAEs.
** Cardiac Tamponade/Perforation occurring up to 30 days post AF ablation
process procedure will be considered a PAE.
Acute Effectiveness
The acute effectiveness endpoint is the electrical isolation of clinically
relevant targeted PVs which is evidenced by confirmation of entrance block
after adenosine/isoproterenol challenge at the end of the index ablation
procedure. Use of a non-study device to achieve PVI is considered an acute
procedural failure.
Secondary outcome
12-month Effectiveness
Freedom from documented (symptomatic and asymptomatic) atrial arrhythmia
(Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of
unknown origin*) episodes based on electrocardiographic data (>=30 seconds on
arrhythmia monitoring device) during the effectiveness evaluation period (day
91-day 365) on or off antiarrhythmic therapy. Acute procedural failure (i.e.,
failure to achieve entrance block with the study device in any of the
clinically relevant targeted PVs) will also be deemed a 12- month effectiveness
failure.
*AFL of unknown origin is defined as all AFL except those CTI dependent AFL as
confirmed by 12-lead electrocardiogram (ECG) or entrainment maneuvers in an EP
study.
Background summary
The Biosense Webster Pulsed Field (PF) Ablation System consists of the:
- TRUPULSE* Generator (D-1417-01-IC)
- OMNYPULSE* Bi-Directional Catheter (D-1430-05-SI)
- Sterile Interface Cable (D-1422-03-SI)
- Related components and accessories
The Biosense Webster PF Ablation System provides a novel solution for the
treatment of cardiac arrythmias through pulsed field ablation (PFA). The PFA
technology ablates targeted cardiac tissue by application of ultrashort
electrical pulses, pulsed field (PF) energy, which induces cell membrane
permeability resulting in irreversible electroporation (IRE).
The principal components of the PF ablation system to be evaluated in this
investigation are:
• The OMNYPULSE* Bi-Directional Catheter (used for cardiac electrophysiological
mapping, stimulating and recording, and cardiac ablation when used with the
Biosense Webster TRUPULSE* Generator).
The catheter will be used in conjunction with the investigational accessory
devices: the Sterile Interface Cable and the Guiding Sheath.
• The TRUPULSE* Generator (delivers PF energy when used with the OMNYPULSE*
Bi-Directional Catheter).
Both devices are compatible with the Biosense Webster CARTO* 3 System.
Study objective
The major objective of this clinical investigation is to demonstrate safety and
effectiveness of the ablation system (OMNYPULSE* Bi-Directional Catheter and
TRUPULSE* Generator) when used for isolation of the atrial PVs in treatment of
subjects with PAF.
Acute safety and acute effectiveness will be evaluated through hypothesized
primary endpoints and 12-month effectiveness will be evaluated through a
hypothesized secondary endpoint.
The additional objectives of this clinical investigation are to evaluate
procedural data, quality of life and the incidence of (procedure and/or device
related) serious adverse events during and after index ablation procedure up to
12 months
Study design
Prospective, single arm, multi-center, pre-market clinical evaluation of the PF
ablation system (OMNYPULSE* Bi-Directional Catheter and TRUPULSE* Generator) to
demonstrate safety and effectiveness for the treatment of Paroxysmal Atrial
Fibrillation (PAF) comparing to corresponding performance goals.
To minimize any learning curve effect, the first 2 study subjects treated by
each ablating physician, will be considered roll-in subjects.
The main study will enroll 135 evaluable subjects with PAF who are candidates
for atrial fibrillation ablation. Embedded within the main study will be a
Neurological Assessment (NA) subset, a Cardiac Computed Tomography (CT) or
Magnetic Resonance Angiogram (MRA) image subset, an Esophageal Endoscopy (EE)
subset and a Pulmonary Vein Isolation (PVI) durability subset in a prospective
manner. These subsets are intended to delineate safety and assess lesion
durability at 2-3 months following ablation. Thirty patients participating to
the main study will be included in the subset study. The same subjects will
participate in all four (4) subsets. Participation to the substudy is
voluntary. If a study participant does not wants to participate to the
substudy, this will not influence his/her further care.
All subjects will be followed for 12 months and scheduled for evaluation at 7
days, 1-, 3-, 6- and 12-month following index ablation procedure.
Intervention
Subjects will arrive at the electrophysiology (EP) laboratory for their
ablation procedure and will undergo preparation for the procedure per the
hospital*s standard protocol (discretion of investigator).
The AF ablation procedure will follow below sequence:
1. Anatomical mapping of the Left Atrium (LA).
2. Pulmonary Vein (PV) Isolation with PF energy using the study catheter and
generator.
3. Confirmation of PV Isolation (entrance block) with adenosine/isoproterenol
challenge.
4. If necessary, treatment of acute reconnections with additional applications
of PF energy.
5. Confirmation of entrance block of all targeted PVs at the end of procedure.
All subjects will undergo PV ablation with the investigational device until PVI
is achieved and confirmed via entrance block. If PVI cannot be achieved with
the investigational device, a commercially approved Biosense Webster (RF)
catheter and compatible commercially available RF generator can be used to
complete the procedure.
A right atrial Cavotricuspid Isthmus (CTI) linear ablation is allowed only in
cases with documented typical atrial flutter (AFL) either prior to or during
the index ablation procedure. The CTI line should be completed with a
commercially approved and compatible Biosense Webster (RF) catheter and (RF)
generator.
Study burden and risks
Pre-Procedure/Baseline Visit Assessments:
- Read and signature on Patient Information and Consent
- Collection of Patients Demographics, Medical History and Anticoagulation
Therapy information
- Collection of Pregnancy test for all women of childbearing age and potential.
- Imaging (TTE or other acceptable equivalent cardiac imaging) to assess the
left atria and left ventricular ejection fraction (assessment only to be
performed if this information is not available within 6 months prior to the
procedure).
- Imaging for detection of left atrial thrombus or other structural
contraindications to an ablation procedure.
- Imaging Cardiac CT/MRA to assess the structure and size of the Pulmonary
Veins and anatomy of the left atrium.
- Record a 12-Lead ECG
- Collect Patient Questionnaire - Atrial Fibrillation Effect on Quality of Life.
This visit may take a little bit longer then routine care for the patient, as a
questionnaire and consent need to be explained and completed, but will not
cause any additional burden or risk compared to routing case.
Cardiac Ablation Procedure:
No additional burden and risk to the patients as in a routine care ablation
procedure.
Pre-discharge Visit Assessments:
- Collection of Medication Regimen information.
- Imaging of Pericardial fluid presence (safety check).
- Collection of Adverse Events information
- Record of 12-Lead ECG (as per standard of care).
This visit has no additional burden and risk to the patients.
Assessments at 7 Days follow-up (via clinical visit or via telephone call)
visit assessments:
- Collection of Medication Regimen information.
- Collection of Adverse Events information
This visit has no additional burden or risk to the patients, as the visit can
be conducted per telephone call and might take up to 15 minutes.
The 1, 3, 6 and 12-months follow-up visit assessments in the Main Study are:
- Collection of Medication Regimen information.
- Collection of Adverse Events information
- Record of 12-Lead ECG
- Remote Monitoring (on Weekly and Monthly base)
- 24 Hour Holter Monitoring.
These visits have some additional burden to the patients but not additional
risks compared with their routine care. In addition the follow-up of the
medical health of the patient is more ensured with this tight follow-up scheme.
Patients who will participate in the subset study will have more additional
burden and risks, compared with the patients participating only in the Main
subject, because these subset patients will have additional Cerebral MRI,
Neurological Exam and Neurological Evaluation (using questionnaires)
assessments at baseline, discharge, 1, 3, 6 and 12-months follow-up visit.
Refer to the protocol synopsis table 1 for a schematic overview.
Leonardo Da Vincilaan 15
Diegem 1831
NL
Leonardo Da Vincilaan 15
Diegem 1831
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosed with Symptomatic Paroxysmal AF defined as AF that terminates
spontaneously or with intervention within 7 days of onset. This PAF is
considered to be symptomatic if symptoms related to AF are experienced by the
patient.
2. Selected for AF ablation procedure by pulmonary vein isolation (PVI).
3. Age 18-75 years.
4. Willing and capable of providing consent.
5. Able and willing to comply with all pre-, post- and follow-up testing and
requirements.
Exclusion criteria
1. Previously known AF secondary to electrolyte imbalance, thyroid disease, or
reversible or non-cardiac cause (e.g., documented obstructive sleep apnea,
acute alcohol toxicity, morbid obesity (Body Mass Index >40 kg/m²), renal
insufficiency (with an estimated creatinine clearance < 30 mL/min/1.73 m2) *.).
2. Previous LA ablation or surgery. 3. Patients known to require ablation
outside the PV region (e.g., atrioventricular reentrant tachycardia,
atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular
tachycardia and Wolff-Parkinson-White). 4. Previously diagnosed with persistent
AF (> 7 days in duration). 5. Severe dilatation of the LA (LAD >50mm
antero-posterior diameter in case of Transthoracic Echocardiography (TTE)). 6.
Presence of LA thrombus. 7. Severely compromised Left Ventricular Ejection
Fraction (LVEF <40%). 8. Uncontrolled heart failure or New York Heart
Association (NYHA) Class III or IV. 9. History of blood clotting, bleeding
abnormalities or contraindication to anticoagulation (heparin, warfarin, or
dabigatran). 10. History of a documented thromboembolic event (including TIA)
within the past 6 months. 11. Previous Percutaneous Coronary Intervention (PCI)
/ Myocardial Infarction (MI) within the past 2 months. 12. Previous Coronary
Artery Bypass Grafting (CABG) in conjunction with valvular surgery, cardiac
surgery (e.g., ventriculotomy, atriotomy) or valvular cardiac (surgical or
percutaneous) procedure. 13. Unstable angina pectoris within the past 6 months.
14. Anticipated cardiac transplantation, cardiac surgery, or other major
surgery within the next 12 months. 15. Significant 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. 16. Known significant PV anomaly that in
the opinion of the investigator would preclude enrollment in this study. 17.
Prior diagnosis of pulmonary vein stenosis. 18. Pre-existing hemi diaphragmatic
paralysis. 19. Acute illness, active systemic infection, or sepsis. 20.
Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch
or other abnormality that precludes catheter introduction or manipulation. 21.
Severe mitral regurgitation. 22. Presence of implanted pacemaker or Implantable
Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that
may interfere with the pulsed electric field energy. 23. Presence of a
condition that precludes vascular access (such as Inferior Vena Cava (IVC)
filter) 24. Significant congenital anomaly or a medical problem that in the
opinion of the investigator would preclude enrollment in this study. 25.
Categorized as vulnerable population and requires special treatment with
respect to safeguards of well-being. 26. Current enrollment in an
investigational study evaluating another device or drug. 27. Women who are
pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who
are of child-bearing age and plan on becoming pregnant during the course of the
clinical investigation. 28. Life expectancy less than 12 months. 29. Presenting
contra-indications for the devices used in the study, as indicated in the
respective Instructions For Use (IFU). Additional exclusion criteria for
Neurological Assessment (NA) subjects: 30. Known contraindication for MRI such
as use of contrast agents due to advanced renal disease, claustrophobia etc.
(at PI discretion). 31. Presence of iron-containing metal fragments in the
body. 32. Known unresolved pre-existing neurological deficit. Additional
exclusion criteria for Esophageal Endoscopy (EE) subjects: 33. Known
uncontrolled significant GastroEsophageal Reflux Disease (GERD)
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 |
|---|---|
| Other | CIV-23-06-043176 |
| CCMO | NL84145.000.23 |