The objective of this study is to evaluate the reliability of the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap® Software) to identify AF sources and guide ablation therapy in patients with persistent atrial fibrillation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint events for this trial to assess the safety and
effectiveness of the Ablamap® Software System to guide therapy for the
treatment of persistent atrial fibrillation are as follows:
• Primary Safety Endpoint: Freedom from serious adverse events (SAEs) related
to the procedure through 7 days following the randomization procedure.
• Primary Effectiveness Endpoint: Acute procedure success defined as the
ability to successfully ablate AF sources identified by the EGF algorithm.
Secondary outcome
The following safety and efficacy secondary endpoints will be evaluated to
support the results of the primary endpoints:
• Secondary Safety Endpoint: Freedom from serious adverse events (SAEs)
related to the procedure through 12 months following the randomization
procedure.
• Secondary Efficacy Endpoints:
o Consistency of sources identified by the Ablacon® EGF algorithm between the
randomization procedure and any subsequent EGF-guided ablation procedures
o Freedom from documented episodes of AF recurrence following the blanking
period (90 days post ablation) through 12 months
o Total number of EGF source ablations
o Total time of EGF source ablations
o Total fluoroscopy time and dose
o Overall procedure time
Background summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is
associated with increased mortality, morbidity and impaired quality of life.
Catheter ablation has become the standard of care for symptomatic patients with
drug-refractory AF and the cornerstone of ablation is the electrical isolation
of the pulmonary veins (pulmonary vein isolation = PVI).1 Long-term
effectiveness of an approach based on PVI as the sole ablation strategy is
reported to be high for patients with paroxysmal AF (81.6% at 12 months, 73.8%
at 24 months, and 68.1% at 36 months.2 However, the success rate of PVI is
significantly lower with only up to 51% in patients with persistent AF.3 It is
assumed that this is due to the fact that persistent AF is often driven by
focal and reentrant activity in the atrial substrate rather than in the
pulmonary veins.4 Accurate, enhanced mapping techniques that can localize those
extra PV sources are essential to identify and guide ablation of these sources
independently from PVI.
Narayan, et al., used a 64 pole-basket catheter to map AF using unipolar
electrograms recorded in the right and the left atrium to construct
spatiotemporal source maps.5 The technology was called Focal Impulse and Rotor
Modulation (FIRM). Compared with patients undergoing conventional AF ablation,
FIRM guided ablation initially seemed to be associated with a higher acute
success and a better outcome as demonstrated in non-randomized studies.
However, in randomized multi-center studies, significant benefit of FIRM guided
ablation was not confirmed.6
Since Narayan*s pioneer work several other systems were developed to invasively
map rotational activities: Biosense Webster Carto Finder uses phase mapping
applied to 64-pole basket catheter unipolar electrograms to identify rotors in
the atrial wall.7 Acutus medical uses dipole density mapping with a 48-pole
non-contact basket catheter to identify sources of excitation; CardioNXT uses
small spiral catheters to search for AF-sources based on typical source pattern
cross-correlation with coronary sinus catheter signals; Volta Medical detects
dispersion of activation maps in bipolar electrogram signals recorded using the
PentaRay catheter with five splines and 20 poles.8,9,10 However, none of these
newer mapping systems have demonstrated the clinical relevance of these
extra-pulmonary vein sources of excitation in the atrial myocardium over a
period longer than a few seconds. As such, the ability to identify and ablate
relevant non-pulmonary vein foci/triggers to improve freedom from AF
post-ablation has not been achieved to date.
The recently developed Electrographic Flow (EGF) Mapping system (Ablamap®
Software, Ablacon, Wheat Ridge, CO) is a technology based on a novel algorithm
being able to (1) discriminate between active sources of excitation and passive
rotations which do not generate action potentials and (2) estimate the average
activity of such a source during a time interval such as one minute.11 It has
been shown that only those sources that are generating excitation and that are
active more than a quarter of the time are significant predictors for AF
recurrence after PVI.12 The EGF system uses a velocity vector matrix created
through an optical flow analysis applied on surface voltage movies created
using a minimal energy algorithm from endocardial unipolar electrograms. The
analysis is conducted with the 64-electrode mapping basket catheter, which was
also used for FIRM-guided rotor mapping.
The goal of this clinical trial is to evaluate this novel mapping software for
identifying AF sources in humans with persistent AF to optimize ablation
success in this challenging and heterogeneous patient population. To date no
EGF-guided ablation of AF sources has been performed in a controlled trial.
Study objective
The objective of this study is to evaluate the reliability of the Ablacon
Electrographic Flow (EGF) algorithm technology (Ablamap® Software) to identify
AF sources and guide ablation therapy in patients with persistent atrial
fibrillation.
Study design
Study Design:
The FLOW-AF study is a prospective, multi-center study conducted to assess the
safety and efficacy of the Ablamap® Software System for patients with a history
of persistent atrial fibrillation. This study will enroll up to 100 subjects.
Subjects Patients that present with persistent atrial fibrillation and, meet
eligibility, and have had a previous ablation procedure prior to being enrolled
in the study will be eligible for enrollment. All subjects must be in AF at
the time of the procedure.
Recurrence Procedures: Subjects who present with symptoms of AF at any time
following the Randomization procedure and are indicated for a re-repeat
ablation (regardless of randomization assignment).
Study burden and risks
1. Anticipated Risks associated with the Ablamap® Software
There are no patient or user safety issues or hazards identified for the
Ablamap® Software in the clinical data analyzed within a comprehensive
literature review. Internal data generated as part of the risk analysis of the
Ablamap® Software indicates there were no patient or user safety issues or
hazards identified.
The Ablamap® Software Safety Classification per BS EN 62304:2006+A1:2015 is
Safety Class A where the hazard probability is Improbable and the hazard
severity is Negligible.
Current market experience shows no evidence to suggest that the Ablamap®
Software poses any safety issues or any hazards and there are no safety issues
or hazards that outweigh the benefits of the system.
2. Risks Associated with Participation in the Clinical Study
There are no specific tests outside the standard practice required by this
clinical study protocol. Therefore, there is no foreseen increased risk to
subjects for participating in the clinical study.
3. Anticipated Benefits
The benefit to the subjects enrolled in this study is the potential for
improved judgement by the clinician due to the additional information provided
by the Ablamap® software. Specifically, the software analyses will guide and
support treatment therapy to allow targeted ablation techniques for the
clinician which may improve acute and long-term clinical outcomes.
4800 Wadsworth Blvd Suite 310
Wheat Ridge, CO 80033
US
4800 Wadsworth Blvd Suite 310
Wheat Ridge, CO 80033
US
Listed location countries
Age
Inclusion criteria
1. Suitable candidate for intra-cardiac mapping and ablation of arrhythmias
2. Above eighteen (18) years of age or of legal age to give informed consent
specific to state and national law
3. Subjects with a history of documented symptomatic, persistent or
longstanding persistent atrial fibrillation < 36 months
4. Subject agrees to comply with study procedures and be available
(geographically stable) for follow-up visits for at least 12 months
5. Treatment of atrial fibrillation with ablation therapy presenting with
recurrent symptoms of AF
Exclusion criteria
1. LA diameter > 5.5 cm.
2. Left ventricular ejection fraction (LVEF) < 35%
3. Presence of intramural thrombus, tumor or abnormality that precludes
vascular access, catheter introduction or manipulation
4. Coagulopathy, bleeding diathesis or suspected procoagulant state
5. Known allergies or intolerance to anticoagulant and antiplatelet therapies
to be used in conjunction with the study or contrast sensitivity that cannot be
adequately pre-treated prior to the ablation procedure
6. Positive pregnancy test results for female patients of childbearing
potential or breast feeding
7. Acute or chronic medical condition that in the judgment of the investigator
would increase risk to the patient or deem the patient inappropriate to
participate in the study
8. Mitral valve stenosis and/ or severe mitral regurgitation
9. Valvular atrial fibrillation
10. Prosthetic valves
11. NYHA Class IV
12. History of MI within 3 months prior to procedure
13. Atrial septal defect (ASD) or Left Atrial Appendage (LAA) closure device.
14. Atrial fibrillation from a reversible cause (e.g., surgery,
hyperthyroidism, sarcoidosis or pericarditis)
15. Life expectancy < 12 months based on medical history or the medical
judgement of the investigator
16. Presence of any transvenous pacing, ICD, or CRT leads
Design
Recruitment
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 |
|---|---|
| CCMO | NL71156.078.19 |