Clinical trial NCT06056557: Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
Official title: Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation, Paroxysmal or Persistent
Atrial Fibrillation and Flutter
Atrial Flutter Typical
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized, interventional clinical study to determine the safety and efficacy in using BWI IRE ablation system in a variety of atrial arrhythmias. All patients will receive the intervention.
Primary purpose: TREATMENT

Brief summary: The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSE™ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated ablation procedures.

Detailed description: By virtue of its efficiency, safety profile, and potential for improved efficacy in certain patient populations (e.g., thickened atrial tissue of hypertrophic cardiomyopathy (HCM) patients), there is tremendous excitement about the role of pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias. However, most PFA clinical trials enroll very selected populations and have highly focused inclusion/exclusion criteria - for example, typically only paroxysmal or persistent atrial fibrillation (AF) patients with upper age criteria are included, other disease states such as HCM are excluded, and typically redo ablation procedures are also excluded. The latter is particularly problematic since redo procedures are quite prevalent in most physicians' clinical practice.

In some sense, the incorporation of these restrictive criteria is not terribly surprising since most of the novel PFA catheters are specifically designed to perform only certain aspects of the AF ablation procedure (e.g., just PVI). That is, when there are more complex substrates (where other types of lesion sets may be needed), it may not be practical to allow a more inclusive criteria for enrollment. Of course, the downside is that the majority of the patients that are eventually treated in clinical practice are not reflected by the enrolled patient population.

The VARIPULSE™ catheter technology is a novel circular catheter with a variable loop design, containing multiple electrodes with individual irrigation pores capable of delivering pulse-field energy.

The Ablation procedure will follow the below sequence:

* Anatomical and voltage mapping of the left and/or right atrium
* To perform this mapping, the VARIPULSE bi-directional catheter or a compatible conventional FDA-approved multi-electrode mapping catheter (e.g., Pentaray, Octaray or Optrell) may be used
* Activation mapping of any-presenting or inducible atrial flutter
* Pulmonary Vein Isolation (PVI) to be achieved in all patients with atrial fibrillation (if not already achieved).
* Confirmation of entrance block with adenosine or isoproterenol challenge
* Additional ablation lesion sets are per the investigator's discretion including:

  * Posterior wall Isolation
  * Regional fractionation clusters
  * Cavo-tricuspid isthmus Line
  * Mitral Isthmus Line
  * Any micro-/macro-reentrant atrial tachycardia's
* As part of the ablation procedure, any safety assessments that are considered important (e.g., EGD, coronary angiography, etc.) may be performed; these data will also be collected.

This study is a prospective, single-center, non-randomized, interventional clinical study to determine the safety and efficacy in using BWI IRE ablation system in a variety of atrial arrhythmias. Subjects will be followed for 12 months post-procedure.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* Diagnosed with atrial fibrillation or atrial atypical atrial flutter (typical flutter may also be ablated provided that the typical flutter occurs in addition to atrial fibrillation or atypical flutter; that is, typical flutter as the sole arrhythmia should not undergo PFA).
* Previous surgical or catheter ablation for atrial fibrillation is allowed
* Planned for a catheter ablation procedure
* Able and willing to provide written consent and comply with all testing and follow-up requirements
* Have in place or are planned to receive an implantable loop recorder, pacemaker or defibrillator capable of recording atrial rhythm

Exclusion Criteria:

* Documented "active" left atrial thrombus
* Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.)
* Previous PCI/MI within the past 1 month
* Active systemic infection or sepsis
* Uncontrolled heart failure - New York Heart Association (NYHA) function class IV.
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation.
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment.
* Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial.
* Life expectancy or other disease processes likely to limit survival to less than 12 months.
* Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.

Primary outcomes:
measure: Number of participants with acute procedural success
timeFrame: up to 12 months post-procedure
Secondary outcomes:
measure: Percentage of time spent in atrial flutter/fibrillation/tachycardia
timeFrame: up to 12 months post-procedure
measure: Percentage of patients with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration
timeFrame: after 3-month blanking period until end of 12 months of follow-up
measure: Percentage of patients presenting with persistent atrial fibrillation with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds
timeFrame: after 3-month blanking period until end of 12 months of follow-up
measure: Percentage of patients who do not report recurrent of symptomatic arrhythmias
timeFrame: after 3-month blanking period until end of 12 months of follow-up
measure: Percentage of patients taking anti-arrhythmic medications with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds
timeFrame: after 3-month blanking period until end of 12 months of follow-up
measure: Percentage of patients not taking anti-arrhythmic medications with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration
timeFrame: after 3-month blanking period until end of 12 months of follow-up
measure: Durability of lesion sets in any patient that undergoes a second procedure
timeFrame: up to 12 months post-procedure
measure: Number of patient emergency room (ER) visits
timeFrame: up to 12 months post-procedure
measure: Number of patient Hospitalizations
timeFrame: up to 12 months post-procedure
measure: Number of patients requiring cardioversion
timeFrame: up to 12 months post-procedure
measure: Number of patients who experience repeat ablation
timeFrame: up to 12 months post-procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: