Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy

NCT06056557 | Completed DMC FDA Device

• 1 other identifier: STUDY-23-00978
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation, Paroxysmal or Persistent; Atrial Fibrillation and Flutter; Atrial Flutter Typical

Outcome Measures

Primary Outcomes (1)

• Number of participants with acute procedural success

  Acute procedural success is defined according to the type of arrhythmia, for example: * Entrance block in all targeted PVs for patients treated for atrial fibrillation (Both first and Re-Do) * Termination of atrial flutters for patients presenting in atrial flutter.

  up to 12 months post-procedure

Secondary Outcomes (11)

• Percentage of time spent in atrial flutter/fibrillation/tachycardia

  up to 12 months post-procedure

• Percentage of patients with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration

  after 3-month blanking period until end of 12 months of follow-up

• Percentage of patients presenting with persistent atrial fibrillation with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds

  after 3-month blanking period until end of 12 months of follow-up

• Percentage of patients who do not report recurrent of symptomatic arrhythmias

  after 3-month blanking period until end of 12 months of follow-up

• Percentage of patients taking anti-arrhythmic medications with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds

  after 3-month blanking period until end of 12 months of follow-up

Study Arms (1)

Interventional

EXPERIMENTAL

All patients will receive the intervention. That is, all patients will undergo ablation with the experimental catheter (device).

Device: VARIPULSE™ catheter ablation

Interventions

VARIPULSE™ catheter ablation DEVICE

Subjects will arrive to the electrophysiology laboratory for their ablation procedure and will undergo preparation for the procedure per standard protocol. The purpose of an ablation procedure is to scar or destroy the heart tissue causing the atrial fibrillation. The current FDA approved ablation treatments commonly use freezing, radio frequency, or laser, delivered through a catheter that is threaded through blood vessels to the heart, as the energy source to destroy the abnormal tissue. The BWI IRE VARIPULSE ablation system used in this study uses a type of energy source called pulse field. Pulse field ablation applies ultra-rapid (less than 1 second) electrical fields to the heart muscle to destroy the abnormal tissue. This type of energy is thought to safer and more effective at treating atrial fibrillation. ● For a lesion set that cannot be performed using the VARIPULSE catheter technology, a conventional FDA-approved RF ablation

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivek Reddy: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 28, 2023
• Study Start: September 28, 2023
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)