A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

Purpose

The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).

Condition

  • Atrial Fibrillation

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF - Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD) - Willing and capable of providing consent - Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria

  • Previously diagnosed with persistent or long-standing persistent AF (more than [>] 7 days in duration) - Previous surgical or catheter ablation for AF - Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF - Current enrollment in an investigational study evaluating another device or drug - Life expectancy less than 12 months - Any contraindications as defined in the Protocol

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator 		Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator.
  • Device: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
    Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Biosense Webster, Inc.

Study Contact

Emily Purcell
+1 949 230 3701
EPurcel1@its.jnj.com