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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

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

Phoenix Cardiovascular Research Group
Phoenix, Arizona 85018

Tucson Medical Center Pima Heart and Vascular
Tucson, Arizona 85704

OC Memorial
Fountain Valley, California 92708

Community Memorial Hospital
Ventura, California 93003

Aurora Denver Cardiology Associates
Aurora, Colorado 80012

Orlando Health Heart and Vascular Institute
Orlando, Florida 32806

The Kansas City Heart Rhythm Institute
Overland Park, Kansas 66211

Trinity Health
Ypsilanti, Michigan 48197

Albert Einstein College Of Medicine - Montefiore Medical Center
The Bronx, New York 10467

Springfield Medical Center
Springfield, Ohio 45504

Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705

Baylor Scott and White Research Institute
Fort Worth, Texas 76104

Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Plano, Texas 75093

Winchester Medical Center
Winchester, Virginia 22601

Mercy Hospital
Janesville, Wisconsin 53548

More Details

Status
Recruiting
Sponsor
Biosense Webster, Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.