RF Ablation of Atrial Fibrillation - Full Text View

Purpose

This is an early feasibility trial designed to demonstrate whether a new ablation device can be used safely and effectively in treating atrial fibrillation.

This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at 3-6 study sites

Condition	Intervention	Phase
Atrial Fibrillation	Procedure: RF catheter ablation	Phase I Phase II

Genetics Home Reference related topics:

Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Clinical Investigation of Radiofrequency Ablation for the Treatment of Atrial Fibrillation Using the RFMesh Bard Ablation System

Further study details as provided by C. R. Bard:

Primary Outcome Measures:

The primary safety endpoint is the occurence of major complications within 30 days of the RFMesh ablation procedure [ Time Frame: 30 days ]
Primary effectiveness endpoint is acute procedural success [ Time Frame: 1 day ]

Secondary Outcome Measures:

Secondary safety endpoint is the occurence of pulmonary vein stenosis in the RFMesh treated pulmonary vein. [ Time Frame: 12 months ]
The secondary effectiveness endpoint is the freedom from recurrence of atrial fibrillation at 3, 6, and 12 months post-procedure. [ Time Frame: 12 months ]

Estimated Enrollment:	20
Study Start Date:	August 2005
Estimated Study Completion Date:	February 2007

Arms	Assigned Interventions
1: Experimental RF ablation	Procedure: RF catheter ablation RF ablation using mesh device

Detailed Description:

This study is intended to evaluate the safety and preliminary effectiveness of the RFMesh BAS for electrophysiological mapping and radiofrequency ablation in the region of the ostium of a targeted pulmonary vein in the treatment of drug refractory paroxysmal atrial fibrillation.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-85 years of age
Documented paroxysmal atrial fibrillation
Failed at least one anti-arrhythmic medication

Exclusion Criteria:

Subjects taking amiodarone
Subjects with left atrium greater than 50mm
NYHA classification III or IV
Subjects with intracardiac thrombus
Subjects with a contraindication to warfarin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265629

Contacts


Contact: James M Elberfeld, BS	978-323-2276	jim.elberfeld@crbard.com

Locations


United States, California
	Anil Bhandari, MD	Recruiting
	Los Angeles, California, United States, 90017
	Contact: Stephanie Mullins, RN 213-977-7436 smullin@lacard.com

United States, Illinois
	David Wilber, MD	Recruiting
	Maywood, Illinois, United States, 60153
	Contact: Cindy Finn, RN 708-216-2646 cfinn@lumc.edu

United States, Michigan
	David Haines, MD	Recruiting
	Royal Oak, Michigan, United States, 48073
	Contact: Sheryl Workman, RN, RN 248-898-9259 sworkman@beaumont.edu
	Principal Investigator: David E Haines, MD

United States, Minnesota
	Thomas M. Munger, MD	Recruiting
	Rochester, Minnesota, United States, 55905
	Contact: Linda Hyberger, RN 507-255-8147 hyberger.linda@mayo.edu

United States, Ohio
	Raul Weiss, MD	Recruiting
	Columbus, Ohio, United States, 43214
	Contact: Georgia Dawson, RN 614-447-3562 gdawson@mocvc.com
	Andrea Natale, MD	Not yet recruiting
	Cleveland, Ohio, United States, 44195
	Contact: Mark Jarosz 216-445-6572 jaroszm@ccf.org

Sponsors and Collaborators

C. R. Bard

More Information

Study ID Numbers:	RFMesh Feasibility
First Received:	December 14, 2005
Last Updated:	October 26, 2007
ClinicalTrials.gov Identifier:	NCT00265629
Health Authority:	United States: Food and Drug Administration

Keywords provided by C. R. Bard:

Atrial fibrillation

Study placed in the following topic categories:

Heart Diseases

Atrial Fibrillation

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	C. R. Bard
Information provided by:	C. R. Bard
ClinicalTrials.gov Identifier:	NCT00265629