Pulmonary Vein Ablation of Atrial Fibrillation Using Magnetic Navigation: Single Ring Versus Circumferential Techniques

This study has been completed.

Sponsor:

Collaborator:

Stereotaxis

Information provided by (Responsible Party):

Markus Zabel, University Medical Center Goettingen

ClinicalTrials.gov Identifier:

NCT01583075

First received: April 20, 2012

Last updated: April 23, 2012

Last verified: April 2012

History of Changes

Purpose

The single-ring ablation method aims for isolation of the posterior LA wall including the pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely.

Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided single-ring ablation method as compared to standard RMN-guided circumferential PVA.

Condition	Intervention
Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation	Procedure: Circumferential pulmonary vein ablation Procedure: single ring pulmonary vein ablation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Pulmonary Vein Ablation With Magnetic Navigation in Patients With Therapy-refractory Symptomatic Atrial Fibrillation: Comparison of "Single Ring" and Circumferential Ablation Techniques

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by University Medical Center Goettingen:

Primary Outcome Measures:

Acute procedural success [ Time Frame: After the end of the ablation procedure ] [ Designated as safety issue: No ]
number of PVs isolated at the end of the ablation procedure

Secondary Outcome Measures:

Long-term procedural success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
long-term freedom from any AT/AF episodes

Enrollment:	80
Study Start Date:	December 2009
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Circumferential ablation	Procedure: Circumferential pulmonary vein ablation Circumferential pulmonary vein ablation
Experimental: Single ring ablation	Procedure: single ring pulmonary vein ablation single ring pulmonary vein ablation

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

drug refractory AF patients undergoing PVA

Exclusion Criteria:

drug refractory AF patients undergoing repeat PVA

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583075

Locations

Germany
UMC Göttingen
Göttingen, Niedersachsen, Germany, 37075

Sponsors and Collaborators

University Medical Center Goettingen

Stereotaxis

Investigators

Principal Investigator:

Markus Zabel, MD

Clinical Electrophysiology, University Medical Center Goettingen

More Information

Publications:

Thomas SP, Lim TW, McCall R, Seow SC, Ross DL. Electrical isolation of the posterior left atrial wall and pulmonary veins for atrial fibrillation: feasibility of and rationale for a single-ring approach. Heart Rhythm. 2007 Jun;4(6):722-30. Epub 2007 Feb 9.

Responsible Party:	Markus Zabel, Prof. Dr. Markus Zabel, University Medical Center Goettingen
ClinicalTrials.gov Identifier:	NCT01583075 History of Changes
Other Study ID Numbers:	STXS 10-005
Study First Received:	April 20, 2012
Last Updated:	April 23, 2012
Health Authority:	Germany: Ministry of Health

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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