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
  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:


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
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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:
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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014