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

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ClinicalTrials.gov Identifier: NCT01583075
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : April 24, 2012
Sponsor:
Collaborator:
Stereotaxis
Information provided by (Responsible Party):
Markus Zabel, University Medical Center Goettingen

Brief Summary:

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 or disease Intervention/treatment
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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : December 2009
Primary Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Acute procedural success [ Time Frame: After the end of the ablation procedure ]
    number of PVs isolated at the end of the ablation procedure


Secondary Outcome Measures :
  1. Long-term procedural success [ Time Frame: 12 months ]
    long-term freedom from any AT/AF episodes



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • drug refractory AF patients undergoing PVA

Exclusion Criteria:

  • drug refractory AF patients undergoing repeat PVA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 23, 2012    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes