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NCT01583075 Clinical Trial

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

Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation Clinical Trial

Official title:
Pulmonary Vein Ablation With Magnetic Navigation in Patients With Therapy-refractory Symptomatic Atrial Fibrillation: Comparison of "Single Ring" and Circumferential Ablation Techniques

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01583075
Other study ID # STXS 10-005
Secondary ID
Status Completed
Phase N/A
First received April 20, 2012
Last updated April 23, 2012
Start date December 2009

Study information
Verified date April 2012
Source University Medical Center Goettingen
Contact n/a
Is FDA regulated No
Health authority Germany: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- drug refractory AF patients undergoing PVA

Exclusion Criteria:

- drug refractory AF patients undergoing repeat PVA

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Atrial Fibrillation
  • Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation

Intervention

Procedure:
• Circumferential pulmonary vein ablation
Circumferential pulmonary vein ablation
• single ring pulmonary vein ablation
single ring pulmonary vein ablation

Locations
Country Name City State
Germany UMC Göttingen Göttingen Niedersachsen

Sponsors (2)
Lead Sponsor Collaborator
University Medical Center Goettingen Stereotaxis

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Acute procedural success number of PVs isolated at the end of the ablation procedure After the end of the ablation procedure No
Secondary Long-term procedural success long-term freedom from any AT/AF episodes 12 months No