search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Circumferential pulmonary vein ablation
single ring pulmonary vein ablation
Sponsored by
University Medical Center Goettingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • drug refractory AF patients undergoing PVA

Exclusion Criteria:

  • drug refractory AF patients undergoing repeat PVA

Sites / Locations

  • UMC Göttingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Circumferential ablation

Single ring ablation

Arm Description

Outcomes

Primary Outcome Measures

Acute procedural success
number of PVs isolated at the end of the ablation procedure

Secondary Outcome Measures

Long-term procedural success
long-term freedom from any AT/AF episodes

Full Information

First Posted
April 20, 2012
Last Updated
April 23, 2012
Sponsor
University Medical Center Goettingen
Collaborators
Stereotaxis
search

1. Study Identification

Unique Protocol Identification Number
NCT01583075
Brief Title
Pulmonary Vein Ablation of Atrial Fibrillation Using Magnetic Navigation: Single Ring Versus Circumferential Techniques
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 Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Goettingen
Collaborators
Stereotaxis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Circumferential ablation
Arm Type
Other
Arm Title
Single ring ablation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Circumferential pulmonary vein ablation
Intervention Description
Circumferential pulmonary vein ablation
Intervention Type
Procedure
Intervention Name(s)
single ring pulmonary vein ablation
Intervention Description
single ring pulmonary vein ablation
Primary Outcome Measure Information:
Title
Acute procedural success
Description
number of PVs isolated at the end of the ablation procedure
Time Frame
After the end of the ablation procedure
Secondary Outcome Measure Information:
Title
Long-term procedural success
Description
long-term freedom from any AT/AF episodes
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: drug refractory AF patients undergoing PVA Exclusion Criteria: drug refractory AF patients undergoing repeat PVA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Zabel, MD
Organizational Affiliation
Clinical Electrophysiology, University Medical Center Goettingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Göttingen
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17556191
Citation
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. doi: 10.1016/j.hrthm.2007.01.034. Epub 2007 Feb 9.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs