NCT01583075

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2012

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

1.2 years

First QC Date

April 20, 2012

Last Update Submit

April 23, 2012

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Acute procedural success

    number of PVs isolated at the end of the ablation procedure

    After the end of the ablation procedure

Secondary Outcomes (1)

  • Long-term procedural success

    12 months

Study Arms (2)

Circumferential ablation

OTHER
Procedure: Circumferential pulmonary vein ablation

Single ring ablation

EXPERIMENTAL
Procedure: single ring pulmonary vein ablation

Interventions

Circumferential pulmonary vein ablationPROCEDURE

Circumferential pulmonary vein ablation

Circumferential ablation
single ring pulmonary vein ablationPROCEDURE

single ring pulmonary vein ablation

Single ring ablation

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • drug refractory AF patients undergoing PVA

You may not qualify if:

  • drug refractory AF patients undergoing repeat PVA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Related 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. doi: 10.1016/j.hrthm.2007.01.034. Epub 2007 Feb 9.

    PMID: 17556191BACKGROUND

Study Officials

  • Markus Zabel, MD

    Clinical Electrophysiology, University Medical Center Goettingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Markus Zabel

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 23, 2012

Study Start

December 1, 2009

Primary Completion

March 1, 2011

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations

DE(1)