Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

Not Applicable

Completed

• Conditions: Catheter Ablation Strategies; Paroxysmal Atrial Fibrillation
• Interventions: Device: catheter based pulmonary vein isolation

• Registration Number: NCT01724437
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

to assess the near-term (12 months) efficacy of pulmonary vein isolation.

Detailed Description

The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-11
• Study Completion: 2012-11
• Study First Submitted: 2012-11-04
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-27
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• written informed consent
• age > 18 years
• paroxysmal atrial fibrillation

Exclusion Criteria

• structural heart disease
• intracardiac thrombus
• reversible causes of atrial fibrillation
• inability to take warfarin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loss of pace capture	catheter based pulmonary vein isolation	Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved catheter based pulmonary vein isolation
Conventional	catheter based pulmonary vein isolation	Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved. catheter based pulmonary vein isolation

Primary Outcome Measures

Name	Time	Method
time to AF and AT recurrence	12 months	recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring

Secondary Outcome Measures

Name	Time	Method
procedure duration	completed (15 months)	time needed to complete the procedure
procedure safety	up to three days after the procedure	complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed

Trial Locations

Locations (1)

University Hospital Hamburg; 🇩🇪 Hamburg, Germany