Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: trigger-guided catheter-ablation; Procedure: trigger+substrate-guided catheter ablation

• Registration Number: NCT00196183
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

The purpose of this study is to compare two strategies of catheter-based treatment of paroxysmal atrial fibrillation: Pulmonary vein isolation either alone or combined with electrogram-guided substrate-ablation.

Detailed Description

Catheter ablation has evolved an accepted alternative in the curative treatment of atrial fibrillation (AF). However, discussion about the best ablation strategy is still ongoing.

In patients with paroxysmal AF, it has been reproducibly demonstrated that curing rates of approximately 65-70% can be achieved with the electric isolation of pulmonary veins (PV) eliminating the initiating triggers of AF episodes. Recently, a new catheter ablation approach targeting in both atria fractionated, complex electrograms during ongoing AF and modifying thus the substrate maintaining AF has been described. The first describer of this technique reports curing rates of 92%. We want to compare in a randomized prospective study the treatment by PV isolation alone with a combined approach of PV isolation together with ablation of fractionated complex electrograms in patients with paroxysmal AF. Study endpoint is the achievement of stable sinus rhythm as assessed by 7 days holter ECG in the absence of antiarrhythmic drug treatment.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-20
• Study Completion: 2006-06
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-14
• Last Update Posted: 2008-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Age > 18 and <80 years
• Symptomatic paroxysmal atrial fibrillation
• Drug-refractory
• Anticoagulation

Exclusion Criteria

• Hyperthyreosis
• Moderate-to-severe mitral valve valvulopathy
• LV-ejection fraction <35%
• Prior ablation, PCI or heart surgery <3 months
• Left atrial thrombus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	trigger-guided catheter-ablation	trigger-guided ablation of paroxysmal atrial fibrillation
2	trigger+substrate-guided catheter ablation	trigger-+substrate guided ablation of paroxysmal atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation	Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation

Trial Locations

Locations (1)

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany