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Clinical Trials/NCT00196183
NCT00196183CompletedPhase 4

Randomized Study Comparing Pulmonary Vein Isolation Alone vs. Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation

Deutsches Herzzentrum Muenchen2 sites in 1 country98 target enrollmentStarted: August 1, 2004Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
98
Locations
2
Primary Endpoint
Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Deutsches Herzzentrum Muenchen
Sponsor Class
Other

Study Sites (2)

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