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Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

NCT ID: NCT00196183

Last Updated: 2008-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

trigger-guided ablation of paroxysmal atrial fibrillation

Group Type EXPERIMENTAL

trigger-guided catheter-ablation

Intervention Type PROCEDURE

trigger-guided ablation of paroxysmal atrial fibrillation

2

trigger-+substrate guided ablation of paroxysmal atrial fibrillation

Group Type EXPERIMENTAL

trigger+substrate-guided catheter ablation

Intervention Type PROCEDURE

trigger-+substrate guided ablation of paroxysmal atrial fibrillation

Interventions

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trigger-guided catheter-ablation

trigger-guided ablation of paroxysmal atrial fibrillation

Intervention Type PROCEDURE

trigger+substrate-guided catheter ablation

trigger-+substrate guided ablation of paroxysmal atrial fibrillation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Principal Investigators

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Claus Schmitt, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Isabel Deisenhofer, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

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Deutsches Herzzentrum Muenchen

Munich, , Germany

Site Status

Countries

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Germany

References

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Karch MR, Zrenner B, Deisenhofer I, Schreieck J, Ndrepepa G, Dong J, Lamprecht K, Barthel P, Luciani E, Schomig A, Schmitt C. Freedom from atrial tachyarrhythmias after catheter ablation of atrial fibrillation: a randomized comparison between 2 current ablation strategies. Circulation. 2005 Jun 7;111(22):2875-80. doi: 10.1161/CIRCULATIONAHA.104.491530. Epub 2005 May 31.

Reference Type BACKGROUND
PMID: 15927974 (View on PubMed)

Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.

Reference Type BACKGROUND
PMID: 15172410 (View on PubMed)

Other Identifiers

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GE IDE No. C00504

Identifier Type: -

Identifier Source: org_study_id