Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196183
• Other study ID #: GE IDE No. C00504
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: March 14, 2008
• Start date: August 2004
• Est. completion date: June 2006

Study information

• Verified date: March 2008
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• trigger-guided catheter-ablation
trigger-guided ablation of paroxysmal atrial fibrillation
• trigger+substrate-guided catheter ablation
trigger-+substrate guided ablation of paroxysmal atrial fibrillation

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Karch MR, Zrenner B, Deisenhofer I, Schreieck J, Ndrepepa G, Dong J, Lamprecht K, Barthel P, Luciani E, Schömig 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. Epub 2005 May 31. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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