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Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00196183
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 18, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: trigger-guided catheter-ablation Procedure: trigger+substrate-guided catheter ablation Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study Comparing Pulmonary Vein Isolation Alone vs. Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation
Study Start Date : August 2004
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
trigger-guided ablation of paroxysmal atrial fibrillation
Procedure: trigger-guided catheter-ablation
trigger-guided ablation of paroxysmal atrial fibrillation
Experimental: 2
trigger-+substrate guided ablation of paroxysmal atrial fibrillation
Procedure: trigger+substrate-guided catheter ablation
trigger-+substrate guided ablation of paroxysmal atrial fibrillation



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196183


Locations
Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Claus Schmitt, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Isabel Deisenhofer, MD Deutsches Herzzentrum Muenchen