Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00196183
First received: September 12, 2005
Last updated: March 14, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Atrial Fibrillation
Procedure: trigger-guided catheter-ablation
Procedure: trigger+substrate-guided catheter ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study Comparing Pulmonary Vein Isolation Alone vs. Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • 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 ]

Enrollment: 98
Study Start Date: August 2004
Study Completion Date: June 2006
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00196183     History of Changes
Other Study ID Numbers: GE IDE No. C00504
Study First Received: September 12, 2005
Last Updated: March 14, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014