Skip to main content
OpenTrials
Completed

NCT Number: NCT00196183

Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

trigger-guided catheter-ablation

Procedure

trigger-guided ablation of paroxysmal atrial fibrillation

trigger+substrate-guided catheter ablation

Procedure

trigger-+substrate guided ablation of paroxysmal atrial fibrillation

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Mar 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.