Trials / Completed
CompletedNCT00196222
European Multicenter Study Radiofrequency (RF) Versus Cryo in Atrioventricular Nodal Reentry Tachycardia (AVNRT)
European Multicenter Study RF Versus Cryo in AVNRT: A Randomized Study Comparing Cryo-Energy vs. Radiofrequency-Energy Ablation Technique for AV Nodal Reentry Tachycardia (AVNRT)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 509 (actual)
- Sponsor
- Deutsches Herzzentrum Muenchen · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
In this randomized study, two energy sources for the ablation of AV nodal reentry tachycardia are compared: The standard technique of radiofrequency energy delivery is compared with the new approach of cryo-energy application.
Detailed description
The ablation of AV nodal reentry tachycardia with radiofrequency (RF) energy delivering catheters is a standard procedure and in experienced EP laboratories, the safety and efficacy of this approach is very high. However, the potential complication of higher degree AV conduction block, requiring in some instances implantation of a pacemaker, is a major drawback of this approach. We want to compare in this randomized study the safety and efficacy of standard RF ablation with the cryo-ablation technique. This relatively new technique is thought to offer more safety concerning higher degree AV conduction block.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | RF-ablation | RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia |
| PROCEDURE | cryo ablation | Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia |
Timeline
- Start date
- 2003-03-01
- Primary completion
- 2008-11-01
- Completion
- 2009-05-01
- First posted
- 2005-09-20
- Last updated
- 2013-07-04
Locations
10 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00196222. Inclusion in this directory is not an endorsement.