Randomized Study of Radiofrequency- vs. Cryo-Ablation for Typical Isthmus-Dependent Atrial Flutter
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| ClinicalTrials.gov Identifier: NCT00196170 |
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Recruitment Status
: Unknown
Verified March 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was: Active, not recruiting
First Posted
: September 20, 2005
Last Update Posted
: March 19, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Flutter | Procedure: RF ablation of the cavo-tricuspid isthmus Procedure: cryo ablation of the cavo-tricuspid isthmus Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmus | Phase 4 |
This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and the cryo-ablation technique. The RF ablation of typical atrial flutter has become a standard approach with very high curing rates and low complication incidence. However, ablation with RF is painful since the underlying cardiac tissue heats up (up to 70-80°C inside the tissue) and especially the target of ablation in typical atrial flutter, the so-called cavo-tricuspid isthmus, is a very pain-receptive area. Cryo-ablation, which destroys tissue by freezing it down to -80 to -90°C, is thought to be less painful or even painless with the same efficacy than RF ablation.
The acute and long term (6 months follow-up, non-invasive) efficacy and safety is the combined endpoint.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter |
| Study Start Date : | May 2003 |
| Estimated Primary Completion Date : | April 2008 |
| Estimated Study Completion Date : | July 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
8mm tip ablation catheter for ablation of cavotricuspid isthmus
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Procedure: RF ablation of the cavo-tricuspid isthmus
8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
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Experimental: 2
irrigated tip ablation catheter for ablation of cavotricuspid isthmus
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Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus
irrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
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Experimental: 3
cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus
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Procedure: cryo ablation of the cavo-tricuspid isthmus
Cryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
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Experimental: 4
Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus
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Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmus
cryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
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- Acute Efficacy (bidirectional cavotricuspid isthmus block) [ Time Frame: bidirectional cavotricuspid isthmus block ]
- Long-term efficacy (6 months FU freedom of typical atrial flutter) [ Time Frame: 6 months ]
- Mortality [ Time Frame: 6 months ]
- Patients' pain scores during ablation [ Time Frame: while hospitalisation ]
- Safety of ablational devices [ Time Frame: 6 months ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age between 18 and 80 years
- documented atrial flutter which is most probably typical isthmus dependent atrial flutter
- informed written consent
Exclusion Criteria:
- prior ablation for atrial flutter
- concomitant arrhythmia which is treated during the same ablation procedure
- prior MAZE operation
- contra indication for catheterization
- physical or psychiatric disorder making participation in the study impossible
- pregnancy
- prior participation in the study
- participation in another study
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): NCT00196170
| Germany | |
| Herz-Zentrum Bad Krozingen | |
| Bad Krozingen, Germany, 79189 | |
| Westfälische Wilhelms-Universitaet Muenster | |
| Muenster, Germany, 48149 | |
| Deutsches Herzzentrum Muenchen | |
| Munich, Germany, 80636 | |
| Klinikum Nuernberg Sued | |
| Nuernberg, Germany, 90471 | |
| Study Chair: | Claus Schmitt, MD | Deutsches Herzzentrum Muenchen | |
| Principal Investigator: | Bernhard Zrenner, MD | Deutsches Herzzentrum Muenchen |
| Responsible Party: | Prof. A. Schömig, Deutsches Herzzentrum Munich |
| ClinicalTrials.gov Identifier: | NCT00196170 History of Changes |
| Other Study ID Numbers: |
GE IDE No. C00303 |
| First Posted: | September 20, 2005 Key Record Dates |
| Last Update Posted: | March 19, 2008 |
| Last Verified: | March 2008 |
Additional relevant MeSH terms:
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Atrial Flutter Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |