Randomized Study of Radiofrequency- vs. Cryo-Ablation for Typical Isthmus-Dependent Atrial Flutter - Full Text View

Purpose

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 regarding the acute and long term efficacy and safety.

Condition	Intervention	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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

Acute Efficacy (bidirectional cavotricuspid isthmus block) [ Time Frame: bidirectional cavotricuspid isthmus block ] [ Designated as safety issue: No ]
Long-term efficacy (6 months FU freedom of typical atrial flutter) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patients' pain scores during ablation [ Time Frame: while hospitalisation ] [ Designated as safety issue: No ]
Safety of ablational devices [ Time Frame: 6 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	500
Study Start Date:	May 2003
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 8mm tip ablation catheter for ablation of cavotricuspid isthmus	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
Experimental: 2 irrigated tip ablation catheter for ablation of cavotricuspid isthmus	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
Experimental: 3 cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus	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
Experimental: 4 Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus	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

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196170

Locations


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

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Boston Scientific Corporation

Investigators


Study Chair:	Claus Schmitt, MD	Deutsches Herzzentrum Muenchen
Principal Investigator:	Bernhard Zrenner, MD	Deutsches Herzzentrum Muenchen

More Information


Responsible Party:	Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier:	NCT00196170 History of Changes
Other Study ID Numbers:	GE IDE No. C00303
Study First Received:	September 12, 2005
Last Updated:	March 18, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:


Atrial Flutter Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016