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

Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Flutter
• Intervention / Treatment: Procedure: RF ablation of the cavo-tricuspid isthmus; Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus; Procedure: cryo ablation of the cavo-tricuspid isthmus; Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmus

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany, 79189
    • Herz-Zentrum Bad Krozingen
  • Muenster, Germany, 48149
    • Westfälische Wilhelms-Universitaet Muenster
  • Munich, Germany, 80636
    • Deutsches Herzzentrum Muenchen
  • Nuernberg, Germany, 90471
    • Klinikum Nuernberg Sued

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	6 months
Acute Efficacy (bidirectional cavotricuspid isthmus block)	bidirectional cavotricuspid isthmus block
Long-term efficacy (6 months FU freedom of typical atrial flutter)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Patients' pain scores during ablation	while hospitalisation
Safety of ablational devices	6 months

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (Anticipated): April 1, 2008
• Study Completion (Anticipated): July 1, 2008

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): March 19, 2008
• Last Update Submitted That Met QC Criteria: March 18, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: GE IDE No. C00303