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

Atrial Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00196170
• Other study ID #: GE IDE No. C00303
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: March 18, 2008
• Start date: May 2003
• Est. completion date: July 2008

Study information

• Verified date: March 2008
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Germany	Herz-Zentrum Bad Krozingen	Bad Krozingen
Germany	Westfälische Wilhelms-Universitaet Muenster	Muenster
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Klinikum Nuernberg Sued	Nuernberg

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Boston Scientific Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Efficacy (bidirectional cavotricuspid isthmus block)		bidirectional cavotricuspid isthmus block	No
Primary	Long-term efficacy (6 months FU freedom of typical atrial flutter)		6 months	No
Primary	Mortality		6 months	No
Secondary	Patients' pain scores during ablation		while hospitalisation	No
Secondary	Safety of ablational devices		6 months	No