Clinical trial NCT00196170: Randomized Study of Radiofrequency- vs. Cryo-Ablation for Typical Isthmus-Dependent Atrial Flutter
Official title: Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Flutter
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2005-09-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Acute Efficacy (bidirectional cavotricuspid isthmus block)
timeFrame: bidirectional cavotricuspid isthmus block
measure: Long-term efficacy (6 months FU freedom of typical atrial flutter)
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
measure: Patients' pain scores during ablation
timeFrame: while hospitalisation
measure: Safety of ablational devices
timeFrame: 6 months
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
city: Muenster
country: Germany
facility: Westfälische Wilhelms-Universitaet Muenster
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg Sued
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Claus Schmitt, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Bernhard Zrenner, MD
role: PRINCIPAL_INVESTIGATOR
References: