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

German Heart Center Munich

Status and phase: Unknown; Phase 4

Conditions: Atrial Flutter

Treatments: Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus; Procedure: cryo ablation of the cavo-tricuspid isthmus; Procedure: RF ablation of the cavo-tricuspid isthmus; Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00196170

GE IDE No. C00303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 4 patient groups

1

Experimental group

Description:

8mm tip ablation catheter for ablation of cavotricuspid isthmus

Treatment:

Procedure: RF ablation of the cavo-tricuspid isthmus

2

Experimental group

Description:

irrigated tip ablation catheter for ablation of cavotricuspid isthmus

Treatment:

Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus

3

Experimental group

Description:

cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus

Treatment:

Procedure: cryo ablation of the cavo-tricuspid isthmus

4

Experimental group

Description:

Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus

Treatment:

Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmus