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Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation

2014-08-27 03:16:09 | BioPortfolio

Summary

The purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter.

Description

Primary objective:

• Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient.

Secondary objectives:

- Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI prior and within 2 days after PV ablation.

- Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI within 6 months after PV ablation.

- Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®).

- Characterization of non-neurological major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade)

- Rate of iatrogenic interatrial septal defects after transseptal puncture for PV ablation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Conditions

Stroke

Intervention

Arctic Front® catheter vs. HD Mesh Ablator® catheter

Location

Charité, University Medicine Berlin, Campus Benjamin Franklin.
Berlin
Germany
12200

Status

Recruiting

Source

Charite University, Berlin, Germany

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:09-0400

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