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

Phase 4

Terminated

• Conditions: Symptomatic Paroxysmal Atrial Fibrillation
• Interventions: Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter

• Registration Number: NCT01061931
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Primary Completion: 2010-11
• Study Completion: 2011-11
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Patients with ECG-documented symptomatic paroxysmal atrial fibrillation and at least one ineffective antiarrhythmic drug treatment

Exclusion Criteria

• Previous ablation procedure for atrial fibrillation or cardiac surgery within 3 months
• Left atrial diameter > 50mm or ejection fraction < 35%
• Instable coronary artery disease or clinically relevant cardiac valve insufficiency
• Hyperthyroidism, pregnancy or lactation; coumadin or heparin intolerance
• Concomitant disease with expected lifespan < 2 years
• Contraindications for MRI or acute cerebral infarction detected by brain MRI immediately (< 24 hours) before catheter ablation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arctic Front® catheter	Arctic Front® catheter vs. HD Mesh Ablator® catheter	-
HD Mesh Ablator® catheter	Arctic Front® catheter vs. HD Mesh Ablator® catheter	-

Primary Outcome Measures

Name	Time	Method
Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient	During ablation procedure

Secondary Outcome Measures

Name	Time	Method
Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI	6 months after catheter ablation
Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®)	1 year after catheter ablation
Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade)	within 1 month after catheter ablation
Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation	1 year after catheter ablation

Trial Locations

Locations (1)

Charité, University Medicine Berlin, Campus Benjamin Franklin, Hindenburgdamm 30; 🇩🇪 Berlin, Germany