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

Phase 4TerminatedNCT01061931

Charite University, Berlin, Germany108 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

108

Conditions

Symptomatic Paroxysmal Atrial Fibrillation

Interventions

Arctic Front® catheter vs. HD Mesh Ablator® catheterPROCEDURE

Pulmonary vein ablation in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® catheter versus the HD Mesh Ablator® catheter

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Charité, University Medicine Berlin, Campus Benjamin Franklin, Hindenburgdamm 30

Berlin, Germany

Outcomes

Primary Outcomes

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

Time frame: During ablation procedure

Secondary Outcomes

Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI

Time frame: within 2 days after catheter ablation

Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI

Time frame: 6 months after catheter ablation

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

Time frame: 1 year after catheter ablation

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

Time frame: within 1 month after catheter ablation

Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation

Time frame: 1 year after catheter ablation

Data from ClinicalTrials.gov

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