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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Symptomatic Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Arctic Front® catheter

Group Type ACTIVE_COMPARATOR

Arctic Front® catheter vs. HD Mesh Ablator® catheter

Intervention Type PROCEDURE

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

HD Mesh Ablator® catheter

Group Type ACTIVE_COMPARATOR

Arctic Front® catheter vs. HD Mesh Ablator® catheter

Intervention Type PROCEDURE

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

Interventions

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Arctic Front® catheter vs. HD Mesh Ablator® catheter

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No