Symptomatic Paroxysmal Atrial Fibrillation Clinical Trial
— MACPAFOfficial title:
HD Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation - Efficiency and Safety of PV Ablation Systems
| Verified date | June 2014 |
| Source | Charite University, Berlin, Germany |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 108 |
| Est. completion date | November 2011 |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charité, University Medicine Berlin, Campus Benjamin Franklin, Hindenburgdamm 30 | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany | German Federal Ministry of Education and Research |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient | During ablation procedure | No | |
| Secondary | Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI | within 2 days after catheter ablation | Yes | |
| Secondary | Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI | 6 months after catheter ablation | No | |
| Secondary | Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®) | 1 year after catheter ablation | No | |
| Secondary | Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade) | within 1 month after catheter ablation | Yes | |
| Secondary | Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation | 1 year after catheter ablation | Yes |