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

This study has been terminated.
(reason)
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01061931
First received: February 2, 2010
Last updated: January 19, 2011
Last verified: December 2010
History of Changes

February 2, 2010
January 19, 2011
March 2009
November 2010   (final data collection date for primary outcome measure)
Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient [ Time Frame: During ablation procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01061931 on ClinicalTrials.gov Archive Site
  • Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI [ Time Frame: within 2 days after catheter ablation ] [ Designated as safety issue: Yes ]
  • Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI [ Time Frame: 6 months after catheter ablation ] [ Designated as safety issue: No ]
  • Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®) [ Time Frame: 1 year after catheter ablation ] [ Designated as safety issue: No ]
  • Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade) [ Time Frame: within 1 month after catheter ablation ] [ Designated as safety issue: Yes ]
  • Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation [ Time Frame: 1 year after catheter ablation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation
HD Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation - Efficiency and Safety of PV Ablation Systems

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Symptomatic Paroxysmal Atrial Fibrillation
Procedure: 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
  • Active Comparator: Arctic Front® catheter
    Intervention: Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter
  • Active Comparator: HD Mesh Ablator® catheter
    Intervention: Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
108
November 2011
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01061931
MACPAF, 4-087-08
No
Dr. Alexander Schirdewan, MD, Department of Cardiology, Charité - University Medicine Berlin, Germany
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Principal Investigator: Alexander Schirdewan, MD Department of Cardiology, Charité - University Medicine Berlin, Germany.
Principal Investigator: Jochen B Fiebach, MD Center for Stroke Research Berlin, Germany
Charite University, Berlin, Germany
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP