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 (Responsible Party):
Jochen B. Fiebach, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01061931
First received: February 2, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Symptomatic Paroxysmal Atrial Fibrillation
Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: HD Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation - Efficiency and Safety of PV Ablation Systems

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 108
Study Start Date: March 2009
Study Completion Date: November 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arctic Front® catheter 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: HD Mesh Ablator® catheter 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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061931

Locations
Germany
Charité, University Medicine Berlin, Campus Benjamin Franklin, Hindenburgdamm 30
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Alexander Schirdewan, MD Department of Cardiology, Charité - University Medicine Berlin, Germany.
Principal Investigator: Jochen B Fiebach, MD Center for Stroke Research Berlin
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jochen B. Fiebach, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01061931     History of Changes
Other Study ID Numbers: MACPAF, 4-087-08
Study First Received: February 2, 2010
Last Updated: June 23, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
MRI
left-sided atrial catheter ablation
paroxysmal atrial fibrillation
cryoballoon technique
mesh ablator catheter
stroke
silent stroke
major complications

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014