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

June 23, 2014 updated by: Jochen B. Fiebach, Charite University, Berlin, Germany

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Charité, University Medicine Berlin, Campus Benjamin Franklin, Hindenburgdamm 30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient
Time Frame: During ablation procedure
During ablation procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI
Time Frame: within 2 days after catheter ablation
within 2 days after catheter ablation
Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI
Time Frame: 6 months after catheter ablation
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
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
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
1 year after catheter ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MACPAF
  • 4-087-08 (Other Identifier: ethic's committee Charité Berlin)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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