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

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Charité University Medicine Berlin

Status and phase

Terminated
Phase 4

Conditions

Symptomatic Paroxysmal Atrial Fibrillation

Treatments

Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT01061931
MACPAF
4-087-08 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

108 participants in 2 patient groups

Arctic Front® catheter
Active Comparator group
Treatment:
Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter
HD Mesh Ablator® catheter
Active Comparator group
Treatment:
Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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