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

Primary Purpose

Symptomatic Paroxysmal Atrial Fibrillation

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Arctic Front® catheter vs. HD Mesh Ablator® catheter
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Paroxysmal Atrial Fibrillation focused on measuring MRI, left-sided atrial catheter ablation, paroxysmal atrial fibrillation, cryoballoon technique, mesh ablator catheter, stroke, silent stroke, major complications

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arctic Front® catheter

HD Mesh Ablator® catheter

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient

Secondary Outcome Measures

Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI
Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI
Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®)
Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade)
Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation

Full Information

First Posted
February 2, 2010
Last Updated
June 23, 2014
Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01061931
Brief Title
Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation
Acronym
MACPAF
Official Title
HD Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation - Efficiency and Safety of PV Ablation Systems
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
reason
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Paroxysmal Atrial Fibrillation
Keywords
MRI, left-sided atrial catheter ablation, paroxysmal atrial fibrillation, cryoballoon technique, mesh ablator catheter, stroke, silent stroke, major complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arctic Front® catheter
Arm Type
Active Comparator
Arm Title
HD Mesh Ablator® catheter
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Arctic Front® catheter vs. HD Mesh Ablator® catheter
Intervention Description
Pulmonary vein ablation in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® catheter versus the HD Mesh Ablator® catheter
Primary Outcome Measure Information:
Title
Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient
Time Frame
During ablation procedure
Secondary Outcome Measure Information:
Title
Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI
Time Frame
within 2 days after catheter ablation
Title
Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI
Time Frame
6 months after catheter ablation
Title
Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®)
Time Frame
1 year after catheter ablation
Title
Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade)
Time Frame
within 1 month after catheter ablation
Title
Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation
Time Frame
1 year after catheter ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Schirdewan, MD
Organizational Affiliation
Department of Cardiology, Charité - University Medicine Berlin, Germany.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jochen B Fiebach, MD
Organizational Affiliation
Center for Stroke Research Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité, University Medicine Berlin, Campus Benjamin Franklin, Hindenburgdamm 30
City
Berlin
ZIP/Postal Code
12200
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31992513
Citation
Herm J, Schirdewan A, Koch L, Wutzler A, Fiebach JB, Endres M, Kopp UA, Haeusler KG. Impact of atrial fibrillation burden on cognitive function after left atrial ablation - Results of the MACPAF study. J Clin Neurosci. 2020 Mar;73:168-172. doi: 10.1016/j.jocn.2019.12.030. Epub 2020 Jan 25.
Results Reference
derived
PubMed Identifier
28243592
Citation
Schirdewan A, Herm J, Roser M, Landmesser U, Endres M, Koch L, Haeusler KG. Loop Recorder Detected High Rate of Atrial Fibrillation Recurrence after a Single Balloon- or Basket-Based Ablation of Paroxysmal Atrial Fibrillation: Results of the MACPAF Study. Front Cardiovasc Med. 2017 Feb 13;4:4. doi: 10.3389/fcvm.2017.00004. eCollection 2017.
Results Reference
derived
PubMed Identifier
23989301
Citation
Herm J, Fiebach JB, Koch L, Kopp UA, Kunze C, Wollboldt C, Brunecker P, Schultheiss HP, Schirdewan A, Endres M, Haeusler KG. Neuropsychological effects of MRI-detected brain lesions after left atrial catheter ablation for atrial fibrillation: long-term results of the MACPAF study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):843-50. doi: 10.1161/CIRCEP.113.000174. Epub 2013 Aug 29.
Results Reference
derived
PubMed Identifier
22913568
Citation
Haeusler KG, Koch L, Herm J, Kopp UA, Heuschmann PU, Endres M, Schultheiss HP, Schirdewan A, Fiebach JB. 3 Tesla MRI-detected brain lesions after pulmonary vein isolation for atrial fibrillation: results of the MACPAF study. J Cardiovasc Electrophysiol. 2013 Jan;24(1):14-21. doi: 10.1111/j.1540-8167.2012.02420.x. Epub 2012 Aug 22.
Results Reference
derived
PubMed Identifier
22523379
Citation
Koch L, Haeusler KG, Herm J, Safak E, Fischer R, Malzahn U, Werncke T, Heuschmann PU, Endres M, Fiebach JB, Schultheiss HP, Schirdewan A. Mesh ablator vs. cryoballoon pulmonary vein ablation of symptomatic paroxysmal atrial fibrillation: results of the MACPAF study. Europace. 2012 Oct;14(10):1441-9. doi: 10.1093/europace/eus084. Epub 2012 Apr 20.
Results Reference
derived
PubMed Identifier
21070885
Citation
Haeusler KG, Koch L, Ueberreiter J, Coban N, Safak E, Kunze C, Villringer K, Endres M, Schultheiss HP, Fiebach JB, Schirdewan A. Safety and reliability of the insertable Reveal XT recorder in patients undergoing 3 Tesla brain magnetic resonance imaging. Heart Rhythm. 2011 Mar;8(3):373-6. doi: 10.1016/j.hrthm.2010.11.008. Epub 2010 Nov 9.
Results Reference
derived
PubMed Identifier
20663131
Citation
Haeusler KG, Koch L, Ueberreiter J, Endres M, Schultheiss HP, Heuschmann PU, Schirdewan A, Fiebach JB. Stroke risk associated with balloon based catheter ablation for atrial fibrillation: Rationale and design of the MACPAF Study. BMC Neurol. 2010 Jul 21;10:63. doi: 10.1186/1471-2377-10-63.
Results Reference
derived

Learn more about this trial

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

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