Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation - Full Text View

Sponsor:	Charite University, Berlin, Germany
Collaborator:	German Federal Ministry of Education and Research
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01061931

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

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
Estimated 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

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, Germany

More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Dr. Alexander Schirdewan, MD, Department of Cardiology, Charité - University Medicine 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:	January 19, 2011
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 May 23, 2012