Clinical trial NCT01061931: Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Symptomatic Paroxysmal Atrial Fibrillation
Keywords: MRI
left-sided atrial catheter ablation
paroxysmal atrial fibrillation
cryoballoon technique
mesh ablator catheter
stroke
silent stroke
major complications
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2010-02-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient
timeFrame: During ablation procedure
Secondary outcomes:
measure: Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI
timeFrame: within 2 days after catheter ablation
measure: Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI
timeFrame: 6 months after catheter ablation
measure: Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®)
timeFrame: 1 year after catheter ablation
measure: Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade)
timeFrame: within 1 month after catheter ablation
measure: Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation
timeFrame: 1 year after catheter ablation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité, University Medicine Berlin, Campus Benjamin Franklin, Hindenburgdamm 30
Study officials:
affiliation: Department of Cardiology, Charité - University Medicine Berlin, Germany.
name: Alexander Schirdewan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Stroke Research Berlin
name: Jochen B Fiebach, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.