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Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation | Clinical Trials | Clareo Health

COMPLETEDNA

Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation

NCT02695277•AtriCure, Inc.

View on ClinicalTrials.gov

Summary

This is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF) ablation.The study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient has a history of symptomatic Persistent AF and a left atrium (LA) \> 4cm or Long Standing Persistent AF as defined by the HRS/EHRA/ECAS expert consensus statement
•2. Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)
•3. Patient is mentally able and willing to give informed consent

Exclusion Criteria

•1. Patient has longstanding persistent AF \> 10 years
•2. Patient presenting with paroxysmal AF
•3. Patient with persistent AF and a LA-diameter ≤ 4cm
•4. AF is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
•5. Patient underwent previous ablation procedure or heart surgery
•6. Patient needs other cardiac surgery procedures besides AF treatment (valve, coronary, others)
•7. Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, Previous cardiac tamponade, Pleural adhesions, Prior thoracotomy)
•8. Body mass index \> 35
•9. LA Diameter \> 6 cm
•10. Left ventricular ejection fraction \< 30 %
+10 more criteria

Locations (12)

Dr Tomáš Ostřížek

Brno, Czechia

Czech Budejovice Hospital, Inc.

České Budějovice, Czechia

Cardiovascular Center Bad Neustadt

Bad Neustadt an der Saale, Germany

Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück

Bad Rothenfelde, Germany

Heart Center Leipzig

Leipzig, Germany

Klinikum Ludwigsburg

Ludwigsburg, Germany

Peter Osypka Heart Center Munich

Munich, Germany

Kliniken Sindelfingen

Sindelfingen, Germany

Sana Heart Center Stuttgart

Stuttgart, Germany

St. Antonius Hospital

Nieuwegein, Netherlands

Key Dates

Start Date

November 1, 2015

Primary Completion Date

November 1, 2022

Completion Date

September 1, 2024

Last Updated

October 15, 2024

Enrollment

146

ACTUAL participants

Conditions

Atrial FibrillationPersistent and Longstanding Persistent Atrial Fibrillation

Interventions

AtriCure Bipolar System

DEVICE

Standard Endocardial Ablation with Catheter

DEVICE

AtriClip® PRO LAA Exclusion System

DEVICE

Endocardial Ablation with Catheter

DEVICE

Repeated Endocardial ablation(s)

DEVICE

The CONFORM Pivotal Trial

NCT05147792

Atrial FibrillationStroke

View study

RECRUITINGNA

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

NCT06935591

Atrial Fibrillation (AF)

View study

RECRUITINGNA

The Fourth Left Atrial Appendage Occlusion Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation

Inclusion Criteria

Exclusion Criteria

The CONFORM Pivotal Trial

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

The Fourth Left Atrial Appendage Occlusion Study

The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study

Medtronic Terminate AF Study

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia