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

Not Applicable

Completed

• Conditions: Persistent and Longstanding Persistent Atrial Fibrillation; Atrial Fibrillation
• Interventions: Device: AtriCure Bipolar System; Device: Standard Endocardial Ablation with Catheter; Device: AtriClip® PRO LAA Exclusion System; Device: Repeated Endocardial ablation(s); Device: Endocardial Ablation with Catheter

• Registration Number: NCT02695277
• Lead Sponsor: AtriCure, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-03-01
• Primary Completion: 2022-11
• Status Verified: 2024-09
• Study Completion: 2024-09
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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 %
11. Severe mitral regurgitation (>II)
12. Patient unable to undergo TransEsophageal Echocardiogram (TEE)
13. Presence of LA thrombus by TEE, CT scan, MRI or angiography
14. History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
15. Active infection or sepsis
16. Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis)
17. Contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
18. Pregnancy, planned pregnancy or breastfeeding
19. Life expectancy is less than 12 months
20. Patient is involved in another study involving an investigational drug or device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid Procedure	AtriClip® PRO LAA Exclusion System	Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure.
Catheter Procedure	Repeated Endocardial ablation(s)	Standard catheter ablation with pulmonary vein (PV) isolation (minimum lesion set) and optional additional lesions (index procedure). When required due to AF recurrence, ablation may be repeated within 6 months after the index-procedure according to clinical indications and consistent with the Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Consensus Statement
Hybrid Procedure	AtriCure Bipolar System	Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure.
Hybrid Procedure	Endocardial Ablation with Catheter	Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure.
Catheter Procedure	Standard Endocardial Ablation with Catheter	Standard catheter ablation with pulmonary vein (PV) isolation (minimum lesion set) and optional additional lesions (index procedure). When required due to AF recurrence, ablation may be repeated within 6 months after the index-procedure according to clinical indications and consistent with the Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Consensus Statement

Primary Outcome Measures

Name	Time	Method
Number of subjects free from documented Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) episodes > 30 seconds in duration through 12 months follow-up, in the absence of Class I or III Antiarrhythmic Drugs (AADs).	Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)

Secondary Outcome Measures

Name	Time	Method
Number of subjects free from documented AF, AFL or AT episodes > 30 seconds in duration through 24 and 36 months follow-up, in the absence of Class I or III AADs.	Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)

Trial Locations

Locations (12)

Dr Tomáš Ostřížek; 🇨🇿 Brno, Czechia

Czech Budejovice Hospital, Inc.; 🇨🇿 Budweis, Czechia

Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück; 🇩🇪 Bad Rothenfelde, Germany

Heart Center Leipzig; 🇩🇪 Leipzig, Germany

Cardiovascular Center Bad Neustadt; 🇩🇪 Bad Neustadt An Der Saale, 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

Central Clinical Hospital of the Ministry of Interior; 🇵🇱 Warsaw, Poland

Northern General Hospital; 🇬🇧 Sheffield, United Kingdom