Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
NCT ID: NCT02695277
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2015-11-30
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hybrid Procedure
Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure.
AtriCure Bipolar System
AtriClip® PRO LAA Exclusion System
Endocardial Ablation with Catheter
Catheter Procedure
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
Standard Endocardial Ablation with Catheter
Repeated Endocardial ablation(s)
Interventions
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AtriCure Bipolar System
Standard Endocardial Ablation with Catheter
AtriClip® PRO LAA Exclusion System
Endocardial Ablation with Catheter
Repeated Endocardial ablation(s)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Cardialysis BV
INDUSTRY
AtriCure, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Central Clinical Hospital of the Ministry of Interior
Warsaw, , Poland
Northern General Hospital
Sheffield, , United Kingdom
Countries
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References
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Doll N, Weimar T, Kosior DA, Bulava A, Mokracek A, Monnig G, Sahu J, Hunter S, Wijffels M, van Putte B, Rub N, Nemec P, Ostrizek T, Fransen E, Suwalski P. Durable effectiveness and safety of hybrid ablation versus catheter ablation: 2-year results from the randomized CEASE-AF trialdagger. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf146. doi: 10.1093/ejcts/ezaf146.
Other Identifiers
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CP2015-1
Identifier Type: -
Identifier Source: org_study_id
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