CEASE-AF: Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hybrid Procedure Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure. |
Device: AtriCure Bipolar System
Device: AtriClip® PRO LAA Exclusion System
Device: Endocardial Ablation with Catheter
|
| Active Comparator: 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 |
Device: Standard Endocardial Ablation with Catheter
Device: Repeated Endocardial ablation(s)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)]
Other Outcome Measures
- Composite major complications [Up to 180 days (6-months) post index procedure]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
-
Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)
-
Patient is mentally able and willing to give informed consent
Exclusion Criteria:
-
Patient has longstanding persistent AF > 10 years
-
Patient presenting with paroxysmal AF
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Patient with persistent AF and a LA-diameter ≤ 4cm
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AF is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
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Patient underwent previous ablation procedure or heart surgery
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Patient needs other cardiac surgery procedures besides AF treatment (valve, coronary, others)
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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)
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Body mass index > 35
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LA Diameter > 6 cm
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Left ventricular ejection fraction < 30 %
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Severe mitral regurgitation (>II)
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Patient unable to undergo TransEsophageal Echocardiogram (TEE)
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Presence of LA thrombus by TEE, CT scan, MRI or angiography
-
History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
-
Active infection or sepsis
-
Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis)
-
Contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
-
Pregnancy, planned pregnancy or breastfeeding
-
Life expectancy is less than 12 months
-
Patient is involved in another study involving an investigational drug or device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr Tomáš Ostřížek | Brno | Czechia | ||
| 2 | Czech Budejovice Hospital, Inc. | Budweis | Czechia | ||
| 3 | Cardiovascular Center Bad Neustadt | Bad Neustadt An Der Saale | Germany | ||
| 4 | Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück | Bad Rothenfelde | Germany | ||
| 5 | Heart Center Leipzig | Leipzig | Germany | ||
| 6 | Klinikum Ludwigsburg | Ludwigsburg | Germany | ||
| 7 | Peter Osypka Heart Center Munich | Munich | Germany | ||
| 8 | Kliniken Sindelfingen | Sindelfingen | Germany | ||
| 9 | Sana Heart Center Stuttgart | Stuttgart | Germany | ||
| 10 | St. Antonius Hospital | Nieuwegein | Netherlands | ||
| 11 | Central Clinical Hospital of the Ministry of Interior | Warsaw | Poland | ||
| 12 | Northern General Hospital | Sheffield | United Kingdom |
Sponsors and Collaborators
- AtriCure, Inc.
- Cardialysis BV
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP2015-1