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Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation (CEASE-AF)

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ClinicalTrials.gov Identifier: NCT02695277
Recruitment Status : Recruiting
First Posted : March 1, 2016
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Cardialysis BV
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Persistent and Longstanding Persistent Atrial Fibrillation Device: 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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
Actual Study Start Date : November 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. 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). [ Time Frame: Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure) ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure) ]

Other Outcome Measures:
  1. Composite major complications [ Time Frame: Up to 180 days (6-months) post index procedure ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695277


Contacts
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Contact: Erik Fransen, MSc, PhD efransen@atricure.com
Contact: Nfii Ndikintum, PhD, MBA nndikintum@atricure.com

Locations
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Czechia
Dr Tomáš Ostřížek Recruiting
Brno, Czechia
Czech Budejovice Hospital, Inc. Recruiting
Budweis, Czechia
Germany
Cardiovascular Center Bad Neustadt Recruiting
Bad Neustadt An Der Saale, Germany
Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück Recruiting
Bad Rothenfelde, Germany
Heart Center Leipzig Recruiting
Leipzig, Germany
Contact: Surgeon: Prof. Dr. Martin Misfeld         
Contact: Electrophysiologist: Prof. Dr. Gerhard Hindricks         
Klinikum Ludwigsburg Recruiting
Ludwigsburg, Germany
Peter Osypka Heart Center Munich Active, not recruiting
Munich, Germany
Kliniken Sindelfingen Active, not recruiting
Sindelfingen, Germany
Sana Heart Center Stuttgart Recruiting
Stuttgart, Germany
Contact: Prof. Dr. Kai-Nicolas Doll         
Netherlands
St. Antonius Hospital Recruiting
Nieuwegein, Netherlands
Contact: Surgeon: Dr. Bart van Putte         
Contact: Electrophysiologist: Dr. Maurits Wijffels         
Poland
Central Clinical Hospital of the Ministry of Interior Recruiting
Warsaw, Poland
United Kingdom
Northern General Hospital Recruiting
Sheffield, United Kingdom
Sponsors and Collaborators
AtriCure, Inc.
Cardialysis BV

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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT02695277     History of Changes
Other Study ID Numbers: CP2015-1
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Keywords provided by AtriCure, Inc.:
Atrial Fibrillation
Persistent and Longstanding Persistent AF
Hybrid Procedure
Catheter Ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes