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

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AtriCure

Status

Active, not recruiting

Conditions

Atrial Fibrillation
Persistent and Longstanding Persistent Atrial Fibrillation

Treatments

Device: AtriClip® PRO LAA Exclusion System
Device: Endocardial Ablation with Catheter
Device: Standard Endocardial Ablation with Catheter
Device: Repeated Endocardial ablation(s)
Device: AtriCure Bipolar System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02695277
CP2015-1

Details and patient eligibility

About

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.

Enrollment

146 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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 %
  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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

146 participants in 2 patient groups

Hybrid Procedure
Experimental group
Description:
Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure.
Treatment:
Device: AtriCure Bipolar System
Device: Endocardial Ablation with Catheter
Device: AtriClip® PRO LAA Exclusion System
Catheter Procedure
Active Comparator group
Description:
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
Treatment:
Device: Repeated Endocardial ablation(s)
Device: Standard Endocardial Ablation with Catheter

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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