NCT Number: NCT02695277
Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
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.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Dr Tomáš Ostřížek, Brno, Czechia
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
- Patient with persistent AF and a LA-diameter ≤ 4cm
- AF is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
- Patient underwent previous ablation procedure or heart surgery
- Patient needs other cardiac surgery procedures besides AF treatment (valve, coronary, others)
- 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)
- Body mass index > 35
- LA Diameter > 6 cm
- Left ventricular ejection fraction < 30 %
- Severe mitral regurgitation (>II)
- Patient unable to undergo TransEsophageal Echocardiogram (TEE)
- 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
Treatment and study plan
Standard Endocardial Ablation with Catheter
DeviceAtriClip® PRO LAA Exclusion System
DeviceEndocardial Ablation with Catheter
DeviceRepeated Endocardial ablation(s)
DevicePrimary outcomes
-
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 outcomes
-
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 outcomes
-
Composite major complications
Time frame: Up to 180 days (6-months) post index procedure
Sponsors and collaborators
Lead sponsor
AtriCure, Inc.
Industry
Collaborators
- Cardialysis BV
Registry information
Acronym: CEASE-AF
Important dates
- Study start
- 2015
- Primary completion
- 2022
- Study completion
- 2024
- First posted
- Mar 1, 2016
- Registry last updated
- Oct 15, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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