Back to resultsCombined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation (CEASE-AF)
Primary Purpose
Atrial Fibrillation, Persistent and Longstanding Persistent Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AtriCure Bipolar System
Standard Endocardial Ablation with Catheter
AtriClip® PRO LAA Exclusion System
Endocardial Ablation with Catheter
Repeated Endocardial ablation(s)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Persistent and Longstanding Persistent AF, Hybrid Procedure, Catheter Ablation
Eligibility 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
- 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
Sites / Locations
- Dr Tomáš Ostřížek
- Czech Budejovice Hospital, Inc.
- Cardiovascular Center Bad Neustadt
- Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück
- Heart Center Leipzig
- Klinikum Ludwigsburg
- Peter Osypka Heart Center Munich
- Kliniken Sindelfingen
- Sana Heart Center Stuttgart
- St. Antonius Hospital
- Central Clinical Hospital of the Ministry of Interior
- Northern General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hybrid Procedure
Catheter Procedure
Arm Description
Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index 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
Outcomes
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).
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.
Full Information
NCT ID
NCT02695277
First Posted
December 14, 2015
Last Updated
January 31, 2023
Sponsor
AtriCure, Inc.
Collaborators
Cardialysis BV
1. Study Identification
Unique Protocol Identification Number
NCT02695277
Brief Title
Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
Acronym
CEASE-AF
Official Title
Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 2022 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.
Collaborators
Cardialysis BV
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Persistent and Longstanding Persistent Atrial Fibrillation
Keywords
Atrial Fibrillation, Persistent and Longstanding Persistent AF, Hybrid Procedure, Catheter Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hybrid Procedure
Arm Type
Experimental
Arm Description
Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure.
Arm Title
Catheter Procedure
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
AtriCure Bipolar System
Intervention Type
Device
Intervention Name(s)
Standard Endocardial Ablation with Catheter
Intervention Type
Device
Intervention Name(s)
AtriClip® PRO LAA Exclusion System
Intervention Type
Device
Intervention Name(s)
Endocardial Ablation with Catheter
Intervention Type
Device
Intervention Name(s)
Repeated Endocardial ablation(s)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Composite major complications
Time Frame
Up to 180 days (6-months) post index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Facility Information:
Facility Name
Dr Tomáš Ostřížek
City
Brno
Country
Czechia
Facility Name
Czech Budejovice Hospital, Inc.
City
Budweis
Country
Czechia
Facility Name
Cardiovascular Center Bad Neustadt
City
Bad Neustadt An Der Saale
Country
Germany
Facility Name
Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück
City
Bad Rothenfelde
Country
Germany
Facility Name
Heart Center Leipzig
City
Leipzig
Country
Germany
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
Country
Germany
Facility Name
Peter Osypka Heart Center Munich
City
Munich
Country
Germany
Facility Name
Kliniken Sindelfingen
City
Sindelfingen
Country
Germany
Facility Name
Sana Heart Center Stuttgart
City
Stuttgart
Country
Germany
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands
Facility Name
Central Clinical Hospital of the Ministry of Interior
City
Warsaw
Country
Poland
Facility Name
Northern General Hospital
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
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