Atrial FibrillationCEASE-AFNCT02695277
Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
A study testing AtriCure Bipolar System, Standard Endocardial Ablation with Catheter and AtriClip® PRO LAA Exclusion System in people with Atrial Fibrillation and Persistent and Longstanding Persistent Atrial Fibrillation, run by AtriCure, Inc. at 12 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Persistent and Longstanding Persistent Atrial Fibrillation
- What is being tested?
- AtriCure Bipolar System, Standard Endocardial Ablation with Catheter and AtriClip® PRO LAA Exclusion System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Nov 2015to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Germany7 sites
Cardiovascular Center Bad Neustadt
Bad Neustadt an der Saale
Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück
Bad Rothenfelde
Heart Center Leipzig
Leipzig
Klinikum Ludwigsburg
Ludwigsburg
Peter Osypka Heart Center Munich
Munich
Kliniken Sindelfingen
Sindelfingen
Sana Heart Center Stuttgart
Stuttgart
Czechia2 sites
Dr Tomáš Ostřížek
Brno
Czech Budejovice Hospital, Inc.
České Budějovice
About this study
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.
- Being tested
- AtriCure Bipolar System, Standard Endocardial Ablation with Catheter, AtriClip® PRO LAA Exclusion System, Endocardial Ablation with Catheter, Repeated Endocardial ablation(s)
- Keywords
- Atrial Fibrillation, Persistent and Longstanding Persistent AF, Hybrid Procedure, Catheter Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtriCure Bipolar SystemDevice
Standard Endocardial Ablation with CatheterDevice
AtriClip® PRO LAA Exclusion SystemDevice
Endocardial Ablation with CatheterDevice
Repeated Endocardial ablation(s)Device
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Procedure | Experimental | Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure. Receives: Device: AtriCure Bipolar System; Device: AtriClip® PRO LAA Exclusion System; Device: Endocardial Ablation with Catheter |
| Catheter Procedure | Active comparator | 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 Receives: Device: Standard Endocardial Ablation with Catheter; Device: Repeated Endocardial ablation(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)
Secondary outcomes (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.
Measured: Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2022
- Study completionSep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardialysis BV
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695277
- Sponsor's protocol ID
- CP2015-1
- Acronym
- CEASE-AF
- Status last verified
- Sep 2024
- First submitted
- 14 Dec 2015
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Doll N, Weimar T, Kosior DA, Bulava A, Mokracek A, Monnig G, Sahu J, Hunter S, Wijffels M, van Putte B, Rub N, Nemec P, Ostrizek T, Fransen E, Suwalski P. Durable effectiveness and safety of hybrid ablation versus catheter ablation: 2-year results from the randomized CEASE-AF trialdagger. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf146. doi: 10.1093/ejcts/ezaf146.
PubMed 40711852
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02695277
- Acronym / sponsor ID
- CEASE-AF / CP2015-1
- Keywords
- Atrial Fibrillation, Persistent and Longstanding Persistent AF, Hybrid Procedure, Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cardialysis BV
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Procedure | Experimental | Device: AtriCure Bipolar System, Device: AtriClip® PRO LAA Exclusion System, Device: Endocardial Ablation with CatheterEndoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure. |
| Catheter Procedure | Active comparator | Device: Standard Endocardial Ablation with Catheter, Device: Repeated Endocardial ablation(s)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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtriCure Bipolar System | Device | Hybrid Procedure |
| Standard Endocardial Ablation with Catheter | Device | Catheter Procedure |
| AtriClip® PRO LAA Exclusion System | Device | Hybrid Procedure |
| Endocardial Ablation with Catheter | Device | Hybrid Procedure |
| Repeated Endocardial ablation(s) | Device | Catheter Procedure |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40711852Doll N, Weimar T, Kosior DA, Bulava A, Mokracek A, Monnig G, Sahu J, Hunter S, Wijffels M, van Putte B, Rub N, Nemec P, Ostrizek T, Fransen E, Suwalski P. Durable effectiveness and safety of hybrid ablation versus catheter ablation: 2-year results from the randomized CEASE-AF trialdagger. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf146. doi: 10.1093/ejcts/ezaf146.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AtriCure Bipolar System, Standard Endocardial Ablation with Catheter and AtriClip® PRO LAA Exclusion System in people with Atrial Fibrillation and Persistent and Longstanding Persistent Atrial Fibrillation, run by AtriCure, Inc. at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Czechia, Netherlands, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02695277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.