ClinicalTrials.gg
Sign In
CompletedNCT02695277CEASE-AFUpdated Oct 15, 2024

Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation

An interventional study of AtriCure Bipolar System and Standard Endocardial Ablation with Catheter in Atrial Fibrillation and Persistent and Longstanding Persistent Atrial Fibrillation, sponsored by AtriCure, Inc.. Completed at 12 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by AtriCure, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation
  • Persistent and Longstanding Persistent Atrial Fibrillation

Browse trials for

Keywords

  • Atrial Fibrillation
  • Persistent and Longstanding Persistent AF
  • Hybrid Procedure
  • Catheter Ablation
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 146 is close to the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

AtriCure, Inc. is the lead sponsor of 32 studies on the registry; 5 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Browse AtriCure, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
146 participants (actual)

Study arms

  • 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)

Interventions

  • DeviceAtriCure Bipolar System
  • DeviceStandard Endocardial Ablation with Catheter
  • DeviceAtriClip® PRO LAA Exclusion System
  • DeviceEndocardial Ablation with Catheter
  • DeviceRepeated Endocardial ablation(s)
06

What researchers measure

Primary outcomes

  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 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.

    Time frame: Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)

Other outcomes

  1. Composite major complications

    Time frame: Up to 180 days (6-months) post index procedure

07

Study locations

12 sites
  • Dr Tomáš Ostřížek
    Brno, Czechia
  • Czech Budejovice Hospital, Inc.
    České Budějovice, Czechia
  • Cardiovascular Center Bad Neustadt
    Bad Neustadt an der Saale, Germany
  • Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück
    Bad Rothenfelde, Germany
  • Heart Center Leipzig
    Leipzig, Germany
  • Klinikum Ludwigsburg
    Ludwigsburg, Germany
  • Peter Osypka Heart Center Munich
    Munich, Germany
  • Kliniken Sindelfingen
    Sindelfingen, Germany
  • Sana Heart Center Stuttgart
    Stuttgart, Germany
  • St. Antonius Hospital
    Nieuwegein, Netherlands
  • Central Clinical Hospital of the Ministry of Interior
    Warsaw, Poland
  • Northern General Hospital
    Sheffield, United Kingdom
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2015 to primary completion in Nov 2022, 84 months.

Of 242 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 84 months is above that.

Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2015
First posted
Mar 1, 2016
StartActual
Nov 2015
Primary completionActual
Nov 2022
CompletionActual
Sep 2024
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02695277
Lead sponsor
AtriCure, Inc.
Collaborators
Cardialysis BV
Responsible party
Sponsor
First posted
Mar 1, 2016
Start date
Nov 2015
Primary completion
Nov 2022
Completion
Sep 2024
Last update
Oct 15, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Atrial Fibrillation →

Other studies from this sponsor

AtriCure, Inc. →

Start the discussion