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

July 26, 2022 updated by: AtriCure, Inc.
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Composite major complications
Time Frame: Up to 180 days (6-months) post index procedure
Up to 180 days (6-months) post index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AtriCure, Inc.

Collaborators

Cardialysis BV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP2015-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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