NCT02695277

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
5 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 15, 2024

Status Verified

September 1, 2024

Enrollment Period

7 years

First QC Date

December 14, 2015

Last Update Submit

October 10, 2024

Conditions

Atrial FibrillationPersistent and Longstanding Persistent Atrial Fibrillation

Keywords

Atrial FibrillationPersistent and Longstanding Persistent AFHybrid ProcedureCatheter Ablation

Outcome Measures

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).

    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.

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

Other Outcomes (1)

  • Composite major complications

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

Study Arms (2)

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.

Device: AtriCure Bipolar SystemDevice: AtriClip® PRO LAA Exclusion SystemDevice: 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

Device: Standard Endocardial Ablation with CatheterDevice: Repeated Endocardial ablation(s)

Interventions

AtriCure Bipolar SystemDEVICE
Hybrid Procedure
Standard Endocardial Ablation with CatheterDEVICE
Catheter Procedure
AtriClip® PRO LAA Exclusion SystemDEVICE
Hybrid Procedure
Endocardial Ablation with CatheterDEVICE
Hybrid Procedure
Repeated Endocardial ablation(s)DEVICE
Catheter Procedure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Dr Tomáš Ostřížek

Brno, Czechia

Location

Czech Budejovice Hospital, Inc.

České Budějovice, Czechia

Location

Cardiovascular Center Bad Neustadt

Bad Neustadt an der Saale, Germany

Location

Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück

Bad Rothenfelde, Germany

Location

Heart Center Leipzig

Leipzig, Germany

Location

Klinikum Ludwigsburg

Ludwigsburg, Germany

Location

Peter Osypka Heart Center Munich

Munich, Germany

Location

Kliniken Sindelfingen

Sindelfingen, Germany

Location

Sana Heart Center Stuttgart

Stuttgart, Germany

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Central Clinical Hospital of the Ministry of Interior

Warsaw, Poland

Location

Northern General Hospital

Sheffield, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 40711852DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheters

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2015

First Posted

March 1, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2022

Study Completion

September 1, 2024

Last Updated

October 15, 2024

Record last verified: 2024-09

Locations

GB(1)PL(1)DE(7)CZ(2)NL(1)