Skip to main content
OpenTrials
Completed

NCT Number: NCT02695277

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Tomáš Ostřížek, Brno, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AtriCure Bipolar System

Device

Standard Endocardial Ablation with Catheter

Device

AtriClip® PRO LAA Exclusion System

Device

Endocardial Ablation with Catheter

Device

Repeated Endocardial ablation(s)

Device

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

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Collaborators

  • Cardialysis BV

Registry information

Acronym: CEASE-AF

Important dates

Study start
2015
Primary completion
2022
Study completion
2024
First posted
Mar 1, 2016
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.