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OpenTrials
Completed

NCT Number: NCT00448656

Treatment of Atrial Fibrillation by Minimal Invasive Surgery

The purpose of this study is to determine the feasability of a new epicardial and minimal invasive ablation technique of the left atrium isolating the pulmonary veins for prevention of atrial fibrillation recurrences in patients with antiarrhythmic drug refractory lone atrial fibrillation.

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Key information

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

About this study

Atrial fibrillation is a major health problem.Despite adequate treatment of underlying heart disease, rhythm control is unsuccessful in almost half of patients, also in patients with lone atrial fibrillation.If patients remain highly symptomatic, a non-pharmacological approach may be considered including pulmonary vein isolation and Cox maze III surgery. Maze III surgery has high succes rates, however it includes major cardiac surgery with substantial risk of complications. New surgical strategies for symptomatic lone atrial fibrillation focus on minimal invasive off-pump procedures omitting cardiopulmonary bypass (and thus lowering the complication rate), while taking advantage of an easier approach to the ablation site and a shorter procedure time. Epicardial surgical ablation isolating pulmonary veins by high intensity focused ultrasound performed off-pump by Video Assisted Thoracic Surgery (VATS)may be a promising treatment option. In this pilot study, we aim to study the feasibility of this new surgical ablation approach in patients with lone atrial fibrillation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented symptomatic lone paroxysmal or persistent atrial fibrillation, which either convert spontaneously or can be terminated with antiarrhythmic drugs or by an electrical cardioversion.
  • The patient had a least one episode of persistent atrial fibrillation or three episodes of paroxysmal atrial fibrillation during the last three months.
  • Duration present episode persistent atrial fibrillation less then one year.
  • The patient has been treated with at least two different antiarrhythmic drugs (class I-IV) of which at least one belongs to class I or III.
  • The patient will sign and date the written informed consent prior to study participation.

Exclusion criteria

  • Age <18 and >76 years.
  • Contraindications for oral anticoagulation.
  • Signs of sick sinus syndrome or AV conduction disturbances (i.e. symptomatic bradycardia or asystole > 3 seconds or escape rate < 40 beats per minute in awake symptom-free patients).
  • Permanent atrial fibrillation defined as atrial fibrillation continuously present and not convertible to sinus rhythm by an electrical cardioversion or antiarrhythmic drugs.
  • Previous transvenous pulmonary vein isolation, Maze surgery, or other cardiac surgery.
  • Heart failure defined as NYHA class III-IV heart failure.
  • Previously implanted intracardiac device or has current or foreseen pacemaker, internal cardioverter defibrillator (ICD) and/ or cardiac resynchronization therapy.
  • Clinically relevant valvular heart disease.
  • Coronary artery disease or an old myocardial infarction
  • Acute or chronic infection.
  • Untreated clinical hypo- or hyperthyroidism or < 3 months euthyroidism.
  • Uncontrolled hypertension, defined as a systolic blood pressure > 160 mm Hg and/or a diastolic blood pressure > 95 mm Hg (anti-hypertensive treatment is allowed).
  • The patient has a concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extracardiac disease) or is unlikely to comply with the protocol.

Treatment and study plan

ablation of pulmonary veins by video assisted thoracic surgery

Procedure

epicardial ablation using HIFU

Other names: Epicor

Primary outcomes

  1. sinus rhythm at end of follow-up (6 months)

    Time frame: 6 months

Secondary outcomes

  1. absence of permanent atrial fibrillation at end of follow-up

    Time frame: 6 months

  2. absence of any symptomatic atrial fibrillation

    Time frame: 6 months

  3. atrial volume and contraction at end of follow-up

    Time frame: 6 months

  4. left ventricular diameters and function at end of follow-up

    Time frame: 6 months

  5. thromboembolism

    Time frame: 6 months

  6. pulmonary vein stenosis

    Time frame: 6 months

  7. immediate postoperative complications (and related sequelae)

    Time frame: directly post-operative

  8. surgical procedure time and total epicardial ablation time

    Time frame: directly post-operative

  9. any pacemaker implantation

    Time frame: 6 months

  10. mortality

    Time frame: 6 months

  11. bleeding

    Time frame: 6 months

  12. hospitalization for heart failure

    Time frame: 6 months

  13. antiarrhythmic drugs during follow-up

    Time frame: 6 months

  14. electrical cardioversions during follow-up

    Time frame: 6 months

  15. re-ablations

    Time frame: 6 months

  16. syncope

    Time frame: 6 months

  17. quality of life and specific arrhythmia symptoms

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Treatment of Atrial Fibrillation by Minimal Invasive Epicardial Pulmonary Vein Isolation: The ABOLISH-AF Study

Acronym: ABOLISH-AF

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 19, 2007
Registry last updated
Jun 19, 2012

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.

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