Treatment of Atrial Fibrillation by Minimal Invasive Surgery

Atrial Fibrillation Clinical Trial

— ABOLISH-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448656
• Other study ID #: p06.0550l
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2007
• Last updated: June 18, 2012
• Start date: June 2006
• Est. completion date: December 2008

Study information

• Verified date: June 2012
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

Inclusion Criteria:

1. Documented symptomatic lone paroxysmal or persistent atrial fibrillation, which either convert spontaneously or can be terminated with antiarrhythmic drugs or by an electrical cardioversion.

2. The patient had a least one episode of persistent atrial fibrillation or three episodes of paroxysmal atrial fibrillation during the last three months.

3. Duration present episode persistent atrial fibrillation less then one year.

4. 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.

5. The patient will sign and date the written informed consent prior to study participation.

Exclusion Criteria:

1. Age <18 and >76 years.

2. Contraindications for oral anticoagulation.

3. 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).

4. Permanent atrial fibrillation defined as atrial fibrillation continuously present and not convertible to sinus rhythm by an electrical cardioversion or antiarrhythmic drugs.

5. Previous transvenous pulmonary vein isolation, Maze surgery, or other cardiac surgery.

6. Heart failure defined as NYHA class III-IV heart failure.

7. Previously implanted intracardiac device or has current or foreseen pacemaker, internal cardioverter defibrillator (ICD) and/ or cardiac resynchronization therapy.

8. Clinically relevant valvular heart disease.

9. Coronary artery disease or an old myocardial infarction

10. Acute or chronic infection.

11. Untreated clinical hypo- or hyperthyroidism or < 3 months euthyroidism.

12. 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).

13. 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• ablation of pulmonary veins by video assisted thoracic surgery
epicardial ablation using HIFU

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sinus rhythm at end of follow-up (6 months)		6 months	No
Secondary	absence of permanent atrial fibrillation at end of follow-up		6 months	No
Secondary	absence of any symptomatic atrial fibrillation		6 months	No
Secondary	atrial volume and contraction at end of follow-up		6 months	No
Secondary	left ventricular diameters and function at end of follow-up		6 months	No
Secondary	thromboembolism		6 months	Yes
Secondary	pulmonary vein stenosis		6 months	Yes
Secondary	immediate postoperative complications (and related sequelae)		directly post-operative	Yes
Secondary	surgical procedure time and total epicardial ablation time		directly post-operative	No
Secondary	any pacemaker implantation		6 months	Yes
Secondary	mortality		6 months	Yes
Secondary	bleeding		6 months	Yes
Secondary	hospitalization for heart failure		6 months	No
Secondary	antiarrhythmic drugs during follow-up		6 months	No
Secondary	electrical cardioversions during follow-up		6 months	No
Secondary	re-ablations		6 months	No
Secondary	syncope		6 months	No
Secondary	quality of life and specific arrhythmia symptoms		6 months	No