Treatment of Atrial Fibrillation by Minimal Invasive Surgery - Full Text View

Sponsored by:	University Medical Centre Groningen
Information provided by:	University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00448656

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Procedure: ablation of pulmonary veins by video assisted thoracic surgery	Phase II

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment of Atrial Fibrillation by Minimal Invasive Epicardial Pulmonary Vein Isolation: The ABOLISH-AF Study

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:

sinus rhythm at end of follow-up (6 months) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	15
Study Start Date:	June 2006
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

epicardial ablation using HIFU

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 76 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448656

Locations

Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB

Sponsors and Collaborators

University Medical Centre Groningen

Investigators

Principal Investigator:

Isabelle C. Vam Gelder, MD

University Medical Centre Groningen

More Information

Responsible Party:	University Medical Center Groningen ( prof I.C. Van Gelder )
Study ID Numbers:	p06.0550l
Study First Received:	March 15, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00448656
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:

atrial fibrillation
epicardial ablation pulmonary veins
video assisted thoracic surgery

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009