Back to resultsTreatment of Atrial Fibrillation by Minimal Invasive Surgery (ABOLISH-AF)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
ablation of pulmonary veins by video assisted thoracic surgery
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, epicardial ablation pulmonary veins, video assisted thoracic surgery
Eligibility 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.
Sites / Locations
- University Medical Center Groningen
Outcomes
Primary Outcome Measures
sinus rhythm at end of follow-up (6 months)
Secondary Outcome Measures
absence of permanent atrial fibrillation at end of follow-up
absence of any symptomatic atrial fibrillation
atrial volume and contraction at end of follow-up
left ventricular diameters and function at end of follow-up
thromboembolism
pulmonary vein stenosis
immediate postoperative complications (and related sequelae)
surgical procedure time and total epicardial ablation time
any pacemaker implantation
mortality
bleeding
hospitalization for heart failure
antiarrhythmic drugs during follow-up
electrical cardioversions during follow-up
re-ablations
syncope
quality of life and specific arrhythmia symptoms
Full Information
NCT ID
NCT00448656
First Posted
March 15, 2007
Last Updated
June 18, 2012
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT00448656
Brief Title
Treatment of Atrial Fibrillation by Minimal Invasive Surgery
Acronym
ABOLISH-AF
Official Title
Treatment of Atrial Fibrillation by Minimal Invasive Epicardial Pulmonary Vein Isolation: The ABOLISH-AF Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, epicardial ablation pulmonary veins, video assisted thoracic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
ablation of pulmonary veins by video assisted thoracic surgery
Other Intervention Name(s)
Epicor
Intervention Description
epicardial ablation using HIFU
Primary Outcome Measure Information:
Title
sinus rhythm at end of follow-up (6 months)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
absence of permanent atrial fibrillation at end of follow-up
Time Frame
6 months
Title
absence of any symptomatic atrial fibrillation
Time Frame
6 months
Title
atrial volume and contraction at end of follow-up
Time Frame
6 months
Title
left ventricular diameters and function at end of follow-up
Time Frame
6 months
Title
thromboembolism
Time Frame
6 months
Title
pulmonary vein stenosis
Time Frame
6 months
Title
immediate postoperative complications (and related sequelae)
Time Frame
directly post-operative
Title
surgical procedure time and total epicardial ablation time
Time Frame
directly post-operative
Title
any pacemaker implantation
Time Frame
6 months
Title
mortality
Time Frame
6 months
Title
bleeding
Time Frame
6 months
Title
hospitalization for heart failure
Time Frame
6 months
Title
antiarrhythmic drugs during follow-up
Time Frame
6 months
Title
electrical cardioversions during follow-up
Time Frame
6 months
Title
re-ablations
Time Frame
6 months
Title
syncope
Time Frame
6 months
Title
quality of life and specific arrhythmia symptoms
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle C. Vam Gelder, MD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19812047
Citation
Klinkenberg TJ, Ahmed S, Ten Hagen A, Wiesfeld AC, Tan ES, Zijlstra F, Van Gelder IC. Feasibility and outcome of epicardial pulmonary vein isolation for lone atrial fibrillation using minimal invasive surgery and high intensity focused ultrasound. Europace. 2009 Dec;11(12):1624-31. doi: 10.1093/europace/eup299. Epub 2009 Oct 6.
Results Reference
derived
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Treatment of Atrial Fibrillation by Minimal Invasive Surgery
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