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Atrial FibrillationPhase 2ABOLISH-AFNCT00448656

Treatment of Atrial Fibrillation by Minimal Invasive Surgery

A Phase 2 study testing ablation of pulmonary veins by video assisted thoracic surgery in people with Atrial Fibrillation, run by University Medical Center Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 76 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
ablation of pulmonary veins by video assisted thoracic surgery
Type of treatment
Surgery or procedure
How many people
15 participants
Where
1 siteNetherlands
Study dates
Jun 2006to Dec 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 76 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9700 RB

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
ablation of pulmonary veins by video assisted thoracic surgery
Keywords
atrial fibrillation, epicardial ablation pulmonary veins, video assisted thoracic surgery
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ablation of pulmonary veins by video assisted thoracic surgeryProcedure or surgery

    Also called Epicor

    epicardial ablation using HIFU

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (17)

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

    Measured: 6 months

  2. absence of any symptomatic atrial fibrillation

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  5. thromboembolism

    Measured: 6 months

  6. pulmonary vein stenosis

    Measured: 6 months

  7. immediate postoperative complications (and related sequelae)

    Measured: directly post-operative

  8. surgical procedure time and total epicardial ablation time

    Measured: directly post-operative

  9. any pacemaker implantation

    Measured: 6 months

  10. mortality

    Measured: 6 months

  11. bleeding

    Measured: 6 months

  12. hospitalization for heart failure

    Measured: 6 months

  13. antiarrhythmic drugs during follow-up

    Measured: 6 months

  14. electrical cardioversions during follow-up

    Measured: 6 months

  15. re-ablations

    Measured: 6 months

  16. syncope

    Measured: 6 months

  17. quality of life and specific arrhythmia symptoms

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2007 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00448656
Sponsor's protocol ID
p06.0550l
Acronym
ABOLISH-AF
Status last verified
Jun 2012
First submitted
15 Mar 2007
Last updated
19 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19812047

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ablation of pulmonary veins by video assisted thoracic surgery in people with Atrial Fibrillation, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sinus rhythm at end of follow-up (6 months) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00448656, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.

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