NCT00448656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 atrial-fibrillation

Timeline
Completed

Started Jun 2006

Typical duration for phase_2 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

2.5 years

First QC Date

March 15, 2007

Last Update Submit

June 18, 2012

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationepicardial ablation pulmonary veinsvideo assisted thoracic surgery

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (17)

  • absence of permanent atrial fibrillation at end of follow-up

    6 months

  • absence of any symptomatic atrial fibrillation

    6 months

  • atrial volume and contraction at end of follow-up

    6 months

  • left ventricular diameters and function at end of follow-up

    6 months

  • thromboembolism

    6 months

  • +12 more secondary outcomes

Interventions

ablation of pulmonary veins by video assisted thoracic surgeryPROCEDURE

epicardial ablation using HIFU

Also known as: Epicor

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 19812047DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Isabelle C. Vam Gelder, MD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.dr.

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 19, 2007

Study Start

June 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

NL(1)