NCT01019759

Brief Summary

The hypothesis being studied is that add-on arrhythmia surgery in patients with atrial fibrillation (AF) undergoing valvular or coronary surgery improves quality of life, is cost-effective, reduces perioperative and long-term morbidity associated with AF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2002

Typical duration for not_applicable 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

September 1, 2002

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2009

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

4.2 years

First QC Date

July 6, 2009

Last Update Submit

November 23, 2009

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationcardiac surgeryablationpulmonary veins

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients free from atrial fibrillation, as apparent from 24 hour Holter registration, in addition to standard ECG. For the purpose of this primary endpoint, AF was defined as lasting longer than 10 seconds.

    between 3 months and 12 months post-operative

Secondary Outcomes (6)

  • Quality of life (QoL)

    at 3, 6 and12 months post-operative

  • Cost-effectiveness

    intraoperative untill 12 months post-operative

  • In-hospital morbidity (incl. pulmonary complications, resternotomy for surgical bleeding, cerebrovascular accidents, acute myocardial infarction, renal failure, development of atrioventricular conduction abnormalities)

    post-operative, in-hospital period

  • Rhythm related events and interventions (incl. electrical or chemical cardioversion, percutaneous catheter ablation, implantation of a defibrillator, pacemaker implantation)

    discharge untill 12 months post-operative

  • Out-of-hospital morbidity (incl. acute myocardial infarction, percutaneous catheter ablation, implantation of a defibrillator, pacemaker implantation and cerebrovascular accidents, syncope)

    discharge untill 12 months post-operative

  • +1 more secondary outcomes

Study Arms (2)

No add-on AF-surgery

NO INTERVENTION

patient undergoing only scheduled valve and/or coronary bypass surgery

PV isolation

EXPERIMENTAL

patient undergoing add-on epicardial microwave energy pulmonary vein isolation

Procedure: pulmonary vein isolation

Interventions

pulmonary vein isolationPROCEDURE

The off-pump beating heart ablation procedure is performed. Using a Microwave (MW) energy ablation tool (Microwave generator by Guidant), epicardial ablation line isolating the pulmonary veins are applied during open heart surgery

Also known as: Microwave generator by Guidant, Flex 4 or Flex 10 ablation probes by Guidant
PV isolation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergo valvular surgery, coronary surgery, or a combination of both.
  • All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
  • Patients have given written informed consent.

You may not qualify if:

  • Patients who do not speak Dutch or can not read Dutch.
  • Patients with a Sick Sinus Syndrome.
  • Patients with contraindications for oral anticoagulant agents.
  • Patients unable to express their specific wishes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jos G Maessen,, MD, PhD

    dept. Cardiothoracic Surgery, University hospital of Maastricht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2009

First Posted

November 25, 2009

Study Start

September 1, 2002

Primary Completion

November 1, 2006

Study Completion

December 1, 2006

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

NL(1)