NCT00184249

Brief Summary

The study is a prospective multi-centre study to investigate the effect of a new bipolar ablation strategy of the left atrium in patients with paroxysmal or permanent atrial fibrillation over time.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable atrial-fibrillation

Status
withdrawn

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, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

5 years

First QC Date

September 13, 2005

Last Update Submit

March 18, 2015

Conditions

Atrial Fibrillation

Keywords

Catheter ablationHeart/surgeryCardial surgical procedures

Outcome Measures

Primary Outcomes (3)

  • Number of patients in sinus rhythm after 3, 6, and 12 months

    3, 6,

  • Number of patients with atrial function at echo-doppler after 6 and 12 months

    3,6, 12 months

  • Number of patients on anticoagulants after 6 and 12 months

    6 and 12 months

Study Arms (1)

Bipolar radiofrequency ablation

EXPERIMENTAL
Procedure: Bipolar radiofrequency ablation

Interventions

Bipolar radiofrequency ablationPROCEDURE

Ablation using CE marked bipolar ablation devices

Also known as: Cardioblade, Atricure
Bipolar radiofrequency ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • referred for elective heart surgery with extracorporeal circulation
  • suffers from AF for more than 6 months but less than 7 years
  • aged between 18 and 80 years
  • ejection fraction above 30 %

You may not qualify if:

  • Reoperations
  • NYHA class IV
  • Ischemic mitral incompetence
  • Creatinine \> 140
  • Transmural myocardial infarction \< 4 weeks
  • Endocarditis
  • Serious peripheral vascular disease
  • Pregnancy or breast-feeding
  • Drug addiction
  • Size of left atrium \> 60 mm in preoperative echo-doppler investigation.
  • Disease or other condition when the patient is unable to understand the objectives and the scope of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Wahba, Prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2012

Last Updated

March 20, 2015

Record last verified: 2015-03