A Prospective Multi Centre Trial on Bipolar Radiofrequency Ablation of Atrial Fibrillation

This study has been withdrawn prior to enrollment.
(collabortors did not enter patients into the study. Therefore the study was stopped.)
Sponsor:
Collaborators:
St. Olavs Hospital
Oslo University Hospital
Haukeland Sykehus HF
Ullevaal University Hospital
Regionssykehuset i Tromsø HF
Feiringklinikken
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184249
First received: September 13, 2005
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: Bipolar radiofrequency ablation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multi Centre Trial on Bipolar Radiofrequency Ablation of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Number of patients in sinus rhythm after 3, 6, and 12 months [ Time Frame: 3, 6, ] [ Designated as safety issue: No ]
  • Number of patients with atrial function at echo-doppler after 6 and 12 months [ Time Frame: 3,6, 12 months ] [ Designated as safety issue: No ]
  • Number of patients on anticoagulants after 6 and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2005
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Bipolar radiofrequency ablation
    Ablation using CE marked bipolar ablation devices
    Other Names:
    • Cardioblade
    • Atricure
Detailed Description:

Atrial fibrillation (AF) is the most common persistent arrhythmia, prevalent in about 6% of the population over 65 years of age. AF reduces the quality of life and increases mortality. AF is particularly common in combination with mitral valve disease, but is also detected in about 5% of patients with aortic valve and coronary artery disease. Surgical treatment of AF with the Cox-maze III operation was developed by J. Cox during the 80ies. The aim of the operation is to block spread of irregular electrical activity by creating lines of isolation in the atrial musculature. The operation achieves sinus rhythm in over 90% in selected patients. Nevertheless the method was only used in few heart surgical centres, because it is complex and time consuming.In recent years alternative energy sources have been developed to create isolating lines without cutting the tissue and thus making ablation treatment easier. Bipolar radiofrequency ablation is special because the energy is delivered feedback controlled until transmurality is achieved. This is a prerequisite for a good result and makes using the equipment safer.

Since the development of the Cox-maze procedure, our knowledge of atrial fibrillation and its treatment has increased considerably. There is a consensus that the posterior part of the left atrium and in particular the pulmonary veins are an important target for treatment. Surgical ablation with alternative energy sources is a new method under continued development and evaluation.

The optimal ablation treatment is unknown. A balance between invasiveness and achieving sinus rhythm in as many as possible has to be found. Creating numerous ablation lines in both atria is time consuming and leads probably to an increased need for permanent pacemaker implantation and reduced contractility of the atrial tissue. On the other hand can a simple bipolar ablation of pulmonary veins performed easily, but this is probably an insufficient treatment for most patients. In the protocol a new method using solely bipolar ablation for creation of several ablation lines in the left atrium is described.

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 AF over time.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 %

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184249

Locations
Norway
Haukeland Universitetssykehus HF
Bergen, Norway, 5021
Feiringklinikken
Feiring, Norway, 2093
Ullevål Universitetssykehuset HF
Oslo, Norway, 0407
Rikshospitalet-Radiumhospitalet HF
Oslo, Norway, 0027
Regionssykehuset i Tromsø HF
Tromsø, Norway, 9038
St. Elisabeth Department of Heart and Lung Surgery, St. Olavs Hospital
Trondheim, Norway, 7030
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Oslo University Hospital
Haukeland Sykehus HF
Ullevaal University Hospital
Regionssykehuset i Tromsø HF
Feiringklinikken
Investigators
Study Director: Alexander Wahba, Prof Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Prof Alexander Wahba, St. Elisabeth Dept of Heart and Lung Surgery
ClinicalTrials.gov Identifier: NCT00184249     History of Changes
Other Study ID Numbers: 120905
Study First Received: September 13, 2005
Last Updated: September 8, 2010
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
atrial fibrillation
bipolar ablation
heart surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 10, 2014