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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00184249
Recruitment Status : Withdrawn (Collaborators did not enter patients into the study)
First Posted : September 16, 2005
Last Update Posted : March 20, 2015
Sponsor:
Collaborators:
St. Olavs Hospital
Oslo University Hospital
Haukeland Sykehus HF
Ullevaal University Hospital
Regionssykehuset i Tromsø HF
Feiringklinikken
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date March 20, 2015
Study Start Date  ICMJE June 2005
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
  • Number of patients in sinus rhythm after 3, 6, and 12 months [ Time Frame: 3, 6, ]
  • Number of patients with atrial function at echo-doppler after 6 and 12 months [ Time Frame: 3,6, 12 months ]
  • Number of patients on anticoagulants after 6 and 12 months [ Time Frame: 6 and 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Number of patients in sinus rhythm after 3, 6, and 12 months
  • Number of patients with atrial function at echo-doppler after 6 and 12 months
  • Number of patients on anticoagulants after 6 and 12 months
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Multi Centre Trial on Bipolar Radiofrequency Ablation of Atrial Fibrillation
Official Title  ICMJE A Prospective Multi Centre Trial on Bipolar Radiofrequency Ablation of Atrial Fibrillation
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Procedure: Bipolar radiofrequency ablation
Ablation using CE marked bipolar ablation devices
Other Names:
  • Cardioblade
  • Atricure
Study Arms  ICMJE Experimental: Bipolar radiofrequency ablation
Intervention: Procedure: Bipolar radiofrequency ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 18, 2015)
0
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
50
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Norway
 
Administrative Information
NCT Number  ICMJE NCT00184249
Other Study ID Numbers  ICMJE 120905
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • St. Olavs Hospital
  • Oslo University Hospital
  • Haukeland Sykehus HF
  • Ullevaal University Hospital
  • Regionssykehuset i Tromsø HF
  • Feiringklinikken
Investigators  ICMJE
Study Director: Alexander Wahba, Prof Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP