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

• ClinicalTrials.gov Identifier: NCT00184249
• Recruitment Status: Withdrawn
• First Posted: September 16, 2005
• Last Update Posted: March 20, 2015
• Sponsor: Norwegian University of Science and Technology
• 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: September 13, 2005
• First Posted Date: September 16, 2005
• Last Update Posted Date: March 20, 2015
• Study Start Date: June 2005
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Prospective Multi Centre Trial on Bipolar Radiofrequency Ablation of Atrial Fibrillation
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Atrial Fibrillation

Intervention

Procedure: Bipolar radiofrequency ablation

Ablation using CE marked bipolar ablation devices

Other Names:

• Cardioblade
• Atricure

Study Arms

Experimental: Bipolar radiofrequency ablation

Intervention: Procedure: Bipolar radiofrequency ablation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: March 18, 2015): 0
• Original Enrollment (submitted: September 13, 2005): 50
• Actual Study Completion Date: June 2012
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Norway

Administrative Information

• NCT Number: NCT00184249
• Other Study ID Numbers: 120905
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Norwegian University of Science and Technology
• Original Responsible Party: Not Provided
• Current Study Sponsor: Norwegian University of Science and Technology
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: Norwegian University of Science and Technology
• Verification Date: March 2015