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• Recruitment Status: Withdrawn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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation	Procedure: Bipolar radiofrequency ablation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Multi Centre Trial on Bipolar Radiofrequency Ablation of Atrial Fibrillation
• Study Start Date: June 2005
• Actual Primary Completion Date: June 2010
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bipolar radiofrequency ablation	Procedure: Bipolar radiofrequency ablation; Ablation using CE marked bipolar ablation devices; Other Names: Cardioblade; Atricure

Outcome Measures

Primary Outcome Measures :

1. Number of patients in sinus rhythm after 3, 6, and 12 months [ Time Frame: 3, 6, ]
2. Number of patients with atrial function at echo-doppler after 6 and 12 months [ Time Frame: 3,6, 12 months ]
3. Number of patients on anticoagulants after 6 and 12 months [ Time Frame: 6 and 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT00184249
• Other Study ID Numbers: 120905
• First Posted: September 16, 2005
• Last Update Posted: March 20, 2015
• Last Verified: March 2015

Keywords provided by Norwegian University of Science and Technology:

Catheter ablation; Heart/surgery; Cardial surgical procedures

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes