Totally Endoscopic Ablation of Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rate control; Procedure: Endoscopic ablation of AF

• Registration Number: NCT00940056
• Lead Sponsor: Region Örebro County

Brief Summary

Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to rate control management of AF.

Secondary Objectives

Does totally endoscopic ablation:

* reduce atrial fibrillation symptoms?

* increase working capacity and improve quality of life?

* improve atrial function?

* reduce the risk for stroke?

Detailed Description

This is a randomized open controlled single centre study that involves 60 patients (men and women) over the age of 50 years with longstanding persistent AF of more than one year duration and in the absence of other severe cardiopulmonary disease. One of the participating investigators informs the patient, both verbally and in writing, about the study and what participation in the study involves. The patient will be given time to ask questions and to consider study participation and can be enrolled in the study after signing and dating written Informed Consent. Study duration per patient is 12 months.

After inclusion, the patient will be divided into one of two groups, treatment group or control group, according to block wise randomization. The patient will be asked to complete two health related questionnaires SF 36 and SCL and a transthoracic echocardiography will be conducted together with an exercise test.

The patients will thereafter be assessed according to randomisation. Irrespective of group, the patients will be rescheduled for a visit within two months for totally endoscopic ablation and Reveal implantation or just Reveal implantation (control group). All patients will then be assessed during follow-ups after 1, 3, 6 and 12 months.

Study Timeline

• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Study Start: 2009-11
• Primary Completion: 2014-05
• Study Completion: 2015-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Age > 50 years
2. Longstanding persistent AF of > 1 year duration
3. Severe symptoms related to AF
4. Have signed and dated Informed Consent.
5. Willing and able to comply with the protocol for the duration of the trial.

Exclusion Criteria

1. Severe ischemic heart disease or heart valve disease
2. Thrombus formation in left atrial appendage
3. Intolerance to warfarin medication
4. Advanced pulmonary disease, FEV 1 < 1.5 litre
5. Left atrial diameter > 60 mm
6. Body Mass Index (BMI) > 35 kg/m2
7. Previous pulmonary or heart surgery
8. Participation in another clinical trial within the last 30 days prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rate control	Rate control	-
Endoscopic ablation of atrial fibrillation	Endoscopic ablation of AF	-

Primary Outcome Measures

Name	Time	Method
Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs	3-12 months

Secondary Outcome Measures

Name	Time	Method
Freedom of symptomatic AF episodes 3 - 12 months	3-12 months
Exercise capacity after 12 months	12 months
Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months	12 months
Atrial function and dimensions after 6 and 12 months	12 months
Freedom of thromboembolic events during the study	12 months

Trial Locations

Locations (1)

Örebro University Hospital; 🇸🇪 Örebro, Sweden