Totally Endoscopic Ablation of Atrial Fibrillation (TEA)

Region Örebro County

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Rate control; Procedure: Endoscopic ablation of AF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00940056

UHOrebro

Details and patient eligibility

About

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?

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Endoscopic ablation of atrial fibrillation

Experimental group

Treatment:

Procedure: Endoscopic ablation of AF

Rate control

Active Comparator group

Treatment:

Drug: Rate control