Atrial Fibrillation Clinical Trial
Official title:
Totally Endoscopic Ablation of Atrial Fibrillation
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?
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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