CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Rate control +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00940056
NCT00940056N/ACompleted
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Totally Endoscopic Ablation of Atrial Fibrillation

Region Örebro County·interventional·Posted Jul 15, 2009·Updated Sep 5, 2016

In Brief

A clinical study evaluating Endoscopic ablation of AF and Rate control for Atrial Fibrillation. Completed, enrolled 36 participants across 1 site.

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesSweden
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 15, 2009
Enrollment StartNov 1, 2009
Primary CompletionMay 1, 2014
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.0 years ago

Interventions

Endoscopic ablation of AFprocedure

The procedure is conducted in general anaesthesia. The right chest is entered with three working ports . After a complete cycle of ablation creating a box lesion in the left atrium, conduction block is tested. A chest tube is placed through the most caudal port and the port incisions are closed. A Reveal loop recorder is then implanted subcutaneously. The patient is extubated and transferred to postoperative care.

Rate controldrug

Anti-arrhythmic protocol The control group is using a rate-control strategy. All patients keep their anti-arrhythmic/beta-blocker/digoxin medication during the entire follow-up. No attempts are made to rhythm-control the patients, unless subjective symptoms make it necessary.