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Totally Endoscopic Ablation of Atrial Fibrillation

NCT00940056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-09-05

No results posted yet for this study

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?

Conditions

Interventions

PROCEDURE

Endoscopic ablation of AF

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.

DRUG

Rate control

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Anders Ahlsson, MD PhD · Department of Cardiothoracic Surgery

  • Espen Fengsrud, MD · Department of Cardiology

  • Anders Englund, MD PhD · Stockholm Arrhythmia Center

  • Peter Linde, MD · Department of Cardiology

  • Henrik Almroth, MD · Department of Cardiology

  • Tommy Andersson, MD · Department of Cardiology

  • Hans Tyden, MD PhD · Department of Cardiothoracic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-05-31
Completion
2015-05-31

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00940056 on ClinicalTrials.gov