Totally Endoscopic Ablation of Atrial Fibrillation (TEA)

September 2, 2016 updated by: Anders Ahlsson, Region Örebro County

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 70285
        • Örebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rate control
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.
Experimental: Endoscopic ablation of atrial fibrillation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs
Time Frame: 3-12 months
3-12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Collaborators

Medtronic

Investigators

  • Principal Investigator: Anders Ahlsson, MD PhD, Department of Cardiothoracic Surgery
  • Study Chair: Espen Fengsrud, MD, Department of Cardiology
  • Study Director: Anders Englund, MD PhD, Stockholm Arrhythmia Center
  • Study Chair: Peter Linde, MD, Department of Cardiology
  • Study Chair: Henrik Almroth, MD, Department of Cardiology
  • Study Chair: Tommy Andersson, MD, Department of Cardiology
  • Study Chair: Hans Tyden, MD PhD, Department of Cardiothoracic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHOrebro

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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