Status:
COMPLETED
Totally Endoscopic Ablation of Atrial Fibrillation
Lead Sponsor:
Region Örebro County
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief 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 f...
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 ab...
Eligibility Criteria
Inclusion
- Age \> 50 years
- Longstanding persistent AF of \> 1 year duration
- Severe symptoms related to AF
- Have signed and dated Informed Consent.
- Willing and able to comply with the protocol for the duration of the trial.
Exclusion
- Severe ischemic heart disease or heart valve disease
- Thrombus formation in left atrial appendage
- Intolerance to warfarin medication
- Advanced pulmonary disease, FEV 1 \< 1.5 litre
- Left atrial diameter \> 60 mm
- Body Mass Index (BMI) \> 35 kg/m2
- Previous pulmonary or heart surgery
- Participation in another clinical trial within the last 30 days prior to enrollment
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00940056
Start Date
November 1 2009
End Date
May 1 2015
Last Update
September 5 2016
Active Locations (1)
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1
Örebro University Hospital
Örebro, Sweden, 70285