Status:
COMPLETED
SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation
Lead Sponsor:
Abbott Medical Devices
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized, parallel, single-blinded multi-center study. The objective is to compare the long term clinical outcomes among the site of atrial pacing and to compare the long term effect of th...
Eligibility Criteria
Inclusion
- Have a history of paroxysmal AF with documented AF episode within the last 6 months; documentation of AF is required. It can be documented by one of the following:
- Holter documentation and the strip must be at least 30 seconds; OR
- one page of 12-lead electrocardiogram (ECG); OR
- transtelephonic recording for more than 15 seconds.
- Have a conventional indication for a pacemaker due to either sinus or atrioventricular (AV) node diseases.
- Provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Be at least 18 years old.
Exclusion
- Already implanted with a pacemaker or implantable cardioverter defibrillator (ICD).
- Are expected to have heart surgery within the next 6 months.
- Have angina pectoris, New York Heart Association (NYHA) Class III or Class IV.
- Are expected not to be able to tolerate high rate pacing.
- Have less than 12 months' life expectancy.
- Are on the cardiac transplantation list.
- Are in chronic AF.
- Have a reversible aetiology of AF (e.g., hyperthyroidism, acute post-cardiac surgery AF, etc.).
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00419640
Start Date
May 1 2005
End Date
November 1 2012
Last Update
February 4 2019
Active Locations (1)
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1
Queen Mary Hospital, The University Hospital of Hong Kong
Hong Kong, Hong Kong