SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation
NCT ID: NCT00419640
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
385 participants
INTERVENTIONAL
2005-05-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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LAS + DAO ON
The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON.
Pacemaker implantation with RA lead in LAS position
Pacemaker implantation with RA lead placed in low atrial septal position
LAS + DAO OFF
The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF.
Pacemaker implantation with RA lead in LAS position
Pacemaker implantation with RA lead placed in low atrial septal position
RAA + DAO ON
The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON.
Pacemaker implantation with RA lead in RAA position
Pacemaker implantation with RA lead placed in right atrial appendage position
RAA + DAO OFF
The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF.
Pacemaker implantation with RA lead in RAA position
Pacemaker implantation with RA lead placed in right atrial appendage position
Interventions
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Pacemaker implantation with RA lead in LAS position
Pacemaker implantation with RA lead placed in low atrial septal position
Pacemaker implantation with RA lead in LAS position
Pacemaker implantation with RA lead placed in low atrial septal position
Pacemaker implantation with RA lead in RAA position
Pacemaker implantation with RA lead placed in right atrial appendage position
Pacemaker implantation with RA lead in RAA position
Pacemaker implantation with RA lead placed in right atrial appendage position
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
2. Have a conventional indication for a pacemaker due to either sinus or atrioventricular (AV) node diseases.
3. Provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
4. Be at least 18 years old.
Exclusion Criteria
2. Are expected to have heart surgery within the next 6 months.
3. Have angina pectoris, New York Heart Association (NYHA) Class III or Class IV.
4. Are expected not to be able to tolerate high rate pacing.
5. Have less than 12 months' life expectancy.
6. Are on the cardiac transplantation list.
7. Are in chronic AF.
8. Have a reversible aetiology of AF (e.g., hyperthyroidism, acute post-cardiac surgery AF, etc.).
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Chu-Pak Lau, Prof.
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Queen Mary Hospital, The University Hospital of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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Lau CP, Tachapong N, Wang CC, Wang JF, Abe H, Kong CW, Liew R, Shin DG, Padeletti L, Kim YH, Omar R, Jirarojanakorn K, Kim YN, Chen MC, Sriratanasathavorn C, Munawar M, Kam R, Chen JY, Cho YK, Li YG, Wu SL, Bailleul C, Tse HF; Septal Pacing for Atrial Fibrillation Suppression Evaluation Study Group. Prospective randomized study to assess the efficacy of site and rate of atrial pacing on long-term progression of atrial fibrillation in sick sinus syndrome: Septal Pacing for Atrial Fibrillation Suppression Evaluation (SAFE) Study. Circulation. 2013 Aug 13;128(7):687-93. doi: 10.1161/CIRCULATIONAHA.113.001644. Epub 2013 Jul 18.
Other Identifiers
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CR04032AF
Identifier Type: -
Identifier Source: org_study_id
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