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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 the atrial fibrillation (AF) Suppression algorithm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS + DAO ON | Experimental | The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON. |
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| LAS + DAO OFF | Experimental | The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF. |
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| RAA + DAO ON | Experimental | The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON. |
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| RAA + DAO OFF | Active Comparator | The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker implantation with RA lead in LAS position | Device | Pacemaker implantation with RA lead placed in low atrial septal position |
|
| Measure | Description | Time Frame |
|---|---|---|
| Persistent AF and chronic AF | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Device diagnostic data: number of atrial high rate episode, mode switch episode and AF burden | 2 years | |
| Number of cardioversions | 2 years | |
| Safety and efficacy of low septal pacing |
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Inclusion Criteria:
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:
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 Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chu-Pak Lau, Prof. | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital, The University Hospital of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23868858 | Derived | 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. |
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| Pacemaker implantation with RA lead in LAS position | Device | Pacemaker implantation with RA lead placed in low atrial septal position |
|
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| Pacemaker implantation with RA lead in RAA position | Device | Pacemaker implantation with RA lead placed in right atrial appendage position |
|
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| Pacemaker implantation with RA lead in RAA position | Device | Pacemaker implantation with RA lead placed in right atrial appendage position |
|
|
| 2 years |
| Echocardiogram (Echo) parameters include left ventricular ejection fraction (LVEF) and diastolic index using Doppler Echo | 2 years |
| Quality-of-life questionnaire: Short Form-36 (SF-36) | 2 years |
| Major cardiovascular events: heart failure, stroke, hospitalization, and cardiovascular mortality | 2 years |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001146 | Arrhythmia, Sinus |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
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