Atrial Fibrillation
Conditions
Keywords
Sinus node disease, AV node disease
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 the atrial fibrillation (AF) Suppression algorithm.
Interventions
DEVICEPacemaker implantation with RA lead in LAS position
Pacemaker implantation with RA lead placed in low atrial septal position
DEVICEPacemaker implantation with RA lead in RAA position
Pacemaker implantation with RA lead placed in right atrial appendage position
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 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
1. Already implanted with a pacemaker or implantable cardioverter defibrillator (ICD). 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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistent AF and chronic AF | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of cardioversions | 2 years |
| Safety and efficacy of low septal pacing | 2 years |
| Device diagnostic data: number of atrial high rate episode, mode switch episode and AF burden | 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 |
| Echocardiogram (Echo) parameters include left ventricular ejection fraction (LVEF) and diastolic index using Doppler Echo | 2 years |
Countries
Hong Kong
Outcome results
None listed