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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
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The goal of this clinical trial is to compare two pacemaker strategies: Left Bundle Branch Area Pacing (LBBAP) and Minimized Ventricular Pacing (MVP) in patients requiring a permanent pacemaker for sick sinus syndrome and prolonged AV interval. It will also evaluate the safety and feasibility of the LBBAP method in these patients.
The main questions it aims to answer is:
*Is LBBAP with physiological AV interval better than Minimized Ventricular Pacing?
Researchers will compare the LBBAP group (aiming for conduction system capture with physiological AV intervals) to the MVP group (aiming to minimize ventricular pacing with prolonged AV intervals) to evaluate the optimal pacing strategy.
Participants will:
Eligible subjects who provide written informed consent will be randomly assigned in a 1:1 ratio to either the LBBAP group or the MVP group. Randomization will be available 24 hours a day using an Interactive Web Response System (IWRS). Randomization will be stratified by the presence of a history of AF. For patients who meet the inclusion and exclusion criteria before the procedure, randomization will be performed beforehand. For patients with SSS requiring PPM implantation, whose AV conduction status cannot be evaluated before the procedure due to conditions such as junctional rhythm, marked bradycardia (<50 bpm), or isorhythmic dissociation, randomization can be performed after the demonstration of PR with atrial pacing at a targeted atrial rate of 60 bpm during the procedure.
LBBAP group
LBB pacing -Lead position deep in the interventricular septum, ~1-2cm from the distal His bundle potential, LBB potential to QRS interval in the range of 15-34 ms, normal QRS axis, fulfilled criteria for conduction system capture.
Left fascicular pacing
-Capture of the LBB fascicles or its distal arborization, short potential to QRS interval (<25ms), abnormal paced QRS axis with presence of criteria for conduction system capture. Pacing is more distant from the His bundle (2-4cm), defined as left anterior, mid-septal, and posterior fascicle.
Left ventricular septal pacing)
The primary objective for the LBBAP group is the achievement of conduction system capture with LBBAP. However, based on the physician's discretion or the situations in the operating room, His bundle pacing can be accepted as alternatives to LBBAP.
MVP group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBBAP | Experimental |
| |
| MVP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBBAP | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of composite of all-cause mortality, heart failure hospitalization and persistent atrial fibrillation |
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| - All cause mortality | All cases of mortality after randomization will be counted. | 2 years |
| - Ischemic stroke or systemic embolism | Composite of ischemic stroke or systemic embolism during follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural complications | Complications related to the procedure | Periprocedural |
| Incidence of subclinical AF with pre-specified durations | AF lasting >5min, >1 hour, >6 hours, >1 day, and >7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Songpa-gu | 05505 | South Korea |
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| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| MVP | Device |
|
|
| 2 years |
| Heart failure rehospitalization |
| 2 years |
| Any rehospitalization | Any rehospitalization after randomization | 2 years |
| Rehospitalization from cardiac cause | Rehospitalization for the deterioration of cardiovascular conditions | 2 years |
| Quality of life measurement | Quality of life questionnaire and baseline and 24 months. Quality of life is assessed using: 1) 36-Item Short Form Health Survey (SF-36), and 2) Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). Both scales range from 0 to 100, with higher scores indicating better health status. | 2 years |
| Incidence of Clinical AF | AF detected on 12-lead or other forms of ECG | 2 years |
| Quality of life measurement | Quality of life questionnaire and baseline and 24 months. Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). This instrument comprises 36 questions covering 8 health domains. Each domain is scored on a scale from 0 to 100, with higher scores indicating a better quality of life/health status | 2 years |
| 2 years |
| Procedural success | Achievement of LBB area pacing (%) | Periprocedural |
| D006327 |
| Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |