Left Ventricular Pacing to Avoid Cardiac Enlargement Study

Study Overview
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Brief Summary
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In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia with high risk for development of pacing-induced heart failure.

Detailed Description
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In this prospective, we will randomly assign 98 patients who need permanent pacemaker due to complete atrioventricular block or sick sinus syndrome to receive left ventricular pacing (49 patients) or right ventricular apical pacing (49 patients). Patients will be paced with temporary pacemaker lead, and only those with paced QRS duration ≥185 ms will be enrolled. The primary endpoint is left ventricular ejection fraction measured by modified Simpson method at 12 months. The secondary end points include left ventricular systolic end-systolic and diastolic volume, LV strain, NYHA functional class, exercise performance (using treadmill test), quality of life (using SF-36v2), NT-proBNP at 12 months.

Official Title
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Impact of Left Ventricular Pacing on Left Ventricular Systolic Function in High-risk Bradycardia Patients

Conditions
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Complete AV Block, Sick Sinus Syndrome

Intervention / Treatment
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* Device: LV pacing
* Device: RV pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sinus-node dysfunction or bradycardia due to advanced atrioventricular block Paced QRS duration ≥185 ms Exclusion Criteria: Left ventricular ejection fraction < 50 % Acute coronary syndrome If they had undergone percutaneous coronary intervention or coronary-artery bypass surgery within the previous 3 months if they had a life expectancy of less than 1 year if they had received a heart transplant

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Right ventricular pacing<br> | Device: RV pacing<br>* The right ventricular lead are positioned at the right ventricular apex.<br>|
| Experimental: Left ventricular pacing<br> | Device: LV pacing<br>* The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (%) at 12 months | Measured by modified Simpson's method | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular end-systolic volume (ml) at 12 months | Measured by modified Simpson method | 12 months | 
| Left ventricular end-diastolic volume (ml) at 12 months | Measured by modified Simpson method | 12 months | 
| NYHA functional class |  | 12 months | 
| Functional capacity | measured by treadmill test | 12 months | 
| NT-proBNP | plasma level | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left ventricular pacing