Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial)

Study Overview
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Brief Summary
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This clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. This group has a unique electrical conduction problem (Right Bundle Branch Block) that did not respond well to the current available pacing therapy.

Detailed Description
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This pilot clinical trial will be a randomized single blinded cross over trial. Each subject will undergo three study stages. Subject will be randomized initially to either of the two arms; experimental or placebo, and then will be followed up for 3 months for the first stage to assess outcomes. In the second stage, both arms transition to a two months, intervention free, wash out period. Finally, at the third stage both arms will cross over and subject will be followed up for an additional 3 months for outcomes assessment.

Official Title
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Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure, a Pilot Clinical Trial (The SPARK Trial)

Conditions
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Right Bundle-Branch Block, Heart Failure

Intervention / Treatment
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* Device: RV DDD(R)-60 with AV optimization
* Device: RV DDD(R)-60


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiomyopathy; ischemic or non-ischemic on optimal medical therapy per current heart failure treatment guidelines for at least 3 months. LVEF < 35% by trans-thoracic echocardiogram assessment Prior implantation of pacemaker/defibrillator with at least an atrial and RV mid septal lead. Atrial lead can be waived if RV lead has atrial sensing capabilities* Normal sinus rhythm at enrollment RBBB with QRS duration >120 msec on 12 lead surface EKG. PR interval <250 msec on 12 lead surface EKG Subjects with biventricular pacemaker/ICD will be eligible for enrollment if their LV lead pacing function has been turned off by the subject's primary cardiologist prior to study enrollment for at least 3 months (this could be due to lead malfunction or the decision to deactivate the LV pacing therapy for any reason per primary cardiologist discretion) Exclusion Criteria: Age younger than 18 years old Pregnancy Acute Myocardial infarction within 6 months of entry into the study Inotrope dependent heart failure condition Left ventricular assist device or heart transplantation Any other known conditions other than heart failure that could limit survival to < 6 months. Atrial fibrillation or flutter burden >10% of the time within the last 6 months Atrioventricular node disease that requires ventricular pacemaker support >10% of the time

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RV DDD(R)-60 with AV optimization<br>RBBB pacing | Device: RV DDD(R)-60 with AV optimization<br>* Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG<br>|
| Placebo Comparator: RV DDD(R)-60<br>Standard demand pacing | Device: RV DDD(R)-60<br>* AV settings programmed to minimize RV pacing - standard demand pacing programming.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive reverse left ventricular remodeling, defined as increase in LV Ejection Fraction >/=15% | Comparison of LV Ejection Fraction from baseline to intervention on. Comparison of LV Ejection Fraction from intervention off to intervention on. Statistically significant increase of >/= 15% | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiographic: QRS duration | Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on | Baseline, 3 months, 6 months | 
| Echocardiographic: LV end-diastolic diameters in cm | Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on | Baseline, 3 months, 6 months | 
| Heart failure symptoms (NYHA functional class). | Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on | Baseline, 3 months, 6 months | 
| Walking distance (6 minute walk test) in meters | Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant increase with intervention on | Baseline, 3 months, 6 months | 
| Quality of life (Minnesota living with heart failure questionnaire) | Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on | Baseline, 3 months, 6 months | 
| Laboratory: Plasma NT-proBNP | Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on | Baseline, 3 months, 6 months | 
| Ventricular arrhythmia burden. An episode is defined as ventricular tachycardia or fibrillation that requires anti-tachycardia pacing therapy, defibrillation or lasts >30 seconds | Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on | Baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Resynchronization therapy