Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure, a Pilot Clinical Trial (The SPARK Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Change of LV Ejection Fraction Compared to Baseline
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
RV pacing optimization on/off
RBBB pacing Arm 1 is RV pacing optimization on/off
Intervention: RV DDD(R)-60 with AV optimization (Device)
RV pacing optimization off/on
Standard demand pacing Arm 2 is RV pacing optimization off/on
Intervention: RV DDD(R)-60 (Device)
Outcomes
Primary Outcomes
Change of LV Ejection Fraction Compared to Baseline
Time Frame: Baseline to 3 months
LV Ejection Fraction is defined as \[(end diastolic volume minus end systolic volume) / (end diastolic volume\] as measured by echocardiography. Comparison of LV Ejection Fraction with RV pacing optimization on vs. RV pacing optimization off. Arm 1 is RV pacing optimization on then off Arm 2 is RV pacing optimization off then on
Secondary Outcomes
- Electrocardiographic: QRS Duration(Baseline to 3 months)
Investigators
Barry London
PI
University of Iowa