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

Overview

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.

Full Title of Study: “Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure, a Pilot Clinical Trial (The SPARK Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 11, 2020

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.

Interventions

  • Device: RV DDD(R)-60 with AV optimization
    • 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
  • Device: RV DDD(R)-60
    • AV settings programmed to minimize RV pacing – standard demand pacing programming.

Arms, Groups and Cohorts

  • Experimental: RV DDD(R)-60 with AV optimization
    • RBBB pacing
  • Placebo Comparator: RV DDD(R)-60
    • Standard demand pacing

Clinical Trial Outcome Measures

Primary Measures

  • Positive reverse left ventricular remodeling, defined as increase in LV Ejection Fraction >/=15%
    • Time Frame: Baseline, 3 months, 6 months
    • 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%

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Barry London
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Barry London, PI – University of Iowa
  • Overall Official(s)
    • Michael C Giudici, MD, Study Chair, University of Iowa
    • Michael C Giudici, MD, Principal Investigator, University of Iowa
    • Shubba D Roy, MD, Principal Investigator, University of Iowa
    • Trisha Elliott, RTR, Study Director, University of Iowa

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