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

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Right Bundle-Branch Block
• Intervention / Treatment: Device: RV DDD(R)-60 with AV optimization; Device: RV DDD(R)-60

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael C Giudici, MD; Phone Number: 319-353-8153; Email: michael-c-giudici@uiowa.edu
• Study Contact Backup: Name: Shubha D Roy, MD; Phone Number: 319-384-8001; Email: shubhadeep-roy@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RV DDD(R)-60 with AV optimization; RBBB pacing	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
Placebo Comparator: RV DDD(R)-60; Standard demand pacing	Device: RV DDD(R)-60; AV settings programmed to minimize RV pacing - standard demand pacing programming.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Barry London
• Investigators: Study Chair: Michael C Giudici, MD, University of Iowa; Principal Investigator: Michael C Giudici, MD, University of Iowa; Principal Investigator: Shubba D Roy, MD, University of Iowa; Study Director: Trisha Elliott, RTR, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): February 11, 2020
• Study Completion (Actual): February 11, 2020

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimated): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac Resynchronization therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Failure; Bundle-Branch Block; Heart Block
• Other Study ID Numbers: 201409760