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

NCT02441101 | Terminated Results DMC

• 1 other identifier: 201409760
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Bundle-Branch Block; Heart Failure

Keywords

Cardiac Resynchronization therapy

Outcome Measures

Primary Outcomes (1)

• Change of LV Ejection Fraction Compared to Baseline

  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

  Baseline to 3 months

Secondary Outcomes (1)

• Electrocardiographic: QRS Duration

  Baseline to 3 months

Study Arms (2)

RV pacing optimization on/off

EXPERIMENTAL

RBBB pacing Arm 1 is RV pacing optimization on/off

Device: RV DDD(R)-60 with AV optimization

RV pacing optimization off/on

PLACEBO COMPARATOR

Standard demand pacing Arm 2 is RV pacing optimization off/on

Device: RV DDD(R)-60

Interventions

RV DDD(R)-60 with AV optimization DEVICE

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

RV pacing optimization on/off

RV DDD(R)-60 DEVICE

AV settings programmed to minimize RV pacing - standard demand pacing programming.

RV pacing optimization off/on

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Barry London: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Bundle-Branch Block; Heart Failure

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Barry London
• Organization: University of Iowa

barry-london@uiowa.edu

319-356-2750

Study Officials

• Michael C Giudici, MD

  University of Iowa

  STUDY CHAIR

• Michael C Giudici, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Shubba D Roy, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Trisha Elliott, RTR

  University of Iowa

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 12, 2015
• Study Start: February 1, 2016
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Locations

US (1)