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

Primary Purpose

Right Bundle-Branch Block, Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RV DDD(R)-60 with AV optimization
RV DDD(R)-60
Sponsored by
Barry London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Right Bundle-Branch Block focused on measuring Cardiac Resynchronization therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RV DDD(R)-60 with AV optimization

RV DDD(R)-60

Arm Description

RBBB pacing

Standard demand pacing

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Electrocardiographic: QRS duration
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
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Heart failure symptoms (NYHA functional class).
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
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)
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Laboratory: Plasma NT-proBNP
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
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on

Full Information

First Posted
May 6, 2015
Last Updated
September 21, 2023
Sponsor
Barry London
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1. Study Identification

Unique Protocol Identification Number
NCT02441101
Brief Title
Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial)
Acronym
SPARK
Official Title
Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure, a Pilot Clinical Trial (The SPARK Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
PI left the institution
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
February 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Barry London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Bundle-Branch Block, Heart Failure
Keywords
Cardiac Resynchronization therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RV DDD(R)-60 with AV optimization
Arm Type
Experimental
Arm Description
RBBB pacing
Arm Title
RV DDD(R)-60
Arm Type
Placebo Comparator
Arm Description
Standard demand pacing
Intervention Type
Device
Intervention Name(s)
RV DDD(R)-60 with AV optimization
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
RV DDD(R)-60
Intervention Description
AV settings programmed to minimize RV pacing - standard demand pacing programming.
Primary Outcome Measure Information:
Title
Positive reverse left ventricular remodeling, defined as increase in LV Ejection Fraction >/=15%
Description
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%
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Electrocardiographic: QRS duration
Description
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Time Frame
Baseline, 3 months, 6 months
Title
Echocardiographic: LV end-diastolic diameters in cm
Description
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Time Frame
Baseline, 3 months, 6 months
Title
Heart failure symptoms (NYHA functional class).
Description
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Time Frame
Baseline, 3 months, 6 months
Title
Walking distance (6 minute walk test) in meters
Description
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant increase with intervention on
Time Frame
Baseline, 3 months, 6 months
Title
Quality of life (Minnesota living with heart failure questionnaire)
Description
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Time Frame
Baseline, 3 months, 6 months
Title
Laboratory: Plasma NT-proBNP
Description
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Time Frame
Baseline, 3 months, 6 months
Title
Ventricular arrhythmia burden. An episode is defined as ventricular tachycardia or fibrillation that requires anti-tachycardia pacing therapy, defibrillation or lasts >30 seconds
Description
Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael C Giudici, MD
Organizational Affiliation
University of Iowa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael C Giudici, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shubba D Roy, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trisha Elliott, RTR
Organizational Affiliation
University of Iowa
Official's Role
Study Director
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

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

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