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

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ClinicalTrials.gov Identifier: NCT02441101
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Michael C. Giudici, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Right Bundle-Branch Block Heart Failure Device: RV DDD(R)-60 with AV optimization Device: RV DDD(R)-60 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure, a Pilot Clinical Trial (The SPARK Trial)
Study Start Date : August 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  1. Positive reverse left ventricular remodeling, defined as increase in LV Ejection Fraction >15% [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Electrocardiographic: QRS duration [ Time Frame: 3 months ]
  2. Echocardiographic: LV end-systolic and diastolic diameters and volumes [ Time Frame: 3 months ]
  3. Echocardiographic: RV size and function [ Time Frame: 3 months ]
  4. Echocardiographic: severity of mitral and tricuspid valve regurgitation [ Time Frame: 3 months ]
  5. Echocardiographic: estimated pulmonary artery systolic pressure [ Time Frame: 3 months ]
  6. Echocardiographic: Inter-ventricular conduction delay [ Time Frame: 3 months ]
  7. Heart failure symptoms (NYHA functional class). [ Time Frame: 3 months ]
  8. Walking distance (6 minute walk test) [ Time Frame: 3 months ]
  9. Quality of life (Minnesota living with heart failure questionnaire) [ Time Frame: 3 months ]
  10. Laboratory: Plasma NT-proBNP [ Time Frame: 3 months ]
  11. Laboratory: Plasma Sodium [ Time Frame: 3 months ]
  12. Laboratory: Plasma BUN and Creatinine [ Time Frame: 3 months ]
  13. 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: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441101


Contacts
Contact: Michael C Giudici, MD 319-353-8153 michael-c-giudici@uiowa.edu
Contact: Ghanshym O Shantha, MBBS 319-353-8153 belal-alkhiami@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Michael C Giudici, MD         
Sub-Investigator: Belal O Al Khiami, MBBS         
Sponsors and Collaborators
Michael C. Giudici
Investigators
Study Chair: Michael C Giudici, MD University of Iowa
Principal Investigator: Michael C Giudici, MD University of Iowa
Study Director: Belal O Al Khiami, MD University of Iowa
Study Director: Prashant D Bhave, MD University of Iowa

Responsible Party: Michael C. Giudici, PI, University of Iowa
ClinicalTrials.gov Identifier: NCT02441101     History of Changes
Other Study ID Numbers: 201409760
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Michael C. Giudici, University of Iowa:
Cardiac Resynchronization therapy

Additional relevant MeSH terms:
Heart Failure
Bundle-Branch Block
Heart Block
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes