Clinical trial NCT02441101: Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial)
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
Overall status: TERMINATED
Phase: NA
Conditions: Right Bundle-Branch Block
Heart Failure
Keywords: Cardiac Resynchronization therapy
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of LV Ejection Fraction Compared to Baseline
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Electrocardiographic: QRS Duration
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Michael C Giudici, MD
role: STUDY_CHAIR
affiliation: University of Iowa
name: Michael C Giudici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Shubba D Roy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Trisha Elliott, RTR
role: STUDY_DIRECTOR
References: