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

Heart Failure Clinical Trial

— SPARK  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02441101
• Other study ID #: 201409760
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: February 11, 2020

Study information

• Verified date: September 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Block
• Heart Failure
• Right Bundle-Branch Block

Intervention

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
• RV DDD(R)-60
AV settings programmed to minimize RV pacing - standard demand pacing programming.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Barry London

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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