NCT02441101: SPARK

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

Terminated NA Results posted Last updated 18 June 2024

What this trial tests

NA trial testing RV DDD(R)-60 with AV optimization in Right Bundle-Branch Block in 6 participants. Terminated before completion.

Timeline

1 February 2016

Primary endpoint
11 February 2020

11 February 2020

Quick facts

Lead sponsor	Barry London
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	6
Start date	1 February 2016
Primary completion	11 February 2020
Estimated completion	11 February 2020
Sites	1 location across United States

Drugs / interventions tested

• RV DDD(R)-60 with AV optimization
• RV DDD(R)-60

Conditions studied

• Right Bundle-Branch Block — all drugs for Right Bundle-Branch Block →
• Heart Failure — all drugs for Heart Failure →

Sponsor

Barry London

Who can join

18 and older, any sex, with Right Bundle-Branch Block or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change of LV Ejection Fraction Compared to Baseline Primary · Baseline to 3 months

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

Group	Value	95% CI
RV Pacing Optimization on	0	± 4
RV Pacing Optimization Off	4	± 7

Electrocardiographic: QRS Duration Secondary · Baseline to 3 months

Comparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on

Group	Value	95% CI
RV Pacing Optimization on	-36	± 22
RV Pacing Optimization Off	2	± 9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.