NCT02441101

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Barry London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Right Bundle-Branch Block
• Heart Failure

Interventions

Type	Name	Description
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
DEVICE	RV DDD(R)-60	AV settings programmed to minimize RV pacing - standard demand pacing programming.

Timeline

• Start date: 2016-02-01
• Primary completion: 2020-02-11
• Completion: 2020-02-11
• First posted: 2015-05-12
• Last updated: 2024-06-18
• Results posted: 2024-06-18

Locations

1 site across 1 country: United States