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

Barry London

Status: Terminated

Conditions: Right Bundle-Branch Block; Heart Failure

Treatments: Device: RV DDD(R)-60; Device: RV DDD(R)-60 with AV optimization

Study type: Interventional

Funder types: Other

Identifiers

NCT02441101

201409760

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

6 participants in 2 patient groups, including a placebo group

RV pacing optimization on/off

Experimental group

Description:

RBBB pacing Arm 1 is RV pacing optimization on/off

Treatment:

Device: RV DDD(R)-60 with AV optimization

RV pacing optimization off/on

Placebo Comparator group

Description:

Standard demand pacing Arm 2 is RV pacing optimization off/on

Treatment:

Device: RV DDD(R)-60