NCT01169493

Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis. Approximately half of all HF patients have electrocardiographic prolongation of the QRS interval and ventricular dyssynchrony, a perturbation of the normal pattern of ventricular contraction that reduces the efficiency of ventricular work. Ventricular dyssynchrony is directly responsible for worsening HF symptomatology in this subset of patients. Resynchronization of ventricular contraction is usually achieved through simultaneous pacing of the left and right ventricles using a biventricular (BiV) pacemaker or implantable cardioverter-defibrillator. Clinical trial evidence supporting the use of BiV pacing in patients with prolonged QRS duration was obtained almost exclusively in patients with a left bundle-branch block (LBBB) electrocardiographic pattern. Recent evidence suggests that resynchronization of ventricular contraction in patients with LBBB can be obtained by univentricular left ventricular pacing with equal or superior clinical benefits compared to BiV pacing. Animal studies suggest that ventricular resynchronization can be obtained in subjects with right bundle-branch block (RBBB) through univentricular right ventricular pacing. No clinical trial evidence exists to support the use of BiV pacing in patients with RBBB. Thousands of patients with symptomatic HF and RBBB currently have univentricular ICDs in place for the prevention of sudden cardiac death. Most of these devices are currently programmed to avoid RV pacing. We aim to determine if ventricular resynchronization delivered through univentricular RV pacing improves symptoms in patients with RBBB and moderate to severe HF who have previously undergone BiV ICD implantation for symptomatic heart failure. We further aim to determine if ventricular resynchronization improves myocardial performance and ventricular geometry as detected by echocardiographic measures and quality of life for patients with HF and RBBB. We hypothesize that RV univentricular pacing delivered with an atrio-ventricular interval that maximizes ventricular synchrony is equivalent to BiV pacing for improvement in cardiac performance, HF symptoms, and positive ventricular remodeling in patients with HF and RBBB.

Conditions

• Heart Failure
• Right Bundle-Branch Block

Interventions

Type	Name	Description
DEVICE	VVI-40	Pacing mode set to VVI-40, RV only pacing
DEVICE	RV DDD-40	ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
DEVICE	BiV DDD-40	ICD programmed to BiV pacing at a lower rate of 40

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2010-07-26
• Last updated: 2016-09-23
• Results posted: 2015-09-30

Locations

2 sites across 1 country: United States