NCT01559311

ENHANCE-Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction

Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical project is to evaluate the efficacy of the presence of Right Ventricular Apical (RVA) pacing induced ventricular dyssynchrony as a guiding parameter for bi-ventricular pacing in patients with bradycardia and normal left ventricular ejection fraction (LVEF). The results of this project may provide with the evidence based medicine for guidelines expansion of using Cardiac resynchronization therapy (CRT) in patients with Heart Block and normal LVEF (LVEF \>45%).

Detailed description

All eligible patients willing to provide written informed consent were invited to participate in the study, and then randomized 1:2 to either the Control Group or Echo-guided Group. Patients randomized into the Control Group were implanted with a dual chamber pacemaker (DDDR) device (St. Jude Medical) standard therapy. Patients randomized into the Echo-guided Group were implanted with a cardiac resynchronization therapy pacemaker (CRT-P) device (St. Jude Medical), which was programmed to DDDR pacing mode (CRT-P OFF) at implant. For each Echo-guided Group patient, presence of RVA pacing induced ventricular dyssynchrony was assessed within 24-hour of implant using the standardized criteria of Doppler echocardiography. The Echocardiography Core Laboratory (Echo Core Lab) then analyzed each image and the treatment allocation of the Echo-guided Group was done within 72-hour post implant based on the Echo Core Lab outcomes: * Patients with the presence of RVA pacing induced ventricular dyssynchrony were allocated to the CRT-P standard therapy with CRT-P turned ON * Patients with the absence of RVA pacing induced ventricular dyssynchrony were allocated to the DDDR standard therapy with CRT-P remained OFF Patients meeting all the inclusion criteria and not meeting any of the exclusion criteria were eligible for the study. Data was collected at the following study visits:Enrollment, Implant \& Randomization, Pre-discharge (PDH) (≤ 72 hours post implant), Month 1 follow-up visit: 30 ± 14 days post implant, Month 3 follow-up visit: 90 ± 14 days post implant, Month 6 follow-up visit: 180 ± 14 days post implant and Month 12 follow-up visit: 365 ± 14 days post implant

Conditions

• Bradycardia

Interventions

Type	Name	Description
DEVICE	CRT-P OFF	CRT Pacemaker
DEVICE	CRT-P ON	CRT Pacemaker
DEVICE	DDDR	Dual-chamber, rate-modulated pacemaker

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-11-01
• Completion: 2016-04-01
• First posted: 2012-03-21
• Last updated: 2019-02-04
• Results posted: 2016-10-31

Locations

7 sites across 5 countries: Australia, China, India, Italy, Thailand