Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Keywords: Bradycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-03-21
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

* Patient meets current indications for implantation of a DDDR pacemaker
* Patient is geographically stable and willing to comply with the required follow-up schedule
* Patient has LVEF \>45%
* Patient has atrioventricular block (IIo or above)
* Patient has adequate echocardiographic images to measure LV volumes and LVEF

Exclusion Criteria:

* Patient has permanent atrial fibrillation (AF)
* Patient has unstable angina or an acute coronary syndrome
* Patient has undergone percutaneous coronary intervention or coronary artery bypass surgery within the previous 3 months
* Patient's life expectancy is less than 1 year
* Patient is less than 18 years old
* Patient is pregnant
* Patient has received a heart transplant

Primary outcomes:
measure: LVEF
timeFrame: 12 months
measure: LVESV
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Chennai
country: India
facility: Madras Medical Mission
city: Hyderabad
country: India
facility: CARE Banjara
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
name: Cheuk Man Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: