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 (ENHANCE)
Bradycardia
About this trial
This is an interventional prevention trial for Bradycardia focused on measuring Bradycardia
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
Sites / Locations
- The Prince Charles Hospital
- Prince of Wales Hospital
- Madras Medical Mission
- CARE Banjara
- All India Institute of Medical Sciences
- Istituto Clinico Humanitas
- Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Active Comparator
CRT-P OFF
CRT-P ON
DDDR
Patients randomized into the Echo-guided Group were implanted with a 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 absence of RVA pacing induced ventricular dyssynchrony were allocated to the DDDR standard therapy with CRT-P remained OFF
Patients randomized into the Echo-guided Group were implanted with a 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 randomized into the Control Group were implanted with a DDDR device (St. Jude Medical) standard therapy.