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

NCT01559311 | Completed Results

• 1 other identifier: CR-10-003-AP-HF
• Study Type: interventional
• Target: 98
• Locations: 5 countries
• Sites: 7

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%).

Conditions

Bradycardia

Keywords

Bradycardia

Outcome Measures

Primary Outcomes (2)

• LVEF

  Left Ventricular Ejection Fraction (LVEF) for assessment of Left ventricular (LV) systolic function

  12 months

• LVESV

  Left ventricular end-systolic volume (LVESV) for assessment of LV remodeling

  12 months

Study Arms (3)

CRT-P OFF

ACTIVE COMPARATOR

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

Device: CRT-P OFF

CRT-P ON

EXPERIMENTAL

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

Device: CRT-P ON

DDDR

ACTIVE COMPARATOR

Patients randomized into the Control Group were implanted with a DDDR device (St. Jude Medical) standard therapy.

Device: DDDR

Interventions

CRT-P OFF DEVICE

CRT Pacemaker

CRT-P OFF

CRT-P ON DEVICE

CRT Pacemaker

CRT-P ON

DDDR DEVICE

Dual-chamber, rate-modulated pacemaker

DDDR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (7)

The Prince Charles Hospital

Chermside, Australia

Location

Prince of Wales Hospital

Hong Kong, China

Location

Madras Medical Mission

Chennai, India

Location

CARE Banjara

Hyderabad, India

Location

All India Institute of Medical Sciences

New Delhi, India

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

Siriraj Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Sample size was not reached due to difficulty in enrollment.

Results Point of Contact

• Title: Clinical Project Leader Asia
• Organization: St. Jude Medical (Hong Kong) Ltd

lyim@sjm.com

29967605

Study Officials

• Cheuk Man Yu, MD

  Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 21, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: April 1, 2016
• Last Updated: February 4, 2019
• Results First Posted: October 31, 2016

Record last verified: 2019-01

Locations

IT (1); AU (1); CN (1); TH (1); IN (3)