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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)

Primary Purpose

Bradycardia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CRT-P OFF
CRT-P ON
DDDR
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bradycardia focused on measuring Bradycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

CRT-P OFF

CRT-P ON

DDDR

Arm Description

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.

Outcomes

Primary Outcome Measures

LVEF
Left Ventricular Ejection Fraction (LVEF) for assessment of Left ventricular (LV) systolic function
LVESV
Left ventricular end-systolic volume (LVESV) for assessment of LV remodeling

Secondary Outcome Measures

Full Information

First Posted
March 19, 2012
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01559311
Brief Title
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
Acronym
ENHANCE
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
Keywords
Bradycardia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT-P OFF
Arm Type
Active Comparator
Arm Description
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
Arm Title
CRT-P ON
Arm Type
Experimental
Arm Description
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
Arm Title
DDDR
Arm Type
Active Comparator
Arm Description
Patients randomized into the Control Group were implanted with a DDDR device (St. Jude Medical) standard therapy.
Intervention Type
Device
Intervention Name(s)
CRT-P OFF
Intervention Description
CRT Pacemaker
Intervention Type
Device
Intervention Name(s)
CRT-P ON
Intervention Description
CRT Pacemaker
Intervention Type
Device
Intervention Name(s)
DDDR
Intervention Description
Dual-chamber, rate-modulated pacemaker
Primary Outcome Measure Information:
Title
LVEF
Description
Left Ventricular Ejection Fraction (LVEF) for assessment of Left ventricular (LV) systolic function
Time Frame
12 months
Title
LVESV
Description
Left ventricular end-systolic volume (LVESV) for assessment of LV remodeling
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheuk Man Yu, MD
Organizational Affiliation
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince Charles Hospital
City
Chermside
Country
Australia
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China
Facility Name
Madras Medical Mission
City
Chennai
Country
India
Facility Name
CARE Banjara
City
Hyderabad
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
Country
India
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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