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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01559311
First received: March 19, 2012
Last updated: September 7, 2016
Last verified: September 2016
  Purpose
The purpose of this clinical project is to evaluate the efficacy of the presence of 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 CRT in patients with Heart Block and normal LVEF (LVEF >45%).

Condition Intervention
Bradycardia
Device: CRT-P OFF
Device: CRT-P ON
Device: DDDR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • LVEF [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    LVEF for assessment of LV systolic function

  • LVESV [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    LV end-systolic volume (LVESV) for assessment of LV remodeling


Enrollment: 98
Study Start Date: February 2012
Study Completion Date: April 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CRT-P 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 absence of RVA pacing induced ventricular dyssynchrony were allocated to the DDDR standard therapy with CRT-P remained OFF

Device: CRT-P OFF
CRT Pacemaker
Experimental: CRT-P ON

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
CRT Pacemaker
Active Comparator: DDDR
Patients randomized into the Control Group were implanted with a DDDR device (St. Jude Medical) standard therapy.
Device: DDDR
Dual-chamber, rate-modulated pacemaker

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 DDDR device (St. Jude Medical) standard therapy. 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 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 LV ejection fraction

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559311

Locations
China
Prince of Wales Hospital
Hong Kong, China, 852
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Cheuk Man Yu, MD Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01559311     History of Changes
Other Study ID Numbers: CR-10-003-AP-HF 
Study First Received: March 19, 2012
Results First Received: September 7, 2016
Last Updated: September 7, 2016
Health Authority: Hong Kong: Ethics Committee
India: Institutional Review Board
Italy: Ethics Committee
Thailand: Ethical Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by St. Jude Medical:
Bradycardia

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on December 09, 2016