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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01559311
First received: March 19, 2012
Last updated: June 4, 2013
Last verified: June 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:
  • Left ventricular ejection fraction (LVEF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    LVEF for assessment of LV systolic function at 12 months post implant

  • Left ventricular end-systolic volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    LVESV for assessment of LV remodeling at 12 months post implant


Estimated Enrollment: 177
Study Start Date: February 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No Intervention: DDDR
Experimental: CRT Device: CRT
CRT Implant
Other Name: Implantation of LV lead

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Exclusion Criteria:

  • 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

Contacts
Contact: Louise Yim +852 2996 7605 lyim@sjm.com

Locations
China
Prince of Wales Hospital Recruiting
Hong Kong, China, 852
Contact: Cheuk Man Yu, MD    +852 2646 3200      
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

No publications provided

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
Last Updated: June 4, 2013
Health Authority: Hong Kong: Ethics Committee
India: Institutional Review Board
Italy: Ethics Committee
United Kingdom: Research Ethics Committee

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 September 16, 2014