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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

This study is currently recruiting participants.
Verified March 2012 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01559311
First received: March 19, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 19, 2012
March 19, 2012
February 2012
February 2016   (final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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%).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Bradycardia
Device: CRT
CRT Implant
Other Name: Implantation of LV lead
  • No Intervention: Control
  • No Intervention: DDDR
  • Experimental: CRT
    Intervention: Device: CRT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
177
February 2016
February 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Louise Yim +852 2996 7605 lyim@sjm.com
China
 
NCT01559311
CR-10-003-AP-HF
Yes
St. Jude Medical
St. Jude Medical
Not Provided
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
St. Jude Medical
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP