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

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:	February 2016
Estimated Primary Completion Date:	February 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

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:	March 19, 2012
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 May 21, 2013

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