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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01559311




Registration number
NCT01559311
Ethics application status
Date submitted
19/03/2012
Date registered
21/03/2012
Date last updated
4/02/2019

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
CR-10-003-AP-HF
Universal Trial Number (UTN)
Trial acronym
ENHANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CRT-P OFF
Treatment: Devices - CRT-P ON
Treatment: Devices - DDDR

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

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

Active Comparator: DDDR - Patients randomized into the Control Group were implanted with a DDDR device (St. Jude Medical) standard therapy.


Treatment: Devices: CRT-P OFF
CRT Pacemaker

Treatment: Devices: CRT-P ON
CRT Pacemaker

Treatment: Devices: DDDR
Dual-chamber, rate-modulated pacemaker

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
LVEF - Left Ventricular Ejection Fraction (LVEF) for assessment of Left ventricular (LV) systolic function
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
LVESV - Left ventricular end-systolic volume (LVESV) for assessment of LV remodeling
Timepoint [2] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hong Kong
Country [2] 0 0
India
State/province [2] 0 0
Chennai
Country [3] 0 0
India
State/province [3] 0 0
Hyderabad
Country [4] 0 0
India
State/province [4] 0 0
New Delhi
Country [5] 0 0
Italy
State/province [5] 0 0
Rozzano
Country [6] 0 0
Thailand
State/province [6] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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%).
Trial website
https://clinicaltrials.gov/show/NCT01559311
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cheuk Man Yu, MD
Address 0 0
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications