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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03075215




Registration number
NCT03075215
Ethics application status
Date submitted
5/03/2017
Date registered
9/03/2017
Date last updated
25/10/2023

Titles & IDs
Public title
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
Scientific title
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)
Secondary ID [1] 0 0
C1949
Universal Trial Number (UTN)
Trial acronym
SMART Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Treatment: Devices: Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)
The optimization during the standard of care visits in the first 12 months following implantation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CRT Response Rate
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications
Timepoint [2] 0 0
36 months

Eligibility
Key inclusion criteria
* Subject implanted or upgraded with a NG3 or NG4 CRT-D device connected with any manufacturer quadripolar LV lead based on BSC labeling for devices in specific geographies.
* Subjects must be enrolled between 1 and 21 calendar days post CRT-D implantation procedure.
* Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
* Subject is willing and capable of complying with follow-up visits and procedures as defined by this protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject with documented life expectancy of less than 12 months
* Subject currently on the active heart transplant list or has a current Left Ventricular Assist Device or other assist device (mechanical circulatory support device).
* Subject who have had a pre-existing CRT device
* Subject enrolled in any other concurrent clinical trial without prior written approval from BSC Clinical Trial Manager
* Women of childbearing potential who are or might be pregnant at time of study enrolment
* Any contra-indication to receive a CRT-D device per local guidelines

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/11/2021
Sample size
Target
Accrual to date
Final
2044
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Peninsula Health - Frankston
Recruitment hospital [4] 0 0
Barwon Health Myers House Ground Floor Geelong Hospital - Geelong
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alaska
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Arizona
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Arkansas
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Connecticut
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Indiana
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Texas
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Virginia
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Austria
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Salzburg
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Vienna
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Belgium
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Hasselt
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Edmonton
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Montréal
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Brno
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Alicante
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Barcelona
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Ciudad Real
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Granada
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Madrid
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Spain
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Pamplona
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Spain
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Santa Cruz De Tenerife
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Santander
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Sevilla
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Spain
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Talavera de la Reina
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Switzerland
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Lausanne
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Essex
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Northern Ireland
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Blackpool
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Bristol
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Cambridge
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Glasgow
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Liverpool
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London
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Manchester
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Northampton
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United Kingdom
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Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others.

A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.
Trial website
https://clinicaltrials.gov/study/NCT03075215
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jose-Ignacio Garcia-Bolao, PhD, FESC
Address 0 0
Clinica Universidad de Navarra
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03075215