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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03075215
Ethics application status
Date submitted
5/03/2017
Date registered
9/03/2017
Date last updated
2/04/2020

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 - Clinical Composite Score
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
NG4 PG Related Complication Free rate - Complication Free rate
Timepoint [1] 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
Gender
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
Active, not recruiting
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)
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
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United States of America
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Arizona
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Arkansas
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Louisiana
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Maryland
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Michigan
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Pennsylvania
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Texas
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Virginia
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Austria
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Salzburg
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Austria
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Vienna
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Belgium
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Hasselt
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Belgium
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Yvoir
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Edmonton
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Canada
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Montréal
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Czechia
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Brno
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Czechia
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Pardubice
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Czechia
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Praha
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France
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Bayonne
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France
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Besançon
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France
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Brest
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Cannes
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France
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Créteil
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Dijon
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Marseille
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France
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Massy
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Metz-Tessy
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France
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Montpellier
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France
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Nantes
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France
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Nîmes
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France
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Orléans
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France
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Pau
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France
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Poitiers
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France
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Salouël
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Toulouse
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Tours
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France
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Trévenans
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France
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Valence
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Germany
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Berlin
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Germany
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Bremen
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Germany
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Düsseldorf
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Hennigsdorf
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Germany
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Herne
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Germany
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Leipzig
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Germany
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Leverkusen
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Germany
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Lübeck
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Monchengladbach
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Germany
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Munich
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Germany
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Nürnberg
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Oldenburg
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Germany
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Regensburg
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Germany
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Würzburg
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Italy
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Bari
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Italy
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Catanzaro
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Italy
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Ferrara
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Italy
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Lecce
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Naples
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Napoli
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Italy
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Nuoro
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Alkmaar
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Netherlands
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Breda
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Enschede
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Nijmegen
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Rotterdam
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Portugal
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Guimarães
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Portugal
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Lisboa
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Portugal
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Porto
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Slovakia
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Bratislava
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Ciudad Real
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Spain
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Granada
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Spain
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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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Spain
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Santander
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Spain
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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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United Kingdom
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Essex
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United Kingdom
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Northern Ireland
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Blackpool
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United Kingdom
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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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United Kingdom
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Manchester
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United Kingdom
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Northampton
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United Kingdom
State/province [115] 0 0
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/show/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
Other publications