Heart FailureSMART RegistryNCT03075215
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
An observational study of Heart Failure, run by Boston Scientific Corporation at 139 sites in 15 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)
- Type of treatment
- Medical device
- How many people
- 2,044 participants
- Where
- 139 sitesin 15 countries
- Study dates
- 14 Apr 2017to 15 Nov 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects implanted with a quadripolar NG3 or NG4 CRT-D device in conjunction with a quadripolar lead from any manufacturer will be selected based on the inclusion/exclusion criteria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
139 sites in 15 countries.
139 sites in 15 countries
United States29 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Comprehensive Cardiovascular Medical Group
Bakersfield, California, 93309
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Summit Medical Group, P.A.
Berkeley Heights, New Jersey, 07922
St. Alexius Medical Center
Bismarck, North Dakota, 58501
Bay Area Cardiology Associates, P.A.
Brandon, Florida, 33511
Trinity Medical WNY,PC
Buffalo, New York, 14215
The University of Illinois Medical Center
Chicago, Illinois, 60612
Western Connecticut Health Network/ Danbury Hospital
Danbury, Connecticut, 06810
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Hurley Medical Center
Flint, Michigan, 48532
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
Northeast Georgia Heart Center
Gainesville, Georgia, 30501
Texas Heart Rhythm
Houston, Texas, 77074
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Riverside Medical Center / Midwest Arrhythmia Consultants
Kankakee, Illinois, 60901
Kettering Medical Center
Kettering, Ohio, 45429
Cardiovascular Institute of the South
Lafayette, Louisiana, 70503
VA Loma Linda Healthcare System
Loma Linda, California, 92357
McAllen Medical Heart Hospital
McAllen, Texas, 78503
CardioVascular Associates of Mesa
Mesa, Arizona, 85206
Ball Memorial Hospital
Muncie, Indiana, 47303
Columbia. University Medical Center/ NY Presbyterian Hospital
New York, New York, 10032
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Peninsula Cardiology Associates
Salisbury, Maryland, 21804
Cardiology Clinic of San Antonio
San Antonio, Texas, 78229
Regional Cardiac Arrythmia
Washington, Pennsylvania, 15301
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
France22 sites
Centre Hospitalier de la Cote Basque
Bayonne, 64100
CHU de Besancon
Besançon, 25030
CHU Brest - Hopital Cavale Blanche
Brest, 29200
Ch de Cannes
Cannes
APHP CHU Henri Mondor
Créteil, 94010
CHU Dijon
Dijon, 21000
Hopital Privé de Clairval
Marseille
Hospital Prive Jacques Cartier
Massy, 91300
CH Annecy Genevois
Metz-Tessy, 74370
Clinique du Millénaire
Montpellier, 34000
NCN Nouvelles Cliniques Nantaises
Nantes, 44277
CHU Nimes Cedex
Nîmes, 30029
Chru Orleans
Orléans, 45100
CHG de Pau
Pau, 64000
CHU de Poitiers
Poitiers, 86021
CHU Amiens hopital sud
Salouël, 80480
Clinique Pasteur
Toulouse, 31000
CHU TOURS - Hospital Trousseau
Tours, 37170
Clinique Saint Gatien
Tours
CH Belfort Montbeliard
Trévenans, 90400
Hôpital Nord Franche-Comté
Trévenans
Centre Hospitalier de Valence
Valence, 26000
Germany20 sites
Charite Universitätsmedizin Berlin CBF
Berlin, 12203
Deutsches Herzzentrum Berlin
Berlin, 13353
Klinikum Links der Weser-Elektrophysiologie Bremen
Bremen, 28277
Augusta Krankenhaus
Düsseldorf, 40472
Universitaetsklinikum Duesseldorf
Düsseldorf
Universitares Herzentrum Hamburg/Universitaetsklinik Eppendorf
Hamburg, 20251
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Oberhavel Kliniken
Hennigsdorf, 16761
Marien Hospital Herne
Herne, 44627
Universitätsklinikum Leipzig
Leipzig, 04103
Klinikum Leverkusen gGmbH
Leverkusen, 51375
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
Universität Mainz zentrum fur kardiologie
Mainz, 55131
Klinikum Mannheim GMBH
Mannheim, 68167
Kliniken Maria-Hilf GmbH
Mönchengladbach
Deutsches Herzzentrum Muenchen
Munich, 80636
Krankenhaus Martha Maria
Nuremberg, 90491
Klinikum Oldenburg AoR
Oldenburg, 26133
Klinikum der Universitaet Regensburg
Regensburg, 93053
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Italy15 sites
Voc Cardiologia Ospedaliera Polocino di Bari
Bari
Magna Graecia University AUO Mater Domini di Catanzaro
Catanzaro
Azienda Ospedaliero - Universitaria di Ferrara
Ferrara
Ospedale Vito Fazzi
Lecce
Ospedale Monaldi
Naples, 80021
Federico II University of Naples
Naples
Ospedale San Francesco
Nuoro
Azienda Ospedaliera di Padova
Padova
A.O.U. Policlinico Paolo Giaccone
Palmero
Ospedale Maria Paternò Arezzo
Ragusa
Fondazione Policlinico Universitario Agostino Gemelli
Rome
Ospedale San Pietro Fatebenefratelli
Rome
Policlinico Casilino
Rome
Ospedale Santa Maria della Misericordia di Rovigo
Rovigo
Azienda Socio-Sanitaria Territoriale dei Sette Laghi
Varese, 21000
Spain13 sites
Hospital General Universitario
Alicante
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Bellvitge
Barcelona
Hospital General de Ciudad Real
Ciudad Real, 13005
Hospital Virgen De Las Nieves
Granada
Hospital Infanta Leonor
Madrid, 28031
Hospital Clinico San Carlos
Madrid, 28040
Hospital La Paz
Madrid, 28046
Clinica Universidad de Navarra
Pamplona
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320
Hospital Universitario Marques De Valdecilla
Santander, 39011
Hospital Virgen Macarena
Seville
Hospital nuestra senora del prado
Talavera de la Reina, 45600
United Kingdom12 sites
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, Essex, SS16 5NL
Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB
Blackpool Teaching Hospitals NHS Foundation Trust'
Blackpool
Bristol Heart Institute
Bristol
Papworth Hospital
Cambridge, CB23 3RE
Addenbrookes Hospital
Cambridge
Golden Jubilee National Hospital
Glasgow
LHCH (Liverpool Heart and Chest Hospital)
Liverpool
St Bartholomews Hospital
London, EC1A 7BE
Manchester Royal Infirmary
Manchester
Northampton General Hospital
Northampton, NN1 5BD
Derriford Hospital
Plymouth
Netherlands6 sites
Noordwest Ziekenhuisgroep Alkmaar
Alkmaar, 1815 JD
Amphia Ziekenhuis
Breda, 4818 CK
Medisch Spectrum Twente
Enschede, 7512 KZ
UMC St. Radboud
Nijmegen, 6525 GA
Erasmus Medical Centre
Rotterdam, 3015CE
Maasstad Hospital
Rotterdam, 3079 DZ
Australia5 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Monash Medical Centre
Clayton, Victoria, 3168
Peninsula Health
Frankston, Victoria, 3199
Barwon Health Myers House Ground Floor Geelong Hospital
Geelong, Victoria, 3220
The Alfred Hospital
Melbourne, Victoria, 3004
Canada4 sites
Royal Alexandra Hospital - Cardiology Research CK Hui Heart Centre
Edmonton, T5H 3V9
Hôpital du Sacré-Cœur de Montréal
Montreal, H4J 1C5
Fleurimont Hospital (CHU de Sherbrooke)
Sherbrooke, Quebec, J1H 5N4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Austria3 sites
Landeskrankenhaus Salzburg Universitätsklinikum der PMU
Salzburg, 05020
Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik für Innere Medizin II
Vienna
Krankenhaus Nord
Vienna
Czechia3 sites
Faculty Hospital U sv Anny
Brno
Kardiologicke centrum AGEL
Pardubice
IKEM - Institut klinicke a experimentalni mediciny
Prague, 14021
Portugal3 sites
Hospital da Senhora da Oliveira
Guimarães
Hospital Santa Maria (Centro Hospitalar de Lisboa Norte)
Lisbon
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, 4099-001
Belgium2 sites
Virga Jesse Ziekenhuis
Hasselt, 3500
UCL de Mont Godinne
Yvoir, 5530
Slovakia1 site
The National Institute of Cardiovascular Diseases
Bratislava, 83348
About this study
Official title: Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)
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.
- Conditions
- Heart Failure
- Being tested
- Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)Device
The optimization during the standard of care visits in the first 12 months following implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
CRT Response Rate
The traditional outcome of interest when using the Clinical Composite Score (CCS) is the proportion of patients who improved. Improvement was defined as remaining alive and free of heart failure hospitalization while also demonstrating improvement in NYHA Class, patient Global Assessment, or both. Patients were considered worsened if they died, experienced a heart failure hospitalization, or had worsened NYHA Class or patient Global Assessment. Patients who neither improved nor worsened were classified as "no change."
Measured: 12 months
Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications
Complication Free rate. PG-related Complication is defined as those detectable adverse events that resulted in:
- Death
- Serious injury
- Correction of PG failure requiring invasive intervention
- Permanent loss of PG device function. Permanent loss of device function is defined as any Pulse Generator (PG) that reverts to Safety Core or any PG rendered unable to deliver pacing or shocks Complications that are determined to be associated with the PG will be considered PGrelated complications (PG) and count against the PMCF endpoint. Complications related to the LV, RV, RA leads will not be counted against the PMCF endpoint.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start14 Apr 2017
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,044 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose-Ignacio Garcia-Bolao, PhD, FESC, Principal investigator, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075215
- Sponsor's protocol ID
- C1949
- Acronym
- SMART Registry
- Status last verified
- Oct 2023
- First submitted
- 5 Mar 2017
- Last updated
- 25 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)
- ClinicalTrials.gov ID
- NCT03075215
- Acronym / sponsor ID
- SMART Registry / C1949
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,044 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 2 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects implanted with a quadripolar NG3 or NG4 CRT-D device in conjunction with a quadripolar lead from any manufacturer will be selected based on the inclusion/exclusion criteria
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | – |
Primary outcome
CRT Response Rate
Time frame: 12 months
The traditional outcome of interest when using the Clinical Composite Score (CCS) is the proportion of patients who improved. Improvement was defined as remaining alive and free of heart failure hospitalization while also demonstrating improvement in NYHA Class, patient Global Assessment, or both. Patients were considered worsened if they died, experienced a heart failure hospitalization, or had worsened NYHA Class or patient Global Assessment. Patients who neither improved nor worsened were classified as "no change."
Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications
Time frame: 36 months
Complication Free rate. PG-related Complication is defined as those detectable adverse events that resulted in: * Death * Serious injury * Correction of PG failure requiring invasive intervention * Permanent loss of PG device function. Permanent loss of device function is defined as any Pulse Generator (PG) that reverts to Safety Core or any PG rendered unable to deliver pacing or shocks Complications that are determined to be associated with the PG will be considered PGrelated complications (PG) and count against the PMCF endpoint. Complications related to the LV, RV, RA leads will not be counted against the PMCF endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose-Ignacio Garcia-Bolao, PhD, FESC principal investigator
Clinica Universidad de Navarra
139 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Boston Scientific Corporation at 139 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 139 sites in United States, France, Germany, Italy, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRT Response Rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.