Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
SMART Registry
1 other identifier
observational
2,044
14 countries
134
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Longer than P75 for all trials
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedStudy Start
First participant enrolled
April 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2021
CompletedResults Posted
Study results publicly available
October 2, 2023
CompletedOctober 25, 2023
October 1, 2023
4.6 years
March 5, 2017
November 1, 2022
October 11, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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."
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.
36 months
Interventions
The optimization during the standard of care visits in the first 12 months following implantation
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (139)
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
CardioVascular Associates of Mesa
Mesa, Arizona, 85206, United States
Arrhythmia Research Group
Jonesboro, Arkansas, 72401, United States
Comprehensive Cardiovascular Medical Group
Bakersfield, California, 93309, United States
VA Loma Linda Healthcare System
Loma Linda, California, 92357, United States
Western Connecticut Health Network/ Danbury Hospital
Danbury, Connecticut, 06810, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, 33511, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608, United States
Northeast Georgia Heart Center
Gainesville, Georgia, 30501, United States
The University of Illinois Medical Center
Chicago, Illinois, 60612, United States
Riverside Medical Center / Midwest Arrhythmia Consultants
Kankakee, Illinois, 60901, United States
Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803, United States
Cardiovascular Institute of the South
Lafayette, Louisiana, 70503, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Peninsula Cardiology Associates
Salisbury, Maryland, 21804, United States
Hurley Medical Center
Flint, Michigan, 48532, United States
Summit Medical Group, P.A.
Berkeley Heights, New Jersey, 07922, United States
Trinity Medical WNY,PC
Buffalo, New York, 14215, United States
Columbia. University Medical Center/ NY Presbyterian Hospital
New York, New York, 10032, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Regional Cardiac Arrythmia
Washington, Pennsylvania, 15301, United States
Texas Heart Rhythm
Houston, Texas, 77074, United States
McAllen Medical Heart Hospital
McAllen, Texas, 78503, United States
Cardiology Clinic of San Antonio
San Antonio, Texas, 78229, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Peninsula Health
Frankston, Victoria, 3199, Australia
Barwon Health Myers House Ground Floor Geelong Hospital
Geelong, Victoria, 3220, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Landeskrankenhaus Salzburg Universitätsklinikum der PMU
Salzburg, 05020, Austria
Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik fĂ¼r Innere Medizin II
Vienna, Austria
Krankenhaus Nord
Vienna, Austria
Virga Jesse Ziekenhuis
Hasselt, 3500, Belgium
UCL de Mont Godinne
Yvoir, 5530, Belgium
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Fleurimont Hospital (CHU de Sherbrooke)
Sherbrooke, Quebec, J1H 5N4, Canada
Royal Alexandra Hospital - Cardiology Research CK Hui Heart Centre
Edmonton, T5H 3V9, Canada
HĂ´pital du SacrĂ©-CÅ“ur de MontrĂ©al
Montreal, H4J 1C5, Canada
Faculty Hospital U sv Anny
Brno, Czechia
Kardiologicke centrum AGEL
Pardubice, Czechia
IKEM - Institut klinicke a experimentalni mediciny
Prague, 14021, Czechia
Centre Hospitalier de la Cote Basque
Bayonne, 64100, France
CHU de Besancon
Besançon, 25030, France
CHU Brest - Hopital Cavale Blanche
Brest, 29200, France
Ch de Cannes
Cannes, France
APHP CHU Henri Mondor
Créteil, 94010, France
CHU Dijon
Dijon, 21000, France
Hopital Privé de Clairval
Marseille, France
Hospital Prive Jacques Cartier
Massy, 91300, France
CH Annecy Genevois
Metz-Tessy, 74370, France
Clinique du Millénaire
Montpellier, 34000, France
NCN Nouvelles Cliniques Nantaises
Nantes, 44277, France
CHU Nimes Cedex
Nîmes, 30029, France
Chru Orleans
Orléans, 45100, France
CHG de Pau
Pau, 64000, France
CHU de Poitiers
Poitiers, 86021, France
CHU Amiens hopital sud
Salouël, 80480, France
Clinique Pasteur
Toulouse, 31000, France
CHU TOURS - Hospital Trousseau
Tours, 37170, France
Clinique Saint Gatien
Tours, France
CH Belfort Montbeliard
Trévenans, 90400, France
Hôpital Nord Franche-Comté
Trévenans, France
Centre Hospitalier de Valence
Valence, 26000, France
Charite Universitätsmedizin Berlin CBF
Berlin, 12203, Germany
Deutsches Herzzentrum Berlin
Berlin, 13353, Germany
Klinikum Links der Weser-Elektrophysiologie Bremen
Bremen, 28277, Germany
Augusta Krankenhaus
DĂ¼sseldorf, 40472, Germany
Universitaetsklinikum Duesseldorf
DĂ¼sseldorf, Germany
Universitares Herzentrum Hamburg/Universitaetsklinik Eppendorf
Hamburg, 20251, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Oberhavel Kliniken
Hennigsdorf, 16761, Germany
Marien Hospital Herne
Herne, 44627, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum Leverkusen gGmbH
Leverkusen, 51375, Germany
Universitätsklinikum Schleswig-Holstein
LĂ¼beck, 23538, Germany
Universität Mainz zentrum fur kardiologie
Mainz, 55131, Germany
Klinikum Mannheim GMBH
Mannheim, 68167, Germany
Kliniken Maria-Hilf GmbH
Mönchengladbach, Germany
Deutsches Herzzentrum Muenchen
Munich, 80636, Germany
Krankenhaus Martha Maria
Nuremberg, 90491, Germany
Klinikum Oldenburg AoR
Oldenburg, 26133, Germany
Klinikum der Universitaet Regensburg
Regensburg, 93053, Germany
Universitaetsklinikum Wuerzburg
WĂ¼rzburg, 97080, Germany
Voc Cardiologia Ospedaliera Polocino di Bari
Bari, Italy
Magna Graecia University AUO Mater Domini di Catanzaro
Catanzaro, Italy
Azienda Ospedaliero - Universitaria di Ferrara
Ferrara, Italy
Ospedale Vito Fazzi
Lecce, Italy
Federico II University of Naples
Naples, Italy
Ospedale Monaldi
Napoli, 80021, Italy
Ospedale San Francesco
Nuoro, Italy
Azienda Ospedaliera di Padova
Padua, Italy
A.O.U. Policlinico Paolo Giaccone
Palmero, Italy
Ospedale Maria PaternĂ² Arezzo
Ragusa, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy
Ospedale San Pietro Fatebenefratelli
Rome, Italy
Policlinico Casilino
Rome, Italy
Ospedale Santa Maria della Misericordia di Rovigo
Rovigo, Italy
Azienda Socio-Sanitaria Territoriale dei Sette Laghi
Varese, 21000, Italy
Noordwest Ziekenhuisgroep Alkmaar
Alkmaar, 1815 JD, Netherlands
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Medisch Spectrum Twente
Enschede, 7512 KZ, Netherlands
UMC St. Radboud
Nijmegen, 6525 GA, Netherlands
Erasmus Medical Centre
Rotterdam, 3015CE, Netherlands
Maasstad Hospital
Rotterdam, 3079 DZ, Netherlands
Hospital da Senhora da Oliveira
GuimarĂ£es, Portugal
Hospital Santa Maria (Centro Hospitalar de Lisboa Norte)
Lisbon, Portugal
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, 4099-001, Portugal
The National Institute of Cardiovascular Diseases
Bratislava, 83348, Slovakia
Hospital General Universitario
Alicante, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Bellvitge
Barcelona, Spain
Hospital General de Ciudad Real
Ciudad Real, 13005, Spain
Hospital Virgen De Las Nieves
Granada, Spain
Hospital Infanta Leonor
Madrid, 28031, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital La Paz
Madrid, 28046, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320, Spain
Hospital Universitario Marques De Valdecilla
Santander, 39011, Spain
Hospital Virgen Macarena
Seville, Spain
Hospital nuestra senora del prado
Talavera de la Reina, 45600, Spain
CHUV Lausanne
Lausanne, CH-1011, Switzerland
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, Essex, SS16 5NL, United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust'
Blackpool, United Kingdom
Bristol Heart Institute
Bristol, United Kingdom
Papworth Hospital
Cambridge, CB23 3RE, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
LHCH (Liverpool Heart and Chest Hospital)
Liverpool, United Kingdom
St Bartholomews Hospital
London, EC1A 7BE, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Northampton General Hospital
Northampton, NN1 5BD, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations include a lack of a control group, but a non-randomized observational study with 2005 subjects is appropriate to meet the study's objectives to obtain "real world" therapy outcome. Due to COVID-19, there was an increase in missed visits/withdrawals, the impact to the data was minimal, 75.8% of 12-month visits were before March 2020 and there was sufficient data to power the 36-month analysis.
Results Point of Contact
- Title
- Clinical Trial Manager
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Jose-Ignacio Garcia-Bolao, PhD, FESC
Clinica Universidad de Navarra
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2017
First Posted
March 9, 2017
Study Start
April 14, 2017
Primary Completion
November 15, 2021
Study Completion
November 15, 2021
Last Updated
October 25, 2023
Results First Posted
October 2, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share