Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)

• Study Type: Observational
• Enrollment (Actual): 2044

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Frankston, Victoria, Australia, 3199
      • Peninsula Health
    • Geelong, Victoria, Australia, 3220
      • Barwon Health Myers House Ground Floor Geelong Hospital
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• Austria
  • Salzburg, Austria, 05020
    • Landeskrankenhaus Salzburg Universitätsklinikum der PMU
  • Vienna, Austria
    • Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik für Innere Medizin II
  • Vienna, Austria
    • Krankenhaus Nord
• Belgium
  • Hasselt, Belgium, 3500
    • Virga Jesse Ziekenhuis
  • Yvoir, Belgium, 5530
    • UCL de Mont Godinne
• Canada
  • Edmonton, Canada, T5H 3V9
    • Royal Alexandra Hospital - Cardiology Research CK Hui Heart Centre
  • Montréal, Canada, H4J 1C5
    • Hopital Du Sacre-Coeur de Montreal
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Fleurimont Hospital (CHU de Sherbrooke)
• Czechia
  • Brno, Czechia
    • Faculty Hospital U sv Anny
  • Pardubice, Czechia
    • Kardiologické Centrum AGEL
  • Praha, Czechia, 14021
    • IKEM - Institut klinicke a experimentalni mediciny
• France
  • Bayonne, France, 64100
    • Centre Hospitalier de la Côte Basque
  • Besançon, France, 25030
    • CHU de Besancon
  • Brest, France, 29200
    • CHU Brest - Hopital Cavale Blanche
  • Cannes, France
    • CH de Cannes
  • Créteil, France, 94010
    • APHP CHU Henri Mondor
  • Dijon, France, 21000
    • CHU Dijon
  • Marseille, France
    • Hôpital privé de Clairval
  • Massy, France, 91300
    • Hospital Prive Jacques Cartier
  • Metz-Tessy, France, 74370
    • Ch Annecy Genevois
  • Montpellier, France, 34000
    • Clinique du Millénaire
  • Nantes, France, 44277
    • NCN Nouvelles Cliniques Nantaises
  • Nîmes, France, 30029
    • CHU Nimes Cedex
  • Orléans, France, 45100
    • CHRU Orléans
  • Pau, France, 64000
    • CHG de Pau
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Salouël, France, 80480
    • CHU Amiens Hopital SUD
  • Toulouse, France, 31000
    • Clinique Pasteur
  • Tours, France
    • Clinique Saint Gatien
  • Tours, France, 37170
    • CHU TOURS - Hospital Trousseau
  • Trevenans, France
    • Hôpital Nord Franche-Comté
  • Trévenans, France, 90400
    • CH Belfort Montbeliard
  • Valence, France, 26000
    • Centre Hospitalier de Valence
• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Berlin, Germany, 12203
    • Charite Universitätsmedizin Berlin CBF
  • Bremen, Germany, 28277
    • Klinikum Links der Weser-Elektrophysiologie Bremen
  • Düsseldorf, Germany, 40472
    • Augusta Krankenhaus
  • Düsseldorf, Germany
    • Universitaetsklinikum Duesseldorf
  • Hamburg, Germany, 20251
    • Universitares Herzentrum Hamburg/Universitaetsklinik Eppendorf
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Hennigsdorf, Germany, 16761
    • Oberhavel Kliniken
  • Herne, Germany, 44627
    • Marien Hospital Herne
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig
  • Leverkusen, Germany, 51375
    • Klinikum Leverkusen gGmbH
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig-Holstein
  • Mainz, Germany, 55131
    • Universität Mainz zentrum fur kardiologie
  • Mannheim, Germany, 68167
    • Klinikum Mannheim GmbH
  • Monchengladbach, Germany
    • Kliniken Maria-Hilf GmbH
  • Munich, Germany, 80636
    • Deutsches Herzzentrum Muenchen
  • Nürnberg, Germany, 90491
    • Krankenhaus Martha Maria
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg AöR
  • Regensburg, Germany, 93053
    • Klinikum der Universitaet Regensburg
  • Würzburg, Germany, 97080
    • Universitaetsklinikum Wuerzburg
• Italy
  • Bari, Italy
    • Voc Cardiologia Ospedaliera Polocino di Bari
  • Catanzaro, Italy
    • Magna Graecia University AUO Mater Domini di Catanzaro
  • Ferrara, Italy
    • Azienda Ospedaliero - Universitaria di Ferrara
  • Lecce, Italy
    • Ospedale Vito Fazzi
  • Naples, Italy
    • Federico II University of Naples
  • Napoli, Italy, 80021
    • Ospedale Monaldi
  • Nuoro, Italy
    • Ospedale San Francesco
  • Padova, Italy
    • Azienda Ospedaliera Di Padova
  • Palmero, Italy
    • A.O.U. Policlinico Paolo Giaccone
  • Ragusa, Italy
    • Ospedale Maria Paternò Arezzo
  • Rome, Italy
    • Policlinico Casilino
  • Rome, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli
  • Rome, Italy
    • Ospedale San Pietro Fatebenefratelli
  • Rovigo, Italy
    • Ospedale Santa Maria della Misericordia di Rovigo
  • Varese, Italy, 21000
    • Azienda Socio-Sanitaria Territoriale dei Sette Laghi
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Noordwest Ziekenhuisgroep Alkmaar
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
  • Enschede, Netherlands, 7512 KZ
    • Medisch Spectrum Twente
  • Nijmegen, Netherlands, 6525 GA
    • UMC St. Radboud
  • Rotterdam, Netherlands, 3079 DZ
    • Maasstad Hospital
  • Rotterdam, Netherlands, 3015CE
    • Erasmus Medical Centre
• Portugal
  • Guimarães, Portugal
    • Hospital da Senhora da Oliveira
  • Lisboa, Portugal
    • Hospital Santa Maria (Centro Hospitalar de Lisboa Norte)
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto - Hospital de Santo António
• Slovakia
  • Bratislava, Slovakia, 83348
    • The National Institute of Cardiovascular Diseases
• Spain
  • Alicante, Spain
    • Hospital General Universitario
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebrón
  • Barcelona, Spain
    • Hospital Bellvitge
  • Ciudad Real, Spain, 13005
    • Hospital General de Ciudad Real
  • Granada, Spain
    • Hospital Virgen de las Nieves
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28031
    • Hospital Infanta Leonor
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Pamplona, Spain
    • Clinica Universidad de Navarra
  • Santa Cruz De Tenerife, Spain, 38320
    • Hospital Universitario de Canarias
  • Santander, Spain, 39011
    • Hospital Universitario Marques de Valdecilla
  • Sevilla, Spain
    • Hospital Virgen Macarena
  • Talavera de la Reina, Spain, 45600
    • Hospital Nuestra Señora del Prado
• Switzerland
  • Lausanne, Switzerland, CH-1011
    • CHUV Lausanne
• United Kingdom
  • Blackpool, United Kingdom
    • Blackpool Teaching Hospitals NHS Foundation Trust'
  • Bristol, United Kingdom
    • Bristol Heart Institute
  • Cambridge, United Kingdom
    • Addenbrookes Hospital
  • Cambridge, United Kingdom, CB23 3RE
    • Papworth Hospital
  • Glasgow, United Kingdom
    • Golden Jubilee National Hospital
  • Liverpool, United Kingdom
    • LHCH (Liverpool Heart and Chest Hospital)
  • London, United Kingdom, EC1A 7BE
    • St Bartholomews Hospital
  • Manchester, United Kingdom
    • Manchester Royal Infirmary
  • Northampton, United Kingdom, NN1 5BD
    • Northampton General Hospital
  • Plymouth, United Kingdom
    • Derriford Hospital
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • Basildon and Thurrock University Hospitals NHS Foundation Trust
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT9 7AB
      • Belfast City Hospital
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Providence Alaska Medical Center
  • Arizona
    • Mesa, Arizona, United States, 85206
      • CardioVascular Associates of Mesa
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Cardiovascular Medical Group
    • Loma Linda, California, United States, 92357
      • VA Loma Linda Healthcare System
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Western Connecticut Health Network/ Danbury Hospital
  • Florida
    • Brandon, Florida, United States, 33511
      • Bay Area Cardiology Associates, P.A.
    • Gainesville, Florida, United States, 32608
      • North Florida/South Georgia Veterans Health System
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Heart Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • The University of Illinois Medical Center
    • Kankakee, Illinois, United States, 60901
      • Riverside Medical Center / Midwest Arrhythmia Consultants
  • Indiana
    • Muncie, Indiana, United States, 47303
      • Ball Memorial Hospital
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Cardiovascular Institute of the South
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
    • Salisbury, Maryland, United States, 21804
      • Peninsula Cardiology Associates
  • Michigan
    • Flint, Michigan, United States, 48532
      • Hurley Medical Center
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Summit Medical Group, P.A.
  • New York
    • Buffalo, New York, United States, 14215
      • Trinity Medical WNY,PC
    • New York, New York, United States, 10032
      • Columbia. University Medical Center/ NY Presbyterian Hospital
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Regional Medical Center
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • St. Alexius Medical Center
  • Ohio
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Washington, Pennsylvania, United States, 15301
      • Regional Cardiac Arrythmia
  • Texas
    • Houston, Texas, United States, 77074
      • Texas Heart Rhythm
    • McAllen, Texas, United States, 78503
      • McAllen Medical Heart Hospital
    • San Antonio, Texas, United States, 78229
      • Cardiology Clinic of San Antonio
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NG4 PG Related Complication Free rate	Complication Free rate	36 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Jose-Ignacio Garcia-Bolao, PhD, FESC, Clinica Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2017
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: March 5, 2017
• First Submitted That Met QC Criteria: March 5, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: C1949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes