Clinical trial NCT03075215: Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
Official title: Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-03-09
Enrollment: 2044
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: CRT Response Rate
timeFrame: 12 months
measure: Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Mesa
country: United States
facility: CardioVascular Associates of Mesa
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Cardiovascular Medical Group
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Danbury
country: United States
facility: Western Connecticut Health Network/ Danbury Hospital
state: Connecticut
city: Brandon
country: United States
facility: Bay Area Cardiology Associates, P.A.
state: Florida
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center
state: Georgia
city: Chicago
country: United States
facility: The University of Illinois Medical Center
state: Illinois
city: Kankakee
country: United States
facility: Riverside Medical Center / Midwest Arrhythmia Consultants
state: Illinois
city: Muncie
country: United States
facility: Ball Memorial Hospital
state: Indiana
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Lafayette
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Cardiology Associates
state: Maryland
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Berkeley Heights
country: United States
facility: Summit Medical Group, P.A.
state: New Jersey
city: Buffalo
country: United States
facility: Trinity Medical WNY,PC
state: New York
city: New York
country: United States
facility: Columbia. University Medical Center/ NY Presbyterian Hospital
state: New York
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Bismarck
country: United States
facility: St. Alexius Medical Center
state: North Dakota
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Washington
country: United States
facility: Regional Cardiac Arrythmia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Heart Rhythm
state: Texas
city: McAllen
country: United States
facility: McAllen Medical Heart Hospital
state: Texas
city: San Antonio
country: United States
facility: Cardiology Clinic of San Antonio
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Health
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health Myers House Ground Floor Geelong Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg Universitätsklinikum der PMU
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik für Innere Medizin II
city: Vienna
country: Austria
facility: Krankenhaus Nord
city: Hasselt
country: Belgium
facility: Virga Jesse Ziekenhuis
city: Yvoir
country: Belgium
facility: UCL de Mont Godinne
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Sherbrooke
country: Canada
facility: Fleurimont Hospital (CHU de Sherbrooke)
state: Quebec
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital - Cardiology Research CK Hui Heart Centre
city: Montréal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
city: Brno
country: Czechia
facility: Faculty Hospital U sv Anny
city: Pardubice
country: Czechia
facility: Kardiologicke centrum AGEL
city: Praha
country: Czechia
facility: IKEM - Institut klinicke a experimentalni mediciny
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque
city: Besançon
country: France
facility: CHU de Besancon
city: Brest
country: France
facility: CHU Brest - Hopital Cavale Blanche
city: Cannes
country: France
facility: Ch de Cannes
city: Créteil
country: France
facility: APHP CHU Henri Mondor
city: Dijon
country: France
facility: CHU Dijon
city: Marseille
country: France
facility: Hopital Privé de Clairval
city: Massy
country: France
facility: Hospital Prive Jacques Cartier
city: Metz-Tessy
country: France
facility: CH Annecy Genevois
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Nantes
country: France
facility: NCN Nouvelles Cliniques Nantaises
city: Nîmes
country: France
facility: CHU Nimes Cedex
city: Orléans
country: France
facility: Chru Orleans
city: Pau
country: France
facility: CHG de Pau
city: Poitiers
country: France
facility: CHU de Poitiers
city: Salouël
country: France
facility: CHU Amiens hopital sud
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHU TOURS - Hospital Trousseau
city: Tours
country: France
facility: Clinique Saint Gatien
city: Trevenans
country: France
facility: Hôpital Nord Franche-Comté
city: Trévenans
country: France
facility: CH Belfort Montbeliard
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin CBF
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bremen
country: Germany
facility: Klinikum Links der Weser-Elektrophysiologie Bremen
city: Düsseldorf
country: Germany
facility: Augusta Krankenhaus
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Hamburg
country: Germany
facility: Universitares Herzentrum Hamburg/Universitaetsklinik Eppendorf
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Hennigsdorf
country: Germany
facility: Oberhavel Kliniken
city: Herne
country: Germany
facility: Marien Hospital Herne
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen gGmbH
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Mainz
country: Germany
facility: Universität Mainz zentrum fur kardiologie
city: Mannheim
country: Germany
facility: Klinikum Mannheim GMBH
city: Monchengladbach
country: Germany
facility: Kliniken Maria-Hilf GmbH
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Nürnberg
country: Germany
facility: Krankenhaus Martha Maria
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AoR
city: Regensburg
country: Germany
facility: Klinikum der Universitaet Regensburg
city: Würzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Bari
country: Italy
facility: Voc Cardiologia Ospedaliera Polocino di Bari
city: Catanzaro
country: Italy
facility: Magna Graecia University AUO Mater Domini di Catanzaro
city: Ferrara
country: Italy
facility: Azienda Ospedaliero - Universitaria di Ferrara
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Naples
country: Italy
facility: Federico II University of Naples
city: Napoli
country: Italy
facility: Ospedale Monaldi
city: Nuoro
country: Italy
facility: Ospedale San Francesco
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palmero
country: Italy
facility: A.O.U. Policlinico Paolo Giaccone
city: Ragusa
country: Italy
facility: Ospedale Maria Paternò Arezzo
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Rome
country: Italy
facility: Ospedale San Pietro Fatebenefratelli
city: Rome
country: Italy
facility: Policlinico Casilino
city: Rovigo
country: Italy
facility: Ospedale Santa Maria della Misericordia di Rovigo
city: Varese
country: Italy
facility: Azienda Socio-Sanitaria Territoriale dei Sette Laghi
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep Alkmaar
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira
city: Lisboa
country: Portugal
facility: Hospital Santa Maria (Centro Hospitalar de Lisboa Norte)
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo Antonio
city: Bratislava
country: Slovakia
facility: The National Institute of Cardiovascular Diseases
city: Alicante
country: Spain
facility: Hospital General Universitario
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Granada
country: Spain
facility: Hospital Virgen De Las Nieves
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital La Paz
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Santander
country: Spain
facility: Hospital Universitario Marques De Valdecilla
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Talavera de la Reina
country: Spain
facility: Hospital nuestra senora del prado
city: Lausanne
country: Switzerland
facility: CHUV Lausanne
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock University Hospitals NHS Foundation Trust
state: Essex
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
state: Northern Ireland
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust'
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Liverpool
country: United Kingdom
facility: LHCH (Liverpool Heart and Chest Hospital)
city: London
country: United Kingdom
facility: St Bartholomews Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: Clinica Universidad de Navarra
name: Jose-Ignacio Garcia-Bolao, PhD, FESC
role: PRINCIPAL_INVESTIGATOR
References: