Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry

Heart Failure Clinical Trial

— SMART Registry  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075215
• Other study ID #: C1949
• Status: Completed
• Start date: April 14, 2017
• Est. completion date: November 15, 2021

Study information

• Verified date: October 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2044
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• 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

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Peninsula Health	Frankston	Victoria
Australia	Barwon Health Myers House Ground Floor Geelong Hospital	Geelong	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Austria	Landeskrankenhaus Salzburg Universitätsklinikum der PMU	Salzburg
Austria	Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik für Innere Medizin II	Vienna
Austria	Krankenhaus Nord	Vienna
Belgium	Virga Jesse Ziekenhuis	Hasselt
Belgium	UCL de Mont Godinne	Yvoir
Canada	Royal Alexandra Hospital - Cardiology Research CK Hui Heart Centre	Edmonton
Canada	Hôpital du Sacré-Cœur de Montréal	Montréal
Canada	Fleurimont Hospital (CHU de Sherbrooke)	Sherbrooke	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Czechia	Faculty Hospital U sv Anny	Brno
Czechia	Kardiologicke centrum AGEL	Pardubice
Czechia	IKEM - Institut klinicke a experimentalni mediciny	Praha
France	Centre Hospitalier de la Cote Basque	Bayonne
France	CHU de Besancon	Besançon
France	CHU Brest - Hopital Cavale Blanche	Brest
France	Ch de Cannes	Cannes
France	APHP CHU Henri Mondor	Créteil
France	CHU Dijon	Dijon
France	Hopital Privé de Clairval	Marseille
France	Hospital Prive Jacques Cartier	Massy
France	CH Annecy Genevois	Metz-Tessy
France	Clinique du Millénaire	Montpellier
France	NCN Nouvelles Cliniques Nantaises	Nantes
France	CHU Nimes Cedex	Nîmes
France	Chru Orleans	Orléans
France	CHG de Pau	Pau
France	CHU de Poitiers	Poitiers
France	CHU Amiens hopital sud	Salouël
France	Clinique Pasteur	Toulouse
France	CHU TOURS - Hospital Trousseau	Tours
France	Clinique Saint Gatien	Tours
France	Hôpital Nord Franche-Comté	Trevenans
France	CH Belfort Montbeliard	Trévenans
France	Centre Hospitalier de Valence	Valence
Germany	Charite Universitätsmedizin Berlin CBF	Berlin
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Klinikum Links der Weser-Elektrophysiologie Bremen	Bremen
Germany	Augusta Krankenhaus	Düsseldorf
Germany	Universitaetsklinikum Duesseldorf	Düsseldorf
Germany	Universitares Herzentrum Hamburg/Universitaetsklinik Eppendorf	Hamburg
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Oberhavel Kliniken	Hennigsdorf
Germany	Marien Hospital Herne	Herne
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Klinikum Leverkusen gGmbH	Leverkusen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Universität Mainz zentrum fur kardiologie	Mainz
Germany	Klinikum Mannheim GMBH	Mannheim
Germany	Kliniken Maria-Hilf GmbH	Monchengladbach
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Krankenhaus Martha Maria	Nürnberg
Germany	Klinikum Oldenburg AoR	Oldenburg
Germany	Klinikum der Universitaet Regensburg	Regensburg
Germany	Universitaetsklinikum Wuerzburg	Würzburg
Italy	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
Italy	Ospedale San Francesco	Nuoro
Italy	Azienda Ospedaliera di Padova	Padova
Italy	A.O.U. Policlinico Paolo Giaccone	Palmero
Italy	Ospedale Maria Paternò 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
Netherlands	Noordwest Ziekenhuisgroep Alkmaar	Alkmaar
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	UMC St. Radboud	Nijmegen
Netherlands	Erasmus Medical Centre	Rotterdam
Netherlands	Maasstad Hospital	Rotterdam
Portugal	Hospital da Senhora da Oliveira	Guimarães
Portugal	Hospital Santa Maria (Centro Hospitalar de Lisboa Norte)	Lisboa
Portugal	Centro Hospitalar do Porto - Hospital de Santo Antonio	Porto
Slovakia	The National Institute of Cardiovascular Diseases	Bratislava
Spain	Hospital General Universitario	Alicante
Spain	Hospital Bellvitge	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital General de Ciudad Real	Ciudad Real
Spain	Hospital Virgen De Las Nieves	Granada
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital La Paz	Madrid
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Universitario de Canarias	Santa Cruz De Tenerife
Spain	Hospital Universitario Marques De Valdecilla	Santander
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital nuestra senora del prado	Talavera de la Reina
Switzerland	CHUV Lausanne	Lausanne
United Kingdom	Basildon and Thurrock University Hospitals NHS Foundation Trust	Basildon	Essex
United Kingdom	Belfast City Hospital	Belfast	Northern Ireland
United Kingdom	Blackpool Teaching Hospitals NHS Foundation Trust'	Blackpool
United Kingdom	Bristol Heart Institute	Bristol
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	LHCH (Liverpool Heart and Chest Hospital)	Liverpool
United Kingdom	St Bartholomews Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	Northampton General Hospital	Northampton
United Kingdom	Derriford Hospital	Plymouth
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	Comprehensive Cardiovascular Medical Group	Bakersfield	California
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Summit Medical Group, P.A.	Berkeley Heights	New Jersey
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	Bay Area Cardiology Associates, P.A.	Brandon	Florida
United States	Trinity Medical WNY,PC	Buffalo	New York
United States	The University of Illinois Medical Center	Chicago	Illinois
United States	Western Connecticut Health Network/ Danbury Hospital	Danbury	Connecticut
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Hurley Medical Center	Flint	Michigan
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida
United States	Northeast Georgia Heart Center	Gainesville	Georgia
United States	Texas Heart Rhythm	Houston	Texas
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Riverside Medical Center / Midwest Arrhythmia Consultants	Kankakee	Illinois
United States	Kettering Medical Center	Kettering	Ohio
United States	Cardiovascular Institute of the South	Lafayette	Louisiana
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	McAllen Medical Heart Hospital	McAllen	Texas
United States	CardioVascular Associates of Mesa	Mesa	Arizona
United States	Ball Memorial Hospital	Muncie	Indiana
United States	Columbia. University Medical Center/ NY Presbyterian Hospital	New York	New York
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	Peninsula Cardiology Associates	Salisbury	Maryland
United States	Cardiology Clinic of San Antonio	San Antonio	Texas
United States	Regional Cardiac Arrythmia	Washington	Pennsylvania
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Italy,  Netherlands,  Portugal,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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