Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
- Conditions
- Heart Failure
- Registration Number
- NCT03075215
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2044
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications 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.CRT Response Rate 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."
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (139)
Peninsula Health
🇦🇺Frankston, Victoria, Australia
Krankenhaus Nord
🇦🇹Vienna, Austria
Centro Hospitalar do Porto - Hospital de Santo Antonio
🇵🇹Porto, Portugal
Hunter Holmes McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Barwon Health Myers House Ground Floor Geelong Hospital
🇦🇺Geelong, Victoria, Australia
Virga Jesse Ziekenhuis
🇧🇪Hasselt, Belgium
UCL de Mont Godinne
🇧🇪Yvoir, Belgium
Augusta Krankenhaus
🇩🇪Düsseldorf, Germany
Universitares Herzentrum Hamburg/Universitaetsklinik Eppendorf
🇩🇪Hamburg, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universität Mainz zentrum fur kardiologie
🇩🇪Mainz, Germany
Klinikum Leverkusen gGmbH
🇩🇪Leverkusen, Germany
Oberhavel Kliniken
🇩🇪Hennigsdorf, Germany
Marien Hospital Herne
🇩🇪Herne, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Klinikum der Universitaet Regensburg
🇩🇪Regensburg, Germany
Hospital General de Ciudad Real
🇪🇸Ciudad Real, Spain
Basildon and Thurrock University Hospitals NHS Foundation Trust
🇬🇧Basildon, Essex, United Kingdom
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
Western Connecticut Health Network/ Danbury Hospital
🇺🇸Danbury, Connecticut, United States
Cardiology Clinic of San Antonio
🇺🇸San Antonio, Texas, United States
The University of Illinois Medical Center
🇺🇸Chicago, Illinois, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Ospedale San Francesco
🇮🇹Nuoro, Italy
Ospedale Monaldi
🇮🇹Napoli, Italy
Ospedale Maria Paternò Arezzo
🇮🇹Ragusa, Italy
Ospedale Santa Maria della Misericordia di Rovigo
🇮🇹Rovigo, Italy
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
CardioVascular Associates of Mesa
🇺🇸Mesa, Arizona, United States
VA Loma Linda Healthcare System
🇺🇸Loma Linda, California, United States
Comprehensive Cardiovascular Medical Group
🇺🇸Bakersfield, California, United States
North Florida/South Georgia Veterans Health System
🇺🇸Gainesville, Florida, United States
Riverside Medical Center / Midwest Arrhythmia Consultants
🇺🇸Kankakee, Illinois, United States
Bay Area Cardiology Associates, P.A.
🇺🇸Brandon, Florida, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Northeast Georgia Heart Center
🇺🇸Gainesville, Georgia, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Peninsula Cardiology Associates
🇺🇸Salisbury, Maryland, United States
Midwest Cardiovascular Research Foundation
🇺🇸Davenport, Iowa, United States
Cardiovascular Institute of the South
🇺🇸Lafayette, Louisiana, United States
Trinity Medical WNY,PC
🇺🇸Buffalo, New York, United States
Summit Medical Group, P.A.
🇺🇸Berkeley Heights, New Jersey, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Columbia. University Medical Center/ NY Presbyterian Hospital
🇺🇸New York, New York, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Texas Heart Rhythm
🇺🇸Houston, Texas, United States
Regional Cardiac Arrythmia
🇺🇸Washington, Pennsylvania, United States
McAllen Medical Heart Hospital
🇺🇸McAllen, Texas, United States
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Landeskrankenhaus Salzburg Universitätsklinikum der PMU
🇦🇹Salzburg, Austria
Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik für Innere Medizin II
🇦🇹Vienna, Austria
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Fleurimont Hospital (CHU de Sherbrooke)
🇨🇦Sherbrooke, Quebec, Canada
Royal Alexandra Hospital - Cardiology Research CK Hui Heart Centre
🇨🇦Edmonton, Canada
Hôpital du Sacré-Cœur de Montréal
🇨🇦Montréal, Canada
Faculty Hospital U sv Anny
🇨🇿Brno, Czechia
Kardiologicke centrum AGEL
🇨🇿Pardubice, Czechia
Centre Hospitalier de la Cote Basque
🇫🇷Bayonne, France
IKEM - Institut klinicke a experimentalni mediciny
🇨🇿Praha, Czechia
CHU de Besancon
🇫🇷Besançon, France
CHU Brest - Hopital Cavale Blanche
🇫🇷Brest, France
APHP CHU Henri Mondor
🇫🇷Créteil, France
CHU Dijon
🇫🇷Dijon, France
Ch de Cannes
🇫🇷Cannes, France
Hospital Prive Jacques Cartier
🇫🇷Massy, France
Hopital Privé de Clairval
🇫🇷Marseille, France
CH Annecy Genevois
🇫🇷Metz-Tessy, France
Clinique du Millénaire
🇫🇷Montpellier, France
NCN Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
Chru Orleans
🇫🇷Orléans, France
CHU Nimes Cedex
🇫🇷Nîmes, France
CHG de Pau
🇫🇷Pau, France
CHU Amiens hopital sud
🇫🇷Salouël, France
CHU de Poitiers
🇫🇷Poitiers, France
CHU TOURS - Hospital Trousseau
🇫🇷Tours, France
Clinique Pasteur
🇫🇷Toulouse, France
Clinique Saint Gatien
🇫🇷Tours, France
Hôpital Nord Franche-Comté
🇫🇷Trevenans, France
CH Belfort Montbeliard
🇫🇷Trévenans, France
Charite Universitätsmedizin Berlin CBF
🇩🇪Berlin, Germany
Centre Hospitalier de Valence
🇫🇷Valence, France
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
A.O.U. Policlinico Paolo Giaccone
🇮🇹Palmero, Italy
Klinikum Links der Weser-Elektrophysiologie Bremen
🇩🇪Bremen, Germany
Universitaetsklinikum Duesseldorf
🇩🇪Düsseldorf, Germany
Kliniken Maria-Hilf GmbH
🇩🇪Monchengladbach, Germany
Klinikum Mannheim GMBH
🇩🇪Mannheim, Germany
Deutsches Herzzentrum Muenchen
🇩🇪Munich, Germany
Krankenhaus Martha Maria
🇩🇪Nürnberg, Germany
Klinikum Oldenburg AoR
🇩🇪Oldenburg, Germany
Magna Graecia University AUO Mater Domini di Catanzaro
🇮🇹Catanzaro, Italy
Universitaetsklinikum Wuerzburg
🇩🇪Würzburg, Germany
Voc Cardiologia Ospedaliera Polocino di Bari
🇮🇹Bari, Italy
Azienda Ospedaliero - Universitaria di Ferrara
🇮🇹Ferrara, Italy
Ospedale Vito Fazzi
🇮🇹Lecce, Italy
Federico II University of Naples
🇮🇹Naples, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Rome, Italy
Hospital da Senhora da Oliveira
🇵🇹Guimarães, Portugal
Ospedale San Pietro Fatebenefratelli
🇮🇹Rome, Italy
Policlinico Casilino
🇮🇹Rome, Italy
Noordwest Ziekenhuisgroep Alkmaar
🇳🇱Alkmaar, Netherlands
Azienda Socio-Sanitaria Territoriale dei Sette Laghi
🇮🇹Varese, Italy
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
UMC St. Radboud
🇳🇱Nijmegen, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Erasmus Medical Centre
🇳🇱Rotterdam, Netherlands
Maasstad Hospital
🇳🇱Rotterdam, Netherlands
Hospital Santa Maria (Centro Hospitalar de Lisboa Norte)
🇵🇹Lisboa, Portugal
Hospital Bellvitge
🇪🇸Barcelona, Spain
Hospital General Universitario
🇪🇸Alicante, Spain
The National Institute of Cardiovascular Diseases
🇸🇰Bratislava, Slovakia
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Infanta Leonor
🇪🇸Madrid, Spain
Hospital Virgen De Las Nieves
🇪🇸Granada, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitario Marques De Valdecilla
🇪🇸Santander, Spain
Hospital Universitario de Canarias
🇪🇸Santa Cruz De Tenerife, Spain
Hospital nuestra senora del prado
🇪🇸Talavera de la Reina, Spain
CHUV Lausanne
🇨ðŸ‡Lausanne, Switzerland
Bristol Heart Institute
🇬🇧Bristol, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust'
🇬🇧Blackpool, United Kingdom
Papworth Hospital
🇬🇧Cambridge, United Kingdom
Belfast City Hospital
🇬🇧Belfast, Northern Ireland, 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, United Kingdom
Northampton General Hospital
🇬🇧Northampton, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Hospital La Paz
🇪🇸Madrid, Spain