Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
NCT ID: NCT03075215
Last Updated: 2023-10-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2044 participants
OBSERVATIONAL
2017-04-14
2021-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
NCT03089281
Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)
NCT00677014
Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
NCT03257436
Cardiac Strains for Optimization of CRT in Non-Responders
NCT03803826
Triple-site Biventricular Stimulation in the Optimization of CRT
NCT02350842
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jose-Ignacio Garcia-Bolao, PhD, FESC
Role: PRINCIPAL_INVESTIGATOR
Clinica Universidad de Navarra
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Providence Alaska Medical Center
Anchorage, Alaska, United States
CardioVascular Associates of Mesa
Mesa, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Comprehensive Cardiovascular Medical Group
Bakersfield, California, United States
VA Loma Linda Healthcare System
Loma Linda, California, United States
Western Connecticut Health Network/ Danbury Hospital
Danbury, Connecticut, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States
Northeast Georgia Heart Center
Gainesville, Georgia, United States
The University of Illinois Medical Center
Chicago, Illinois, United States
Riverside Medical Center / Midwest Arrhythmia Consultants
Kankakee, Illinois, United States
Ball Memorial Hospital
Muncie, Indiana, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Cardiovascular Institute of the South
Lafayette, Louisiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Peninsula Cardiology Associates
Salisbury, Maryland, United States
Hurley Medical Center
Flint, Michigan, United States
Summit Medical Group, P.A.
Berkeley Heights, New Jersey, United States
Trinity Medical WNY,PC
Buffalo, New York, United States
Columbia. University Medical Center/ NY Presbyterian Hospital
New York, New York, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
St. Alexius Medical Center
Bismarck, North Dakota, United States
Kettering Medical Center
Kettering, Ohio, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Regional Cardiac Arrythmia
Washington, Pennsylvania, United States
Texas Heart Rhythm
Houston, Texas, United States
McAllen Medical Heart Hospital
McAllen, Texas, United States
Cardiology Clinic of San Antonio
San Antonio, Texas, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
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, Australia
Landeskrankenhaus Salzburg Universitätsklinikum der PMU
Salzburg, , Austria
Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik für Innere Medizin II
Vienna, , Austria
Krankenhaus Nord
Vienna, , Austria
Virga Jesse Ziekenhuis
Hasselt, , Belgium
UCL de Mont Godinne
Yvoir, , Belgium
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
Montreal, , Canada
Faculty Hospital U sv Anny
Brno, , Czechia
Kardiologicke centrum AGEL
Pardubice, , Czechia
IKEM - Institut klinicke a experimentalni mediciny
Prague, , Czechia
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
CH Belfort Montbeliard
Trévenans, , France
Hôpital Nord Franche-Comté
Trévenans, , France
Centre Hospitalier de Valence
Valence, , France
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
Mönchengladbach, , Germany
Deutsches Herzzentrum Muenchen
Munich, , Germany
Krankenhaus Martha Maria
Nuremberg, , Germany
Klinikum Oldenburg AoR
Oldenburg, , Germany
Klinikum der Universitaet Regensburg
Regensburg, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , 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, , Italy
Ospedale San Francesco
Nuoro, , Italy
Azienda Ospedaliera di Padova
Padua, , 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, , Italy
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, , Netherlands
Hospital da Senhora da Oliveira
Guimarães, , Portugal
Hospital Santa Maria (Centro Hospitalar de Lisboa Norte)
Lisbon, , Portugal
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, , Portugal
The National Institute of Cardiovascular Diseases
Bratislava, , Slovakia
Hospital General Universitario
Alicante, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Bellvitge
Barcelona, , Spain
Hospital General de Ciudad Real
Ciudad Real, , Spain
Hospital Virgen De Las Nieves
Granada, , Spain
Hospital Infanta Leonor
Madrid, , Spain
Hospital Clinico San Carlos
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
Seville, , Spain
Hospital nuestra senora del prado
Talavera de la Reina, , Spain
CHUV Lausanne
Lausanne, , Switzerland
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
Papworth Hospital
Cambridge, , 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
Manchester Royal Infirmary
Manchester, , United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C1949
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.