SMART Registry: Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03075215
Collaborator
(none)
2,044
139
55.1
14.7
0.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Actual Enrollment
:
2044 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)
Actual Study Start Date
:
Apr 14, 2017
Actual Primary Completion Date
:
Nov 15, 2021
Actual Study Completion Date
:
Nov 15, 2021
Outcome Measures
Primary Outcome Measures
- CRT Response Rate [12 months]
Clinical Composite Score
Secondary Outcome Measures
- NG4 PG Related Complication Free rate [36 months]
Complication Free rate
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
| 2 | CardioVascular Associates of Mesa | Mesa | Arizona | United States | 85206 |
| 3 | Arrhythmia Research Group | Jonesboro | Arkansas | United States | 72401 |
| 4 | Comprehensive Cardiovascular Medical Group | Bakersfield | California | United States | 93309 |
| 5 | VA Loma Linda Healthcare System | Loma Linda | California | United States | 92357 |
| 6 | Western Connecticut Health Network/ Danbury Hospital | Danbury | Connecticut | United States | 06810 |
| 7 | Bay Area Cardiology Associates, P.A. | Brandon | Florida | United States | 33511 |
| 8 | North Florida/South Georgia Veterans Health System | Gainesville | Florida | United States | 32608 |
| 9 | Northeast Georgia Heart Center | Gainesville | Georgia | United States | 30501 |
| 10 | The University of Illinois Medical Center | Chicago | Illinois | United States | 60612 |
| 11 | Riverside Medical Center / Midwest Arrhythmia Consultants | Kankakee | Illinois | United States | 60901 |
| 12 | Ball Memorial Hospital | Muncie | Indiana | United States | 47303 |
| 13 | Midwest Cardiovascular Research Foundation | Davenport | Iowa | United States | 52803 |
| 14 | Cardiovascular Institute of the South | Lafayette | Louisiana | United States | 70503 |
| 15 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 16 | Peninsula Cardiology Associates | Salisbury | Maryland | United States | 21804 |
| 17 | Hurley Medical Center | Flint | Michigan | United States | 48532 |
| 18 | Summit Medical Group, P.A. | Berkeley Heights | New Jersey | United States | 07922 |
| 19 | Trinity Medical WNY,PC | Buffalo | New York | United States | 14215 |
| 20 | Columbia. University Medical Center/ NY Presbyterian Hospital | New York | New York | United States | 10032 |
| 21 | New Hanover Regional Medical Center | Wilmington | North Carolina | United States | 28401 |
| 22 | St. Alexius Medical Center | Bismarck | North Dakota | United States | 58501 |
| 23 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
| 24 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 25 | Regional Cardiac Arrythmia | Washington | Pennsylvania | United States | 15301 |
| 26 | Texas Heart Rhythm | Houston | Texas | United States | 77074 |
| 27 | McAllen Medical Heart Hospital | McAllen | Texas | United States | 78503 |
| 28 | Cardiology Clinic of San Antonio | San Antonio | Texas | United States | 78229 |
| 29 | Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | United States | 23249 |
| 30 | Flinders Medical Centre | Bedford Park | South Australia | Australia | 5042 |
| 31 | Monash Medical Centre | Clayton | Victoria | Australia | 3168 |
| 32 | Peninsula Health | Frankston | Victoria | Australia | 3199 |
| 33 | Barwon Health Myers House Ground Floor Geelong Hospital | Geelong | Victoria | Australia | 3220 |
| 34 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 35 | Landeskrankenhaus Salzburg Universitätsklinikum der PMU | Salzburg | Austria | 05020 | |
| 36 | Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik für Innere Medizin II | Vienna | Austria | ||
| 37 | Krankenhaus Nord | Vienna | Austria | ||
| 38 | Virga Jesse Ziekenhuis | Hasselt | Belgium | 3500 | |
| 39 | UCL de Mont Godinne | Yvoir | Belgium | 5530 | |
| 40 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 41 | Fleurimont Hospital (CHU de Sherbrooke) | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 42 | Royal Alexandra Hospital - Cardiology Research CK Hui Heart Centre | Edmonton | Canada | T5H 3V9 | |
| 43 | Hôpital du Sacré-Cœur de Montréal | Montréal | Canada | H4J 1C5 | |
| 44 | Faculty Hospital U sv Anny | Brno | Czechia | ||
| 45 | Kardiologicke centrum AGEL | Pardubice | Czechia | ||
| 46 | IKEM - Institut klinicke a experimentalni mediciny | Praha | Czechia | 14021 | |
| 47 | Centre Hospitalier de la Cote Basque | Bayonne | France | 64100 | |
| 48 | CHU de Besancon | Besançon | France | 25030 | |
| 49 | CHU Brest - Hopital Cavale Blanche | Brest | France | 29200 | |
| 50 | Ch de Cannes | Cannes | France | ||
| 51 | APHP CHU Henri Mondor | Créteil | France | 94010 | |
| 52 | CHU Dijon | Dijon | France | 21000 | |
| 53 | Hopital Privé de Clairval | Marseille | France | ||
| 54 | Hospital Prive Jacques Cartier | Massy | France | 91300 | |
| 55 | CH Annecy Genevois | Metz-Tessy | France | 74370 | |
| 56 | Clinique du Millénaire | Montpellier | France | 34000 | |
| 57 | NCN Nouvelles Cliniques Nantaises | Nantes | France | 44277 | |
| 58 | CHU Nimes Cedex | Nîmes | France | 30029 | |
| 59 | Chru Orleans | Orléans | France | 45100 | |
| 60 | CHG de Pau | Pau | France | 64000 | |
| 61 | CHU de Poitiers | Poitiers | France | 86021 | |
| 62 | CHU Amiens hopital sud | Salouël | France | 80480 | |
| 63 | Clinique Pasteur | Toulouse | France | 31000 | |
| 64 | CHU TOURS - Hospital Trousseau | Tours | France | 37170 | |
| 65 | Clinique Saint Gatien | Tours | France | ||
| 66 | Hôpital Nord Franche-Comté | Trevenans | France | ||
| 67 | CH Belfort Montbeliard | Trévenans | France | 90400 | |
| 68 | Centre Hospitalier de Valence | Valence | France | 26000 | |
| 69 | Charite Universitätsmedizin Berlin CBF | Berlin | Germany | 12203 | |
| 70 | Deutsches Herzzentrum Berlin | Berlin | Germany | 13353 | |
| 71 | Klinikum Links der Weser-Elektrophysiologie Bremen | Bremen | Germany | 28277 | |
| 72 | Augusta Krankenhaus | Düsseldorf | Germany | 40472 | |
| 73 | Universitaetsklinikum Duesseldorf | Düsseldorf | Germany | ||
| 74 | Universitares Herzentrum Hamburg/Universitaetsklinik Eppendorf | Hamburg | Germany | 20251 | |
| 75 | Universitaetsklinikum Heidelberg | Heidelberg | Germany | 69120 | |
| 76 | Oberhavel Kliniken | Hennigsdorf | Germany | 16761 | |
| 77 | Marien Hospital Herne | Herne | Germany | 44627 | |
| 78 | Universitätsklinikum Leipzig | Leipzig | Germany | 04103 | |
| 79 | Klinikum Leverkusen gGmbH | Leverkusen | Germany | 51375 | |
| 80 | Universitätsklinikum Schleswig-Holstein | Lübeck | Germany | 23538 | |
| 81 | Universität Mainz zentrum fur kardiologie | Mainz | Germany | 55131 | |
| 82 | Klinikum Mannheim GMBH | Mannheim | Germany | 68167 | |
| 83 | Kliniken Maria-Hilf GmbH | Monchengladbach | Germany | ||
| 84 | Deutsches Herzzentrum Muenchen | Munich | Germany | 80636 | |
| 85 | Krankenhaus Martha Maria | Nürnberg | Germany | 90491 | |
| 86 | Klinikum Oldenburg AoR | Oldenburg | Germany | 26133 | |
| 87 | Klinikum der Universitaet Regensburg | Regensburg | Germany | 93053 | |
| 88 | Universitaetsklinikum Wuerzburg | Würzburg | Germany | 97080 | |
| 89 | Voc Cardiologia Ospedaliera Polocino di Bari | Bari | Italy | ||
| 90 | Magna Graecia University AUO Mater Domini di Catanzaro | Catanzaro | Italy | ||
| 91 | Azienda Ospedaliero - Universitaria di Ferrara | Ferrara | Italy | ||
| 92 | Ospedale Vito Fazzi | Lecce | Italy | ||
| 93 | Federico II University of Naples | Naples | Italy | ||
| 94 | Ospedale Monaldi | Napoli | Italy | 80021 | |
| 95 | Ospedale San Francesco | Nuoro | Italy | ||
| 96 | Azienda Ospedaliera di Padova | Padova | Italy | ||
| 97 | A.O.U. Policlinico Paolo Giaccone | Palmero | Italy | ||
| 98 | Ospedale Maria Paternò Arezzo | Ragusa | Italy | ||
| 99 | Fondazione Policlinico Universitario Agostino Gemelli | Rome | Italy | ||
| 100 | Ospedale San Pietro Fatebenefratelli | Rome | Italy | ||
| 101 | Policlinico Casilino | Rome | Italy | ||
| 102 | Ospedale Santa Maria della Misericordia di Rovigo | Rovigo | Italy | ||
| 103 | Azienda Socio-Sanitaria Territoriale dei Sette Laghi | Varese | Italy | 21000 | |
| 104 | Noordwest Ziekenhuisgroep Alkmaar | Alkmaar | Netherlands | 1815 JD | |
| 105 | Amphia Ziekenhuis | Breda | Netherlands | 4818 CK | |
| 106 | Medisch Spectrum Twente | Enschede | Netherlands | 7512 KZ | |
| 107 | UMC St. Radboud | Nijmegen | Netherlands | 6525 GA | |
| 108 | Erasmus Medical Centre | Rotterdam | Netherlands | 3015CE | |
| 109 | Maasstad Hospital | Rotterdam | Netherlands | 3079 DZ | |
| 110 | Hospital da Senhora da Oliveira | Guimarães | Portugal | ||
| 111 | Hospital Santa Maria (Centro Hospitalar de Lisboa Norte) | Lisboa | Portugal | ||
| 112 | Centro Hospitalar do Porto - Hospital de Santo Antonio | Porto | Portugal | 4099-001 | |
| 113 | The National Institute of Cardiovascular Diseases | Bratislava | Slovakia | 83348 | |
| 114 | Hospital General Universitario | Alicante | Spain | ||
| 115 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
| 116 | Hospital Bellvitge | Barcelona | Spain | ||
| 117 | Hospital General de Ciudad Real | Ciudad Real | Spain | 13005 | |
| 118 | Hospital Virgen De Las Nieves | Granada | Spain | ||
| 119 | Hospital Infanta Leonor | Madrid | Spain | 28031 | |
| 120 | Hospital Clinico San Carlos | Madrid | Spain | 28040 | |
| 121 | Hospital La Paz | Madrid | Spain | 28046 | |
| 122 | Clinica Universidad de Navarra | Pamplona | Spain | ||
| 123 | Hospital Universitario de Canarias | Santa Cruz De Tenerife | Spain | 38320 | |
| 124 | Hospital Universitario Marques De Valdecilla | Santander | Spain | 39011 | |
| 125 | Hospital Virgen Macarena | Sevilla | Spain | ||
| 126 | Hospital nuestra senora del prado | Talavera de la Reina | Spain | 45600 | |
| 127 | CHUV Lausanne | Lausanne | Switzerland | CH-1011 | |
| 128 | Basildon and Thurrock University Hospitals NHS Foundation Trust | Basildon | Essex | United Kingdom | SS16 5NL |
| 129 | Belfast City Hospital | Belfast | Northern Ireland | United Kingdom | BT9 7AB |
| 130 | Blackpool Teaching Hospitals NHS Foundation Trust' | Blackpool | United Kingdom | ||
| 131 | Bristol Heart Institute | Bristol | United Kingdom | ||
| 132 | Papworth Hospital | Cambridge | United Kingdom | CB23 3RE | |
| 133 | Addenbrookes Hospital | Cambridge | United Kingdom | ||
| 134 | Golden Jubilee National Hospital | Glasgow | United Kingdom | ||
| 135 | LHCH (Liverpool Heart and Chest Hospital) | Liverpool | United Kingdom | ||
| 136 | St Bartholomews Hospital | London | United Kingdom | EC1A 7BE | |
| 137 | Manchester Royal Infirmary | Manchester | United Kingdom | ||
| 138 | Northampton General Hospital | Northampton | United Kingdom | NN1 5BD | |
| 139 | Derriford Hospital | Plymouth | United Kingdom |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Jose-Ignacio Garcia-Bolao, PhD, FESC, Clinica Universidad de Navarra
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT03075215
Other Study ID Numbers:
- C1949
First Posted:
Mar 9, 2017
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms: