Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
1064 participants
OBSERVATIONAL
2014-05-27
2021-05-18
Brief Summary
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Detailed Description
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All enrolled subjects will be contacted for follow-up at 30 days, 1, 2, 3, 4 and 5 years post index valve implantation. Follow-up visit at 1 year post valve implantation should be conducted via outpatient clinic visit. Follow-up visits at 30 days and 2 through 5 years may be conducted in person (preferred) and via telephone interview. Subjects who are not implanted with a Lotus Valve will be followed for safety through 30 days after the initial attempted index procedure.
Collection of safety events will include any serious adverse event (SAE) that led to death, serious adverse device effect (SADE), adverse device effect (ADE), unanticipated serious adverse device effect (USADE), and all Valve Academic Research Consortium (VARC) events regardless of seriousness and device relationship through 5 year follow-up.
The RESPOND study will be conducted in accordance with the International Organization for Standardization (ISO) 14155: 2011; ethical principles that have their origins in the Declaration of Helsinki; the relevant parts of the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practices (GCP); and pertinent individual country/state/local laws and regulations.
An additional cohort of approximately 50 subjects will be enrolled at up to 6 study centers in Europe after enrollment in the main cohort is completed to assess center-driven implantation technique with the commercially available Lotus Valve with Depth Guard technology.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lotus Valve
All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve.
Lotus Valve System
The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Lotus with Depth Guard
All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard.
Lotus Valve System
The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Interventions
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Lotus Valve System
The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Nicolas Van Mieghem, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Volkmar Falk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
German Heart Center Berlin
Locations
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Angiografia de Occidente S.A.
Cali, , Colombia
Fundacion Cardiovascular de Colombia
Floridablanca, , Colombia
Helsinki University Central Hospital/Meilahti Hospital
Helsinki, , Finland
Turku University Hospital
Turku, , Finland
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Krankenhaus d. Barmherzigen Brüder
Trier, Rhineland-Palatinate, Germany
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Vivantes Klinikum im Friedrichshain
Berlin, , Germany
Charité Campus Virchow Klinikum
Berlin, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
Herz- und Gefäß-Klinik Bonn
Bonn, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Herzzentrum Universitat Leipzig
Leipzig, , Germany
Deutsches Herzzentrum München
Munich, , Germany
University Hospital Munich
Munich, , Germany
Universitätsklinikum Rostock
Rostock, , Germany
HELIOS Clinic
Siegburg, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Rabin Medical Center
Petah Tikva, , Israel
IRCC Policlinico San Donato
Milan, Mi, Italy
Azienda Ospedaliera Universtitaria di Padova
Padua, PD, Italy
Azienda Ospedaliera Universtiatia Pisana (AOUP) Ospedale Cisanello
Pisa, PI, Italy
Ospedale San Raffaele
Milan, , Italy
Dept. of Cardiology Sint-Antonius ziekenhuis
Nieuwegein, EM, Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Waikato Hospital
Hamilton, , New Zealand
Haukeland universitetssjukehus
Bergen, , Norway
I Klinika Kardiologii Uniwersytetu Medycznego W Poznaiu
Poznan, , Poland
National Institute of Cardiology
Warsaw, , Poland
Hospital Universitario La Paz
Madrid, , Spain
Policlinica Gipuzkoa
San Sebastián, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
INSELSPITAL - Universitätsspital Bern
Bern, , Switzerland
John Radcliffe Infirmary Oxford II
Oxford, England, United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Leeds Teaching Hospitals NHS
Leeds, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Clinical Trials Practitioner
London, , United Kingdom
King's College Hospital London
London, , United Kingdom
Cardiovascular & Cell Sciences Research Institute
London, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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References
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Van Mieghem NM, Wohrle J, Hildick-Smith D, Bleiziffer S, Blackman DJ, Abdel-Wahab M, Gerckens U, Linke A, Ince H, Wenaweser P, Allocco DJ, Meredith IT, Falk V. Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice: The RESPOND Study and RESPOND Extension Cohort. JACC Cardiovasc Interv. 2019 Jan 14;12(1):38-49. doi: 10.1016/j.jcin.2018.10.052.
Falk V, Wohrle J, Hildick-Smith D, Bleiziffer S, Blackman DJ, Abdel-Wahab M, Gerckens U, Linke A, Ince H, Wenaweser P, Allocco DJ, Dawkins KD, Van Mieghem NM. Safety and efficacy of a repositionable and fully retrievable aortic valve used in routine clinical practice: the RESPOND Study. Eur Heart J. 2017 Dec 1;38(45):3359-3366. doi: 10.1093/eurheartj/ehx297.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TP6461
Identifier Type: -
Identifier Source: org_study_id