Clinical trial NCT02031302: RESPOND Post Market Study
Official title: RESPOND: Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: Lotus
Valve
Real world
Aortic stenosis
High risk
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 1064
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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 will be evaluated for enrollment in this study.

Brief summary: The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

Detailed description: The RESPOND study is a prospective, open label, single arm, multi-center, observational post market study designed to collect real world clinical and device performance outcomes data of the commercially available Lotus Valve used in routine clinical practice for the treatment of severe calcific aortic stenosis. Approximately 1000 real-world, consecutive subjects will be enrolled at up to 50 study centers in Europe, Asia Pacific and Central/South America.

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.

Eligibility criteria: Subjects will be evaluated for eligibility by the clinical center's heart team per the local standard of practice in accordance with the Directions for Use.

Primary outcomes:
measure: All-cause Mortality
timeFrame: 30 Days
measure: All-cause Mortality
timeFrame: 1 Year
Secondary outcomes:
measure: Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke
timeFrame: 30 Days and 1 year
measure: In-hospital Mortality
timeFrame: Duration of hospital stay, an expected average of 2 days
measure: Percentage of Participants With Events Included in the VARC Efficacy Composite Endpoint
timeFrame: 1 Year
measure: Patients With Valve Safety Composite Outcomes at 1 Year
timeFrame: 1 Year
measure: Patients With VARC Safety Composite Outcomes at 30 Days
timeFrame: 30 Days
measure: Patients With Moderate and Severe Paravalvular Aortic Valve Regurgitation
timeFrame: Duration of hospital stay, an expected average of 2 days
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Angiografia de Occidente S.A.
city: Floridablanca
country: Colombia
facility: Fundacion Cardiovascular de Colombia
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital/Meilahti Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: NRW
city: Trier
country: Germany
facility: Krankenhaus d. Barmherzigen Brüder
state: Rheinland Pfalz
city: Bad Segeberg
country: Germany
facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Berlin
country: Germany
facility: Charité Campus Virchow Klinikum
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bonn
country: Germany
facility: Herz- und Gefäß-Klinik Bonn
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Leipzig
country: Germany
facility: Herzzentrum Universitat Leipzig
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Munich
country: Germany
facility: University Hospital Munich
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock
city: Siegburg
country: Germany
facility: HELIOS Clinic
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Milan
country: Italy
facility: IRCC Policlinico San Donato
state: Mi
city: Padova
country: Italy
facility: Azienda Ospedaliera Universtitaria di Padova
state: PD
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universtiatia Pisana (AOUP) Ospedale Cisanello
state: PI
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Nieuwegein
country: Netherlands
facility: Dept. of Cardiology Sint-Antonius ziekenhuis
state: EM
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Bergen
country: Norway
facility: Haukeland universitetssjukehus
city: Poznań
country: Poland
facility: I Klinika Kardiologii Uniwersytetu Medycznego W Poznaiu
city: Warsaw
country: Poland
facility: National Institute of Cardiology
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: San Sebastián
country: Spain
facility: Policlinica Gipuzkoa
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Bern
country: Switzerland
facility: INSELSPITAL - Universitätsspital Bern
city: Oxford
country: United Kingdom
facility: John Radcliffe Infirmary Oxford II
state: England
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: Clinical Trials Practitioner
city: London
country: United Kingdom
facility: King's College Hospital London
city: London
country: United Kingdom
facility: Cardiovascular & Cell Sciences Research Institute
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Erasmus Medical Center
name: Nicolas Van Mieghem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: German Heart Center Berlin
name: Volkmar Falk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.