RESPOND Post Market Study

NCT02031302 | Completed Results

• 1 other identifier: TP6461
• Study Type: observational
• Target: 1,064
• Locations: 13 countries
• Sites: 41

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.

Conditions

Aortic Valve Stenosis

Keywords

Lotus; Valve; Real world; Aortic stenosis; High risk

Outcome Measures

Primary Outcomes (2)

• All-cause Mortality

  The primary endpoint is all-cause mortality at 30 days after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted). All-cause mortality at 30 days after the implant procedure will be compared to a pre-specified performance goal.

  30 Days

• All-cause Mortality

  The primary endpoint is all-cause mortality at 1 year after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted). A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 4 additional patients died but were not treated with the study valve system (ITT population). The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.

  1 Year

Secondary Outcomes (6)

• Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke

  30 Days and 1 year

• In-hospital Mortality

  Duration of hospital stay, an expected average of 2 days

• Percentage of Participants With Events Included in the VARC Efficacy Composite Endpoint

  1 Year

• Patients With Valve Safety Composite Outcomes at 1 Year

  1 Year

• Patients With VARC Safety Composite Outcomes at 30 Days

  30 Days

Study Arms (2)

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.

Device: Lotus Valve System

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.

Device: Lotus Valve System

Interventions

Lotus Valve System DEVICE

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 Valve; Lotus with Depth Guard

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (41)

Angiografia de Occidente S.A.

Cali, Colombia

Location

Fundacion Cardiovascular de Colombia

Floridablanca, Colombia

Location

Helsinki University Central Hospital/Meilahti Hospital

Helsinki, 00290 HUS, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Krankenhaus d. Barmherzigen Brüder

Trier, Rhineland-Palatinate, 76133, Germany

Location

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Charité Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 24105, Germany

Location

Herz- und Gefäß-Klinik Bonn

Bonn, 53113, Germany

Location

Asklepios Klinik St. Georg

Hamburg, Germany

Location

Herzzentrum Universitat Leipzig

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum München

Munich, 80636, Germany

Location

University Hospital Munich

Munich, 81377, Germany

Location

Universitätsklinikum Rostock

Rostock, 10249, Germany

Location

HELIOS Clinic

Siegburg, 53721, Germany

Location

Universitätsklinikum Ulm

Ulm, 69120, Germany

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

IRCC Policlinico San Donato

Milan, Mi, 20149, Italy

Location

Azienda Ospedaliera Universtitaria di Padova

Padua, PD, 35100, Italy

Location

Azienda Ospedaliera Universtiatia Pisana (AOUP) Ospedale Cisanello

Pisa, PI, 56124, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Dept. of Cardiology Sint-Antonius ziekenhuis

Nieuwegein, EM, 3430, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

Haukeland universitetssjukehus

Bergen, 5021, Norway

Location

I Klinika Kardiologii Uniwersytetu Medycznego W Poznaiu

Poznan, 61-848, Poland

Location

National Institute of Cardiology

Warsaw, 04-628, Poland

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Policlinica Gipuzkoa

San Sebastián, 20011, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

INSELSPITAL - Universitätsspital Bern

Bern, CH-3010, Switzerland

Location

John Radcliffe Infirmary Oxford II

Oxford, England, OX3 9DU, United Kingdom

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Leeds Teaching Hospitals NHS

Leeds, LS1 3EX, United Kingdom

Location

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

Clinical Trials Practitioner

London, SE1 7EH, United Kingdom

Location

King's College Hospital London

London, SE5 9RS, United Kingdom

Location

Cardiovascular & Cell Sciences Research Institute

London, SW17 0QT, United Kingdom

Location

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 30621976 DERIVED

• 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.

  PMID: 28651336 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Blessie Concepcion, Director Clinical Trials
• Organization: Boston Scientific Corp.

Blessie.Concepcion@bsci.com

408-385-8604

Study Officials

• Nicolas Van Mieghem, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Volkmar Falk, MD, PhD

  German Heart Center Berlin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 9, 2014
• Study Start: May 27, 2014
• Primary Completion: April 4, 2017
• Study Completion: May 18, 2021
• Last Updated: November 19, 2021
• Results First Posted: November 12, 2019

Record last verified: 2021-11

Locations

ES (2); PL (2); CO (2); FI (2); IL (1); IT (4); NZ (1); DE (14); NL (2); NO (1); SE (1); CH (1); GB (8)