RESPOND Post Market Study

Aortic Valve Stenosis Clinical Trial

— RESPOND  

Official title:

RESPOND: Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031302
• Other study ID #: TP6461
• Status: Completed
• Start date: May 27, 2014
• Est. completion date: May 18, 2021

Study information

• Verified date: November 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1064
• Est. completion date: May 18, 2021
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Colombia	Angiografia de Occidente S.A.	Cali
Colombia	Fundacion Cardiovascular de Colombia	Floridablanca
Finland	Helsinki University Central Hospital/Meilahti Hospital	Helsinki
Finland	Turku University Hospital	Turku
Germany	Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH	Bad Segeberg
Germany	Charité Campus Virchow Klinikum	Berlin
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Herz- und Gefäß-Klinik Bonn	Bonn
Germany	Universitätsklinikum Bonn	Bonn	NRW
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	Krankenhaus d. Barmherzigen Brüder	Trier	Rheinland Pfalz
Germany	Universitätsklinikum Ulm	Ulm
Israel	Rabin Medical Center	Petach Tikva
Italy	IRCC Policlinico San Donato	Milan	Mi
Italy	Ospedale San Raffaele	Milano
Italy	Azienda Ospedaliera Universtitaria di Padova	Padova	PD
Italy	Azienda Ospedaliera Universtiatia Pisana (AOUP) Ospedale Cisanello	Pisa	PI
Netherlands	Dept. of Cardiology Sint-Antonius ziekenhuis	Nieuwegein	EM
Netherlands	Erasmus Medical Center	Rotterdam
New Zealand	Waikato Hospital	Hamilton
Norway	Haukeland universitetssjukehus	Bergen
Poland	I Klinika Kardiologii Uniwersytetu Medycznego W Poznaiu	Poznan
Poland	National Institute of Cardiology	Warsaw
Spain	Hospital Universitario La Paz	Madrid
Spain	Policlinica Gipuzkoa	San Sebastián
Sweden	Sahlgrenska University Hospital	Gothenburg
Switzerland	INSELSPITAL - Universitätsspital Bern	Bern
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Leeds Teaching Hospitals NHS	Leeds
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	Cardiovascular & Cell Sciences Research Institute	London
United Kingdom	Clinical Trials Practitioner	London
United Kingdom	King's College Hospital London	London
United Kingdom	John Radcliffe Infirmary Oxford II	Oxford	England
United Kingdom	New Cross Hospital	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Colombia,  Finland,  Germany,  Israel,  Italy,  Netherlands,  New Zealand,  Norway,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke	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 (as treated 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.	30 Days and 1 year
Secondary	In-hospital Mortality	In-hospital mortality till discharge	Duration of hospital stay, an expected average of 2 days
Secondary	Percentage of Participants With Events Included in the VARC Efficacy Composite Endpoint	The VARC efficacy composite at 1 year, including all-cause mortality; all stroke (disabling and non-disabling); re-hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); and prosthetic valve-related dysfunction (mean aortic valve gradient =20 mmHg, effective orifice area (EOA) =0.9-1.1 cm2 and/or Doppler velocity index (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve aortic regurgitation)	1 Year
Secondary	Patients With Valve Safety Composite Outcomes at 1 Year	Time related valve safety composite outcomes at 1 year, including structural valve deterioration (valve-related dysfunction requiring repeat procedure [TAVI or SAVR]); prosthetic valve endocarditis; prosthetic valve thrombosis; thromboembolic events (e.g. stroke) and VARC bleeding, unless clearly unrelated to valve therapy based on investigator assessment (e.g. trauma).; 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	Patients With VARC Safety Composite Outcomes at 30 Days	Patients with VARC safety composite outcomes at 30 days. VARC safety composite endpoints are defined as: Life-threatening bleeding; Acute kidney injury-Stage 2 or 3 (including renal replacement therapy); Coronary artery obstruction requiring intervention; Major vascular complication; Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR); New conduction disturbances (LBBB, AVB, RBBB) and need for permanent pacemaker implantation	30 Days
Secondary	Patients With Moderate and Severe Paravalvular Aortic Valve Regurgitation	Grade of paravalvular aortic valve regurgitation pre-discharge as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory. The moderate and severe paravalvular aortic regurgitation rate will be compared to a pre-specified performance goal.; We don't have a powered analysis for the PVL for RESPOND study.	Duration of hospital stay, an expected average of 2 days