RESPOND Post Market Study

Completed

Conditions: Aortic Valve Stenosis

Interventions: Device: Lotus Valve System

Registration Number: NCT02031302

Lead Sponsor: Boston Scientific Corporation

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1064

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lotus with Depth Guard	Lotus Valve System	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	Lotus Valve System	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.

Primary Outcome Measures

Name	Time	Method
All-cause Mortality	1 Year	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.

Secondary Outcome Measures

Name	Time	Method
Patients With VARC Safety Composite Outcomes at 30 Days	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
Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke	30 Days and 1 year	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.
In-hospital Mortality	Duration of hospital stay, an expected average of 2 days	In-hospital mortality till discharge
Patients With Valve Safety Composite Outcomes at 1 Year	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.
Percentage of Participants With Events Included in the VARC Efficacy Composite Endpoint	1 Year	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)
Patients With Moderate and Severe Paravalvular Aortic Valve Regurgitation	Duration of hospital stay, an expected average of 2 days	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.

Trial Locations

Locations (41): 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, NRW, Germany
Krankenhaus d. Barmherzigen Brüder
🇩🇪
Trier, Rheinland Pfalz, 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
Scroll for more (31 remaining)
Angiografia de Occidente S.A.
🇨🇴Cali, Colombia