RESPOND Post Market Study
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||RESPOND: Repositionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes|
- All-cause mortality [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]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.
- All-cause mortality [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]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).
- Safety composite of all-cause mortality and disabling stroke [ Time Frame: 30 Days and 1 year ] [ Designated as safety issue: Yes ]
- In-hospital mortality [ Time Frame: Duration of hospital stay, an expected average of 2 days ] [ Designated as safety issue: Yes ]
- The VARC efficacy composite [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]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)
- Time related valve safety composite [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]Time related valve safety composite 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 VARC safety composite [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
Clinical endpoints at 30 days defined according to current VARC guidelines:
- 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
- Grade of paravalvular aortic valve regurgitation [ Time Frame: Duration of hospital stay, an expected average of 2 days ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||January 2021|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
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
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02031302
|Contact: Andrey Nersesovfirstname.lastname@example.org|
|Erasmus Medical Center||Recruiting|
|Principal Investigator: Nicolas Van Mieghem, MD|
|Principal Investigator:||Nicolas Van Mieghem, MD||Erasmus Medical Center Rotterdam|
|Principal Investigator:||Volkmar Falk, MD, PhD||German Heart Center Berlin|