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RESPOND Post Market Study (RESPOND)

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ClinicalTrials.gov Identifier: NCT02031302
Recruitment Status : Active, not recruiting
First Posted : January 9, 2014
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date January 6, 2014
First Posted Date January 9, 2014
Last Update Posted Date March 15, 2019
Actual Study Start Date May 27, 2014
Actual Primary Completion Date April 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2014)
  • All-cause mortality [ Time Frame: 30 Days ]
    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 ]
    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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02031302 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 8, 2014)
  • Safety composite of all-cause mortality and disabling stroke [ Time Frame: 30 Days and 1 year ]
  • In-hospital mortality [ Time Frame: Duration of hospital stay, an expected average of 2 days ]
  • The VARC efficacy composite [ Time Frame: 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)
  • Time related valve safety composite [ Time Frame: 1 Year ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title RESPOND Post Market Study
Official Title RESPOND: Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Device: Lotus Valve System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 23, 2017)
1064
Original Estimated Enrollment
 (submitted: January 8, 2014)
1000
Estimated Study Completion Date May 2021
Actual Primary Completion Date April 4, 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02031302
Other Study ID Numbers TP6461
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
Responsible Party Boston Scientific Corporation
Study Sponsor Boston Scientific Corporation
Collaborators Not Provided
Investigators
Principal Investigator: Nicolas Van Mieghem, MD Erasmus Medical Center
Principal Investigator: Volkmar Falk, MD, PhD German Heart Center Berlin
PRS Account Boston Scientific Corporation
Verification Date March 2019