Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02031302




Registration number
NCT02031302
Ethics application status
Date submitted
6/01/2014
Date registered
9/01/2014
Date last updated
19/11/2021

Titles & IDs
Public title
RESPOND Post Market Study
Scientific title
RESPOND: Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes
Secondary ID [1] 0 0
TP6461
Universal Trial Number (UTN)
Trial acronym
RESPOND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Lotus Valve System

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.

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.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause Mortality
Timepoint [1] 0 0
30 Days
Primary outcome [2] 0 0
All-cause Mortality
Timepoint [2] 0 0
1 Year
Secondary outcome [1] 0 0
Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke
Timepoint [1] 0 0
30 Days and 1 year
Secondary outcome [2] 0 0
In-hospital Mortality
Timepoint [2] 0 0
Duration of hospital stay, an expected average of 2 days
Secondary outcome [3] 0 0
Percentage of Participants With Events Included in the VARC Efficacy Composite Endpoint
Timepoint [3] 0 0
1 Year
Secondary outcome [4] 0 0
Patients With Valve Safety Composite Outcomes at 1 Year
Timepoint [4] 0 0
1 Year
Secondary outcome [5] 0 0
Patients With VARC Safety Composite Outcomes at 30 Days
Timepoint [5] 0 0
30 Days
Secondary outcome [6] 0 0
Patients With Moderate and Severe Paravalvular Aortic Valve Regurgitation
Timepoint [6] 0 0
Duration of hospital stay, an expected average of 2 days

Eligibility
Key inclusion 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/05/2021
Sample size
Target
Accrual to date
Final
1064
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Cali
Country [2] 0 0
Colombia
State/province [2] 0 0
Floridablanca
Country [3] 0 0
Finland
State/province [3] 0 0
Helsinki
Country [4] 0 0
Finland
State/province [4] 0 0
Turku
Country [5] 0 0
Germany
State/province [5] 0 0
NRW
Country [6] 0 0
Germany
State/province [6] 0 0
Rheinland Pfalz
Country [7] 0 0
Germany
State/province [7] 0 0
Bad Segeberg
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Germany
State/province [9] 0 0
Bonn
Country [10] 0 0
Germany
State/province [10] 0 0
Hamburg
Country [11] 0 0
Germany
State/province [11] 0 0
Leipzig
Country [12] 0 0
Germany
State/province [12] 0 0
Munich
Country [13] 0 0
Germany
State/province [13] 0 0
Rostock
Country [14] 0 0
Germany
State/province [14] 0 0
Siegburg
Country [15] 0 0
Germany
State/province [15] 0 0
Ulm
Country [16] 0 0
Israel
State/province [16] 0 0
Petach Tikva
Country [17] 0 0
Italy
State/province [17] 0 0
Mi
Country [18] 0 0
Italy
State/province [18] 0 0
PD
Country [19] 0 0
Italy
State/province [19] 0 0
PI
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Netherlands
State/province [21] 0 0
EM
Country [22] 0 0
Netherlands
State/province [22] 0 0
Rotterdam
Country [23] 0 0
New Zealand
State/province [23] 0 0
Hamilton
Country [24] 0 0
Norway
State/province [24] 0 0
Bergen
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Poland
State/province [26] 0 0
Warsaw
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Spain
State/province [28] 0 0
San Sebastián
Country [29] 0 0
Sweden
State/province [29] 0 0
Gothenburg
Country [30] 0 0
Switzerland
State/province [30] 0 0
Bern
Country [31] 0 0
United Kingdom
State/province [31] 0 0
England
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Brighton
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Leeds
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Leicester
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02031302
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Nicolas Van Mieghem, MD
Address 0 0
Erasmus Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02031302