VISTA Study: Study on the Clinical Follow-up of Navitor after Market Release
Summary description of the study
This study involves patients with symptomatic severe aortic stenosis at high or very high risk for surgical aortic valve replacement. The patients are considered eligible for implantation of the Navitor heart valve according to the local heart team's assessment. The aim of the proposed clinical study is to collect additional data to assess the safety and efficacy of the Navitor transcatheter aortic valve. The Navitor heart valve is a heart valve replacement that is introduced through an incision in the groin or near the shoulder via a thin tube and placed in the heart, thus avoiding open-heart surgery. All medical devices used are approved in Switzerland for patients at high or very high risk for surgical aortic valve replacement. Patient inclusion is site-dependent in two different cohorts (A or B), and information is collected during standard treatment in the study. In both cohorts, the same examinations are performed, but the observation period is five years in cohort A and one year in cohort B. Approximately 1000 patients will be enrolled in the study at up to 75 sites worldwide. In Switzerland, one center will participate, and it is expected that approximately 20 patients will participate in this center.
(BASEC)
Intervention under investigation
To assess the safety and efficacy of the commercially approved Navitor heart valve, data will be collected from patients before, during, and after standard treatment at the study center from standard medical tests (e.g., echocardiograms). Additionally, patients will complete a quality of life questionnaire for the study.
Data to assess clinical outcomes will be collected in cohort (group) A over a period of approximately 5 years after implantation. In cohort (group) B, data will be collected over a period of one year after implantation.
Patients will have follow-up appointments 30 days and 12 months after implantation of the heart valve. In cohort A, there is an annual appointment up to 5 years after implantation. Quality of life questionnaires will be completed at the study start visit as well as at the visits after 30 days and after one year post-implantation.
Approximately 1000 patients will be enrolled in the study at 75 trial centers worldwide, including about 20 patients in Switzerland. One clinic in Switzerland will participate. The total study duration will be approximately 7 years.
(BASEC)
Disease under investigation
Patients with symptomatic severe aortic stenosis at high or very high risk for surgical aortic valve replacement. The patients are considered eligible for implantation of the Navitor heart valve according to the local heart team's assessment.
(BASEC)
• The patient is scheduled for implantation of the Navitor TAVI system. • The patient has been informed about the nature of the study, agrees to its terms, and has provided a written informed consent that has been approved by the IRB/EC of the respective trial center. • The patient and the treating physician agree that the patient will attend all necessary follow-up appointments after the procedure. (BASEC)
Exclusion criteria
• Life expectancy <12 months from the time of informed consent due to non-cardiac comorbidities. • In the investigator's assessment, the patient has a medical, social, or psychological condition that may limit their ability or willingness to participate in the study or the required tests and/or follow-up appointments within the study, or that may compromise the scientific integrity of the study. • Known contraindication to computed tomography (CT) or sensitivity to contrast agents that cannot be adequately pre-treated. (BASEC)
Trial sites
St. Gallen
(BASEC)
Sponsor
Abbott 5050 Nathan Lane N Plymouth, MN 55442 USA
(BASEC)
Contact
Contact Person Switzerland
Heiko Zerlik
+41 79 457 54 54
heiko.zerlik@clutterabbott.comAbbott Medical (Schweiz) AG
(BASEC)
General Information
Universittsmedizin Rostock, GermanyClinique Pasteur Toulouse, France
+32471723201
heiko.zerlik@clutterabbott.com(ICTRP)
Scientific Information
Clinique Pasteur Toulouse, France
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
07.09.2023
(BASEC)
ICTRP Trial ID
NCT06008080 (ICTRP)
Official title (approved by ethics committee)
VISTA Nova Study: Navitor Post-Market Clinical Follow Up Study (BASEC)
Academic title
VISTA Study (Navitor Post-Market Clinical Follow Up Study) (ICTRP)
Public title
Post-Market Clinical Follow Up Study With Navitor Valve (ICTRP)
Disease under investigation
Aortic Stenosis (ICTRP)
Intervention under investigation
Device: Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System (ICTRP)
Type of trial
Observational (ICTRP)
Trial design
not available
Inclusion/Exclusion criteria
Inclusion Criteria:
- The patient is scheduled to undergo a Navitor TAVI procedure.
- The patient has been informed of the nature of the study, agrees to its provisions,
and has provided written informed consent as approved by the IRB (Investigational
Review Board)/EC (Ethics Committee) of the respective clinical site.
- The patient and the treating physician agree that the subject will return for all
required post procedure follow up visits.
Exclusion Criteria:
- Life expectancy < 12 months from the time of informed consent due to non-cardiac
co-morbid conditions.
- In the judgment of the Investigator, patient presents with a medical, social, or
psychological condition that could limit the ability or willingness to participate
in the study, comply with study required testing and/or follow-up visits or that
could impact scientific integrity of the study.
- Known contraindication for computed tomography (CT) or sensitivity to contrast
media, which cannot be adequately premedicated.
- Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel
and titanium), which cannot be adequately premedicated.
- Currently participating in an investigational drug or device study that may confound
the results of this study (ICTRP)
not available
Primary and secondary end points
All-cause mortality at 30 days post-TAVI procedure;Moderate or greater paravalvular leak at 30 days post-TAVI procedure (ICTRP)
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Alper ner, MDNicolas Dumonteil, MDBart Janssens, bart.janssens@abbott.com, +32471723201, Universittsmedizin Rostock, GermanyClinique Pasteur Toulouse, France (ICTRP)
Secondary trial IDs
ABT-CIP-10476 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06008080 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available