Self-Centering Guide Catheter Feasibility Study
27 augusti 2018 uppdaterad av: Boston Scientific Corporation
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide Catheter.
All subjects who are candidates for transcatheter aortic valve replacement (TAVR) of a native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques will be evaluated for enrollment in this study.
The Self-Centering Guide Catheter is intended to facilitate delivery of a guidewire across a stenotic native aortic valve and into the left ventricle.
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Minnesota
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 110 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Subject must be at least 18 years of age.
- Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Subject is eligible for and is an acceptable candidate for transcatheter aortic valve replacement of a stenotic (aortic valve area ≤1 cm2, aortic jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg) native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques.
Exclusion Criteria:
- Subject has known hypersensitivity to the components of the device (e.g., polyether block amide, fluoropolymers, nickel, platinum, tantalum, titanium).
- Subject has a pre-existing prosthetic aortic valve.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Enhetens genomförbarhet
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Self-Centering Guide Catheter
Subjects who provided written informed consent and an attempt is made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle
Tidsram: Through study completion, up to 72 hours post-procedure
|
This outcome will be assessed via physician determination and will be recorded in the case report form.
|
Through study completion, up to 72 hours post-procedure
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve
Tidsram: Through study completion, up to 72 hours post-procedure
|
Through study completion, up to 72 hours post-procedure
|
|
|
Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body
Tidsram: Through study completion, up to 72 hours post-procedure
|
Through study completion, up to 72 hours post-procedure
|
|
|
Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire
Tidsram: Through study completion, up to 72 hours post-procedure
|
Through study completion, up to 72 hours post-procedure
|
|
|
Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System
Tidsram: Through study completion, up to 72 hours post-procedure
|
The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form.
|
Through study completion, up to 72 hours post-procedure
|
|
Number of Self-Centering Guide Catheters With Device Success
Tidsram: Through study completion, up to 72 hours post-procedure
|
Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system.
This outcome will be assessed via physician determination and will be recorded in the case report form.
|
Through study completion, up to 72 hours post-procedure
|
|
Number of Participants With Stroke
Tidsram: 72 hours post-procedure
|
72 hours post-procedure
|
|
|
Number of Participants With Cardiac Tamponade
Tidsram: 72 hours post-procedure
|
72 hours post-procedure
|
|
|
Death, All-cause, Cardiovascular, and Non-cardiovascular
Tidsram: 72 hours post-procedure
|
72 hours post-procedure
|
|
|
Any Device-related Adverse Event
Tidsram: 72 hours post-procedure
|
72 hours post-procedure
|
|
|
Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject
Tidsram: 72 hours post-procedure
|
72 hours post-procedure
|
|
|
Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors
Tidsram: 72 hours post-procedure
|
All device deficiencies including but not limited to failures, malfunctions, use errors, product nonconformities, and labeling errors will be recorded in the case report form
|
72 hours post-procedure
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Rajiv Gulati, MD, PhD, Mayo Clinic
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 maj 2016
Primärt slutförande (Faktisk)
6 oktober 2016
Avslutad studie (Faktisk)
6 oktober 2016
Studieregistreringsdatum
Först inskickad
17 december 2015
Först inskickad som uppfyllde QC-kriterierna
21 december 2015
Första postat (Uppskatta)
24 december 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 augusti 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 augusti 2018
Senast verifierad
1 augusti 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- S2360
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .