|
General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P190023 / PAS002 |
Date Original Protocol Accepted |
11/12/2021
|
Date Current Protocol Accepted |
01/13/2023
|
Study Name |
Registry-Based Real World use Surv of the Portico
|
Device Name |
Portico Transcatheter Aortic Valve Implantation System
|
Clinical Trial Number(s) |
NCT02000115
|
General Study Protocol Parameters |
Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
Data Source |
External Registry
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
The primary objective of this Portico PAS is to confirm the long-term safety and effectiveness of the Portico valve for patients undergoing TAVR with the Portico valve and FlexNav delivery system (DS) in a contemporary real-world setting. The study will be a prospective, single-arm, multi-center, observational real-world surveillance study.
|
Study Population |
All patients that have undergone attempted TAVR with Portico valve (23, 25, 27, or 29-mm sizes) using FlexNav Delivery System at a TVT Registry participating site, from the date of PMA approval (September 17, 2021) through September 24, 2023.
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Sample Size |
There is no minimum sample size. The PAS will include all consecutive patients who have a Portico valve with FlexNav Delivery System implant attempt at institutions participating in the STS/ACC TVT Registry within the first 2 years following PAS start date.
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Key Study Endpoints |
This surveillance will monitor the following: (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening/major bleeding, new requirement for dialysis, new pacemaker implant, peri-procedural myocardial infarction, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 30 days and 12 months; (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months; and (4) all-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) annually at 2-5 year post implantation.
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Follow-up Visits and Length of Follow-up |
Successfully implanted patients will be followed through one (1) year via STS/ACC TVT Registry and through five (5) years via CMS claims data linkage. Patients with attempted but unsuccessful implants with the Portico valve will be followed through 30 days post-procedure.
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Interim or Final Data Summary |
Interim Results |
Safety Results • 30-days endpoints: o All-cause mortality = 3.2% o All stroke = 3.0% o Life threatening or major bleeding = 1.1% o New requirement for dialysis = 0.2% o New permanent pacemaker implantation = 17.0% o Peri-procedural myocardial infarction = 0.0% o Reintervention – Aortic valve related = 0.4% o Neurological (TIA / non-stroke) events = 0.2% o Major vascular complications = 1.2% o Minor vascular complications = 3.8% o Kansas City Cardiomyopathy Questionnaire (KCCQ) - 73.6 (49.7 pre-procedure) • 1-year endpoints: o All-cause mortality = 14.2% o All stroke = 5.4% o Life threatening or major bleeding = 5.7% o New requirement for dialysis = 0.9% o New permanent pacemaker implantation = 19.3% o Peri-procedural myocardial infarction = 1.8% o Reintervention – Aortic valve related = 1.1% o Neurological (TIA / non-stroke) events = 2.0% o Major vascular complications = 1.2% o Minor vascular complications = 4.5% o Kansas City Cardiomyopathy Questionnaire (KCCQ) - 81.6 (49.7 pre-procedure)
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Actual Number of Patients Enrolled |
584
|
Actual Number of Sites Enrolled |
29
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Patient Follow-up Rate |
Of the 584 patients who underwent a Portico procedure, 566 patients (96.9%) had a discharge visit completed. Patients alive that have reached the start of the follow-up window: 517/553 patients (93.5%) completed their 30-day visit and 346/511 patients (67.7%) completed their 1-year visit. For 1-year follow-up, of the 584 patients: 69 have died, 4 have not yet reached the start of window, and 165 do not have data available yet.
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