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| 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.
|
| 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.
|
| 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.
|
| 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.
|
| 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
|
| 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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