Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access

NCT03056573 | Completed Results

• 1 other identifier: SJM-CIP-10144
• Study Type: interventional
• Target: 64
• Locations: 5 countries
• Sites: 10

Brief Summary

Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System

Conditions

Aortic Valve Stenosis

Keywords

TAVI; Valvular heart disease; Transcatheter aortic valve implantation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Major Vascular Complications

  Major Vascular complication is defined as * Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudo-aneurysm or * Access site or access-related vascular injury leading to death, life-threatening or major bleeding, visceral ischaemia or neurological impairment or * Distal embolization from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage or * The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment or * Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram or * Surgery for access site-related nerve injury or * Permanent access site-related nerve injury

  30 Days

Secondary Outcomes (19)

• Number of All- Cause Mortality

  30 Days

• Number of All- Cause Mortality

  1 Year

• Cardiovascular Mortality

  30 Days

• Cardiovascular Mortality

  1 year

• Number of Participants With Disabling Stroke

  30 Days

Study Arms (2)

Subclavian/axillary

EXPERIMENTAL

Subclavian/axillary access route

Device: Subclavian /Axillary TAVR implant

Transaortic

EXPERIMENTAL

Transaortic access route

Device: Transaortic TAVR Implant

Interventions

Transaortic TAVR Implant DEVICE

Transaortic TAVR implant

Transaortic

Subclavian /Axillary TAVR implant DEVICE

Subclavian /Axillary TAVR implant

Subclavian/axillary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided written informed consent prior to uploading CT scan to core lab.
• Subject is ≥ 18 years of age or legal age in host country.
• Subject's aortic annulus diameter meets the range indicated in the Instructions for Use as measured by multislice CT conducted within 180 days prior to the index procedure.
• Subject has senile degenerative aortic stenosis seen by echocardiography within 90 days of index procedure as measured by:
• mean gradient \>40 mmHg
• Peak velocity ≥ 4.0 m/s
• Doppler Velocity Index \<0.25
• Aortic valve area (AVA) of ≤ 1.0 cm2 or indexed EOA ≤ 0.6 cm2/m2).
• Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of Class II, or greater or other symptoms of aortic stenosis (e.g. syncope).
• Subject is deemed high operable risk and preferred TAVI delivery route is alternate access (subclavian/axillary or direct aortic) per the medical opinion of the center's heart team and confirmed by SSC.
• High risk is defined as an STS mortality \> 8% or documented heart team agreement ≥ high risk for SAVR due to frailty or co-morbidities

You may not qualify if:

• Subject is unwilling or unable to comply with all study-required follow-up evaluations.
• Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to 180 days) prior to the index procedure.
• Subject has carotid artery disease requiring intervention.
• Subject has evidence of a myocardial infarction (MI) within 30 days prior to patient index procedure.
• Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
• Subject has severe mitral valvular regurgitation.
• Subject has severe mitral stenosis.
• Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
• Subject refuses any blood product transfusion.
• Subject has resting left ventricular ejection fraction (LVEF) less than 20%.
• Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
• Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to 14 days prior to index procedure.
• Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement.
• Subject has a history of, or is currently diagnosed with, endocarditis.
• There is imaging evidence of intracardiac mass, thrombus, or vegetation.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (10)

Rigshospitalet Copenhagen

Copenhagen, Denmark

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Universitatsklinikum Tubingen Medizinische Klinik-Kardio

Tübingen, Germany

Location

Ospedale Niguarda Ca'Granda

Milan, Italy

Location

Policlinico San Donato

San Donato Milanese, Italy

Location

Amsterdam Academic Medical Centre (AMC)

Amsterdam, Netherlands

Location

Medical Center Leeuwarden

Leeuwarden, Netherlands

Location

UMC St Radboud

Nijmegen, Netherlands

Location

Basel University Hospital

Basel, Switzerland

Location

Related Publications (1)

• van Wely M, Bruschi G, Bedogni F, Thiele H, Jeger RV, van der Wulp K, Soendergaard L, Kempfert J, Schlensak C, Linke A. Clinical Outcomes of the Portico Transcatheter Aortic Valve Delivered via Alternative Access: 30-Day and 1-Year Results of the Portico ALT Study. J Invasive Cardiol. 2020 Nov;32(11):405-411. doi: 10.25270/jic/20.00109. Epub 2020 Aug 10.

  PMID: 32771997 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Angelic Roach, Clinical Program Director
• Organization: Abbott

angelic.roach@abbott.com

+16517563379

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Portico TF and ALT Delivery System

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 17, 2017
• Study Start: March 29, 2017
• Primary Completion: December 31, 2018
• Study Completion: July 5, 2019
• Last Updated: February 11, 2025
• Results First Posted: March 17, 2020

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); DE (3); CH (1); NL (3); IT (2)