Portico TAVI Implant With Transfemoral Delivery System

NCT01493284 | Completed Results DMC

• 1 other identifier: 1105
• Study Type: interventional
• Target: 222
• Locations: 5 countries
• Sites: 14

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).

Conditions

Symptomatic Aortic Stenosis

Keywords

aortic stenosis; aortic valve stenosis; valvular heart disease; aortic valve replacement; transcatheter aortic valve implantation; TAVI

Outcome Measures

Primary Outcomes (1)

• All Cause Mortality

  Number of participants that reported all cause mortality

  30 days

Secondary Outcomes (3)

• Number of Select Cardiovascular Adverse Events

  30 days

• Participant NYHA Classification at Day 30

  day 30

• Number of Participants With Acute Device Success

  7 days

Study Arms (1)

Transfemoral Access

EXPERIMENTAL

Transfemoral Access for transcatheter aortic valve implant

Device: Transcatheter Aortic Valve Implantation

Interventions

Transcatheter Aortic Valve Implantation DEVICE

Placement of the SJM Portico aortic valve with a transfemoral delivery system

Transfemoral Access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has given written study Informed Consent for participation prior to procedure.
• 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 echocardiogram (echo) or CT conducted within the past 90 days.
• Subject has senile degenerative aortic stenosis with echocardiography (echo) derived mean gradient \>40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of \<1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2). (Baseline measurement taken by echo within 30 days of procedure).
• Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
• Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee (See Section 3.1 for the definition of the Subject Selection Committee)
• Subject's predicted operative mortality or serious, irreversible morbidity risk is \<50% at 30 days.
• In the opinion of the Subject Selection Committee and based upon angiographic measurements, the subject has suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.
• Subject has structurally normal cardiac anatomy.
• Subject is willing and able to comply with all required follow-up evaluations.

You may not qualify if:

• Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of the index procedure.
• Subject has carotid artery disease requiring intervention.
• Subject has evidence of a myocardial infarction (MI) within the past 6 months (≤180 days) of the index procedure.
• Subject has hypertrophic cardiomyopathy.
• Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
• Subject has mitral or tricuspid valvular regurgitation (\>grade III) or moderate to severe mitral stenosis.
• Subject has aortic root angulation \>70 degrees (horizontal aorta).
• Subject has a pre-existing prosthetic valve or prosthetic ring in any position.
• Subject refuses blood transfusion or surgical valve replacement.
• Subject has left ventricular ejection fraction (LVEF) \< 20%.
• The subject has documented, untreated coronary artery disease (CAD) requiring revascularization.
• Subject has severe basal septal hypertrophy.
• Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days of the index procedure.
• Subject has a history of or has active endocarditis.
• Subject has echocardiographic evidence of intracardiac mass, thrombus, or vegetation.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (14)

Adelaide Royal Hospital

Adelaide, Australia

Location

Rigshospitalet Copenhagen

Copenhagen, Denmark

Location

Kerckhoff Klinik

Bad Nauheim, Germany

Location

Heart Center Bernau

Bernau, Germany

Location

Asklepios Klinik-St. Georg

Hamburg, Germany

Location

Klinikum der Universität Jena

Jena, Germany

Location

Klinik fur Herzhirurgie Karlruhe GmbH

Karlsruhe, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

Medical Center Leeuwarden

Leeuwarden, Netherlands

Location

Royal Victoria Hospital

Belfast, Northern Ireland, BT12 6BA, United Kingdom

Location

Glenfield Hospital

Leicester, United Kingdom

Location

Kings College

London, United Kingdom

Location

St. Thomas' Hospital

London, United Kingdom

Location

Derriford Hospital, Plymouth

Plymouth, United Kingdom

Location

Related Publications (2)

• Walther T, Manoharan G, Linke A, Mollmann H, Holzhey D, Worthley SG, Kim WK, Schafer U. Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico valve. Eur J Cardiothorac Surg. 2018 Sep 1;54(3):467-474. doi: 10.1093/ejcts/ezy078.

  PMID: 29534170 DERIVED

• Linke A, Holzhey D, Mollmann H, Manoharan G, Schafer U, Frerker C, Worthley SG, van Boven AJ, Redwood S, Kovac J, Butter C, Sondergaard L, Lauten A, Schymik G, Walther T. Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study. Circ Cardiovasc Interv. 2018 Feb;11(2):e005206. doi: 10.1161/CIRCINTERVENTIONS.117.005206.

  PMID: 29444998 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Results Point of Contact

• Title: Sr Clinical Scientist
• Organization: St Jude Medical

alicia.kimber@abbott.com

4159179696

Study Officials

• Ganesh Manoharan, MD

  Royal Victoria Hospital, Belfast

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 15, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: September 1, 2016
• Last Updated: February 4, 2019
• Results First Posted: April 23, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NL (1); DE (6); DK (1); GB (5)