5 Year Observation of Patients With PORTICO Valves

NCT01802788 | Completed Results DMC

• 1 other identifier: CV-12-054-EU-PV
• Study Type: observational
• Target: 1,032
• Locations: 13 countries
• Sites: 60

Brief Summary

The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.

Conditions

Aortic Valve Stenosis

Keywords

Aortic Stenosis; CV-12-054-EU-PV; Heart Valve Prosthesis; Trans Catheter Aortic Valve Replacement; TAVR; Trans Catheter Aortic Valve Implant; TAVI

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With All-cause Mortality

  Percentage of participants that died for any reason at 1 year post implantation

  1 year post implant

Secondary Outcomes (49)

• Percentage of Participants With All Cause Mortality in Cohort A

  30 days through 5 years post implant

• Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B

  30 days through 5 years post implant

• Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A

  30 days through 5 years post implant

• Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B

  30 days through 5 years post implant

• Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A

  30 days through 5 years post implant

Study Arms (2)

Cohort A

Patients implanted with a Portico valve after CE mark

Device: St Jude Medical Portico replacement aortic valve; Procedure: Transcatheter Aortic Valve Implant

Cohort B

Patients implanted in previous SJM-sponsored premarket studies

Device: St Jude Medical Portico replacement aortic valve; Procedure: Transcatheter Aortic Valve Implant

Interventions

St Jude Medical Portico replacement aortic valve DEVICE

Cohort A; Cohort B

Transcatheter Aortic Valve Implant PROCEDURE

Also known as: TAVI, Transcatheter Aortic Valve Replacement, TAVR

Cohort A; Cohort B

Eligibility Criteria

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

Study Population

The study population comprises of Cohort A and Cohort B with severe symptomatic aortic stenosis (AS). Cohort A: Patients enrolled directly into the Portico I study. Cohort B: Patients implanted in previous SJM-sponsored regulatory (pre-market) investigations and first-in-human trials whom consent for ongoing follow-up in the Portico I study after the completion of their participation in the initial study.

You may qualify if:

• Patient has signed the Patient Informed Consent prior to participating in the clinical investigation.
• Patient has been referred for a Portico Valve implant as per Heart Team decision or patient has received a Portico Valve as per participation in an SJM sponsored regulatory or first-in-human trial.
• Patient has senile degenerative aortic valve stenosis confirmed by echocardiographically derived criteria\*:
• An initial aortic valve area (AVA) of less than or equal to (≤) 1.0 cm2 (or indexed EOA less than or equal to (≤) 0.6 cm2/m2) AND
• A mean gradient greater than (\>)40 mmHg or jet velocity greater than (\>)4.0 m/s or Doppler Velocity Index less than (\<)0.25. If the mean gradient is \<40 mmHg and left ventricular ejection fraction (LVEF) \<55%, then the site may as well perform a dobutamine stress echo to see if the mean gradient increases to \>40 mmHg." (Baseline measurement taken by echo within 6 months of index procedure.)
• Patient has a life expectancy more than (\>) 12 months.
• For patients enrolled in a French site:
• Patient is at high risk for surgery as demonstrated by a Logistic EuroSCORE equal or more than (≥) 20 and/or a Society of Thoracic Surgeon (STS) mortality risk score of more than (\>) 10% and/or by clinical judgment of the Heart Team based on the individual risk profile (comorbidities).
• Not applicable for a patient who has received a Portico Valve as per participation in an SJM sponsored Regulatory or First-In-Human trial.

You may not qualify if:

• Any case in which the Portico Valve would not be indicated for the patient as per current instructions for use (i.e any "off-label" use).
• Patient has any other aortic valve than tricuspid one.
• Patient has a prosthetic valve or ring in the aortic position.
• Patient needs a concomitant structural heart procedure..
• Patient needs the usage of an embolic protection device.
• Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations.
• Patient is pregnant

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (60)

Royal Adelaide Hospital

Adelaide, Australia

Location

St Andrews Hospital

Adelaide, Australia

Location

Heart Care Partners-Wesley Hospital

Auchenflower, Australia

Location

The Prince Charles Hospital

Chermside, Australia

Location

Royal North Shore hospital

Leonards Hill, Australia

Location

The Alfred Hospital

Melbourne, Australia

Location

Royal Melbourne Hospital - City Campus

Parkville, Australia

Location

Fiona Stanley Hospital

Perth, Australia

Location

North Shore Private Hospital

St Leonards, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Australia

Location

AZ Middelheim

Antwerp, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

CHR Citadelle

Liège, Belgium

Location

Foothills Medical Centre

Calgary, Canada

Location

Queen Elizabeth II Heath Sciences

Halifax, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Canada

Location

Ottawa Heart Institute

Ottawa, Canada

Location

Institut de Cardiologie de Quebec (Hospital Laval)

Québec, Canada

Location

Saint John Regional Hospital - New Brunswick Heart Centre

Saint John, Canada

Location

Toronto General Hospital

Toronto, Canada

Location

St. Paul's Hospital

Vancouver, Canada

Location

Rigshospitalet

Copenhagen, Denmark

Location

CHRU Hopital de Pontchaillou

Rennes, France

Location

CHU Rangueil Toulouse

Toulouse, France

Location

Clinique Pasteur Toulouse

Toulouse, France

Location

Kerckhoff-Klinik gGmbH

Bad Nauheim, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, Germany

Location

Immanuelklinikum Bernau und Herzzentrum Brandenburg

Bernau, Germany

Location

St Johannes Hospital

Dortmund, Germany

Location

Herzzentrum Dresden GmbH Universitatsklinik

Dresden, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitat Frankfurt

Frankfurt, Germany

Location

Universitatsmedizin Gottingen Georg-August-Universitat

Göttingen, Germany

Location

Asklepios Klinikum St Georg

Hamburg, Germany

Location

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, Germany

Location

Universitatsklinikum Jena

Jena, Germany

Location

Stadtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik I

Karlsruhe, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Deutsches Herzzentrum Munchen des Freistaates Bayern

München, Germany

Location

Kaplan Medical Center

Rehovot, Israel

Location

Clinica Citta di Alessandria

Alessandria, Italy

Location

Azienda Ospedali V. Emanuele Ferrarotto E S. Bambino

Catania, Italy

Location

Fondazione Toscana Gabriele Monasterio - Ospedale del Cuore

Massa, Italy

Location

Istituto Sant'Ambrogio

Milan, Italy

Location

Ospedale Niguarda Ca'Granda

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

PoliclinicoSan Donato

Milan, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Policlinico di Monza

Monza, Italy

Location

Vilnius University Hospital Santarisku KLinikos

Vilnius, Lithuania

Location

OLVG

Amsterdam, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain

Location

Hospital Clinico Universitario Virgen de Arrixaca

El Palmar, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Universitatspital Spital Zurich

Zurich, Switzerland

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

The Royal Sussex Country Hospital

Brighton, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Morriston hospital-ABM University Health Board

Morriston, United Kingdom

Location

Related Publications (2)

• Puri R, Thiele H, Fichtlscherer S, Westermann D, Makkar R, Waksman R, Hakmi S, Sondergaard L, Groh M, Montarello JK, Kempfert J, Yong G, Bedogni F, Maisano F, Worthley SG, Rodes-Cabau J, Fontana GP, Mollmann H. Five-Year Clinical Outcomes and Durability of a Self-Expanding Transcatheter Heart Valve With Intra-Annular Leaflets. Circ Cardiovasc Interv. 2025 Dec;18(12):e015430. doi: 10.1161/CIRCINTERVENTIONS.125.015430. Epub 2025 Oct 24.

  PMID: 41133305 DERIVED

• Sondergaard L, Rodes-Cabau J, Hans-Peter Linke A, Fichtlscherer S, Schafer U, Kuck KH, Kempfert J, Arzamendi D, Bedogni F, Asch FM, Worthley S, Maisano F. Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2859-2867. doi: 10.1016/j.jacc.2018.09.014. Epub 2018 Sep 24.

  PMID: 30261238 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; 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

Limitations and Caveats

Cohort B entered the study after completion of their 1 year follow-up in other trials, therefore there are no results for Cohort B prior to 2 years collected in this study.

Results Point of Contact

• Title: Vinny Podichetty, Clinical Program Director
• Organization: Abbott

vinny.podichetty@abbott.com

779-209-9425

Study Officials

• Francesco Maisano, MD

  San Raffaele Hospital

  PRINCIPAL INVESTIGATOR

• Stephen Worthley

  St Andrews Hospital

  PRINCIPAL INVESTIGATOR

• Josep Rodes-Cabau

  Institut de Cardiologie de Quebec (Hospital Laval)

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: March 1, 2013
• Study Start: April 16, 2013
• Primary Completion: September 25, 2018
• Study Completion: October 19, 2022
• Last Updated: February 11, 2025
• Results First Posted: January 24, 2022

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); CA (8); IL (1); DK (1); FR (3); IT (9); CH (1); DE (14); AU (10); LI (1); NL (2); GB (4); ES (3)