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CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.

NCT03752866 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1001

Last updated 2024-10-21

Study results available
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Summary

The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.

Conditions

  • Symptomatic Degenerative Aortic Stenosis
  • Severe Aortic Stenosis

Interventions

DEVICE

Portico™ Valve, Portico Delivery System(s) and Loading System(s)

Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.

DEVICE

Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)

Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Helge Möllmann · St. Johannes Hospital, Dortmund, Germany

  • Vinny Podichetty · Abbott Structural Heart

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2021-11-02
Completion
2022-07-28

Countries

  • Australia
  • Belgium
  • Czechia
  • Germany
  • Italy
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03752866 on ClinicalTrials.gov