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Recruiting NCT07619872

KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance

— Observational Aortic Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Edwards KONECT RESILIA AVC.
Who it may be relevant to
Registry conditions: Aortic Valve Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.

Detailed description

Subjects in the KONECTION study will be enrolled at up to 20 sites in Europe and Canada. The population will be participants requiring replacement of their diseased native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.

Interventions

  • Device Edwards KONECT RESILIA AVC
    Surgical replacement of the aortic valve and ascending aorta with the Edwards KONECT RESILIA AVC

Primary outcome measures

  • Percentage of participant's freedom from death and/or device related reintervention [Time frame: ≤ 30 days]
Secondary outcome measures (11)
  • Participant's linearized rate of thromboembolism [Time frame: Events occurring ≥ 31 days and up through 5 years post-implant]
  • Participant's linearized rate of valve thrombosis [Time frame: Events occurring ≥ 31 days and up through 5 years post-implant]
  • Participant's linearized rate of major paravalvular leak [Time frame: Events occurring ≥ 31 days and up through 5 years post-implant]
  • Participant's linearized rate of endocarditis [Time frame: Events occurring ≥ 31 days and up through 5 years post-implant]
  • Participant's linearized rate of major hemorrhage [Time frame: Events occurring ≥ 31 days and up through 5 years post-implant]
  • Percentage of participant's with freedom from death and/or device related reintervention [Time frame: 1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up]
  • Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class [Time frame: Baseline, 1 month, 1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up]
  • Participant's average mean gradient measurement over time [Time frame: 1 month, 1-, 3-, and 5- Years follow-up]
  • Participant's average peak gradient measurement over time [Time frame: 1 month, 1-, 3-, and 5- Years follow-up]
  • Participant's average Effective Orifice Area (EOA) measurement over time [Time frame: 1 month, 1-, 3-, and 5- Years follow-up]
  • Participant's average Effective Orifice Area Index (EOAI) measurement over time [Time frame: 1 month, 1-, 3-, and 5- Years follow-up]

Eligibility criteria

Inclusion criteria

  • 18 years or older at the time of informed consent
  • Have a diseased native or prosthetic aortic valve and a damaged or diseased ascending aorta that requires aortic valved conduit replacement surgery with the KONECT RESILIA AVC
  • Provide written informed consent
  • Willing to follow protocol requirements

Exclusion criteria

  • Active endocarditis or endocarditis within 3 months prior to the study index procedure
  • Emergency procedure
  • Stage 4 renal disease (estimated glomerular filtration rate \[eGFR\] <30 excluded) or requiring dialysis
  • Less than 2-year life expectancy due to non-cardiovascular life-threatening disease in the opinion of the study investigator
  • High predicted risk of mortality prior to the procedure: Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥8%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • TUM Klinikum Deutsches Herzzentrum — München

Identifiers

NCT: NCT07619872 · 2025-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗