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

NCT07619872 | Recruiting FDA Device

• 1 other identifier: 2025-02
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Valve Disease

Keywords

Bentall

Outcome Measures

Primary Outcomes (1)

• Percentage of participant's freedom from death and/or device related reintervention

  Participants' freedom from valve-related death or valve- and/or graft-related reintervention. Time to events were estimated by Kaplan-Meier method.

  ≤ 30 days

Secondary Outcomes (11)

• Participant's linearized rate of thromboembolism

  Events occurring ≥ 31 days and up through 5 years post-implant

• Participant's linearized rate of valve thrombosis

  Events occurring ≥ 31 days and up through 5 years post-implant

• Participant's linearized rate of major paravalvular leak

  Events occurring ≥ 31 days and up through 5 years post-implant

• Participant's linearized rate of endocarditis

  Events occurring ≥ 31 days and up through 5 years post-implant

• Participant's linearized rate of major hemorrhage

  Events occurring ≥ 31 days and up through 5 years post-implant

Study Arms (1)

Edwards KONECT RESILIA AVC

Subjects who were treated with the Edwards KONECT RESILIA AVC

Device: Edwards KONECT RESILIA AVC

Interventions

Edwards KONECT RESILIA AVC DEVICE

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

Edwards KONECT RESILIA AVC

Eligibility Criteria

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

Study Population

The target population includes adult candidates who require replacement of their native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (1)

TUM Klinikum Deutsches Herzzentrum

München, Bavaria, 80636, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Markus Krane, Prof. Dr. med.

  TUM Universitätsklinikum Deutsches Herzzentrum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Hundt, PhD

CONTACT

+49 (0)151 67550601; Sabrina_Hundt@edwards.com

Study Design

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

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2039
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)