KONECT RESILIA Aortic Valved Conduit real-world use in adults needing valve and ascending aorta replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational, multicenter study enrolling up to 250 participants across Europe and Canada who will receive the KONECT RESILIA AVC (Model 11060A) during surgery. It collects real-world clinical outcomes after the device is implanted as part of aortic valve replacement and repair/replacement of the ascending aorta, without a randomized comparison. Participants are followed according to a protocol at up to 20 sites to assess safety and performance in routine clinical practice. Eligible patients are adults with diseased native or prosthetic valves and a diseased ascending aorta requiring conduit replacement, with specific exclusion criteria to ensure appropriate risk and safety monitoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years or older at the time of informed consent
2. 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
3. Provide written informed consent
4. Willing to follow protocol requirements

Exclusion Criteria:

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

Where it's running

• TUM Klinikum Deutsches Herzzentrum
  München, Bavaria, Germany Recruiting
• Universitätsklinikum Bonn
  Bonn, North Rhine-Westphalia, Germany Recruiting
• Deutsches Herzzentrum der Charité
  Berlin, Germany Recruiting

Study contacts

• Principal investigator: Markus Krane, Prof. Dr. med. — TUM Universitätsklinikum Deutsches Herzzentrum
• Study coordinator: Sabrina Hundt, PhD
• Email: Sabrina_Hundt@edwards.com
• Phone: +49 (0)151 67550601

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Savvywire versus standard LV guidewires during transfemoral TAVI

  For people 50 and older having transfemoral TAVI, researchers will compare the Savvywire and standard LV guidewires to see if the Savvywire improves pacing and procedure-related blood flow.

  Recruiting Catharina Ziekenhuis Eindhoven · Eindhoven, North Brabant · NCT07366671

• EmStop Embolic Protection System for TAVR in Aortic Valve Stenosis

  This study tests whether the EmStop protective device can safely capture and remove debris during transcatheter aortic valve replacement in adults with severe aortic valve stenosis.

  Recruiting at 7 sites EmStop Inc · Thousand Oaks, California and 6 other locations · NCT07276711

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

• Real-world outcomes of the INSPIRIS RESILIA aortic valve in adults

  This registry will collect real-world data to see how the INSPIRIS RESILIA aortic valve performs in adults undergoing aortic valve replacement.

  Recruiting at 15 sites Edwards Lifesciences · Heidelberg, Baden-Wurttemberg and 14 other locations · NCT07120048

• Transcatheter JenaValve or J-Valve treatment for severe aortic regurgitation

  This project will try two transcatheter heart valves (JenaValve and J-Valve) to treat people with severe symptomatic aortic regurgitation who are high risk for open-heart surgery.

  Recruiting Prince of Wales Hospital, Shatin, Hong Kong · Hong Kong, Shatin · NCT07021612

• CardioHeartConnect: Home Peloton cardiac rehab after TAVR

  This trial tests whether an eight-week home-based Peloton program paired with a smartwatch helps people recovering from TAVR become more active and improve heart-related health compared with educational materials.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT07008911

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.