At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- VAVGJ (device), CAVGJ (device)
- How long the study runs
- Study runs about 98 months (dates as stated)
- About the drug or intervention
- VAVGJ — device: Replacement of the aortic valve and ascending aorta · CAVGJ — device: Replacement of the aortic valve and ascending aorta
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is for people having heart surgery to replace an aortic valve using a special graft (a tube-like device that includes a valve, known as a valved graft). It is sponsored by Abbott Medical Devices. It covers conditions affecting the aortic valve, the first part of the body's main artery (the ascending aorta), and aortic dissection (a tear in the wall of the main artery).
Who can take part
- People having heart surgery that includes implanting a type of valved graft (called a VAVGJ or CAVGJ) to replace their own or a previously fitted heart valve
Who may not be able to
- People who cannot tolerate blood-thinning medicine (anticoagulation therapy)
- People with an active infection of the heart's inner lining (endocarditis)
- People with any physical, medical, surgical, mental or social reasons that would make taking part unsuitable
What taking part involves
- • Heart surgery to implant a valved graft to replace the aortic valve
- • The exact study procedures after surgery are not stated in the registry data — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 260
- Started
- 2021-07-13
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for aortic valve disease
- • Clinical study - 260 participants
- • Multicenter, global, prospective, non-randomized, interventional, post-market trial
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with aortic valve disease
Where?
- • Middlesbrough - James Cook University Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓heart surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement
Who cannot take part
- ✗anticoagulation therapy intolerant
- ✗active endocarditis
- ✗anatomical or medical, surgical, psychological or social contraindications
See the full criteria
Where Is This Study? (1 UK site)
James Cook University Hospital
Middlesbrough TS43BW, United Kingdom
How to Get in Touch
Paolo Amato
Sponsor contactCONTACT
Karine Miquel
Sponsor contactCONTACT