START YOUNG

• Research type

  Research Study

• Full title

  Surgical Bioprosthesis Aortic Valve Replacement Vs. Myval Balloon-Expandable THV Series in Patients Aged 65 to 75 with Symptomatic Severe Aortic Stenosis

• IRAS ID

  359241

• Contact name

  David HILDICK-SMITH

• Contact email

  david.hildick-smith@nhs.net

• Sponsor organisation

  Center for European Research Initiatives in Cardiovascular Medicine (CERIC)

• Clinicaltrials.gov Identifier

  NCT06861361

• Duration of Study in the UK

  7 years, 0 months, 30 days

• Research summary

  Degenerative aortic valve stenosis (AS) is one of the most common acquired valvular diseases in adults over 65 years. Prevalence of AS is continuously growing as the average age of the population increases. Once symptoms occur, the prognosis is very poor; the mean survival in patients with severe, untreated symptomatic aortic stenosis is approximately 2-3 years. Medical therapy can only delay, but not reverse or stop the progress of AS.

  Currently, the recommendations propose a surgical operation (SAVR) to replace the aortic valve in patients under 75 years. In older or high-risk patients, a less invasive method, called TAVR (catheter replacement), is preferred. Some studies have shown that TAVR gives similar results to SAVR, but its long-term effectiveness in patients aged 65 to 75 remains to be proven.

  START YOUNG is a prospective clinical study, carried out in 60 hospitals in 12 countries worldwide. In each hospital, two departments participate: interventional cardiology for TAVR and surgery for SAVR, each with a doctor in charge.

  The objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.

  Patients are divided by random draw (1:1) between two groups. One will receive TAVR with one of the transcatheter heart valves from the Myval family, commercially available in the UK, while the other will receive a valve implantation by surgery.

  The study will include 1,180 patients with severe aortic stenosis aged 65 to 75 years over a period of 24 months.
  After valve implantation, patients will be followed up for 5 years, with visits at 30 days, 12 months, and then annually. At discharge and then at 1, 3 and 5 years, a heart ultrasound is done to check how well the new valve is working.
  

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  25/LO/0833

• Date of REC Opinion

  16 Jan 2026

• REC opinion

  Further Information Favourable Opinion