Edwards Sapien 3 Ultra delivery system used with S3 and S3 Ultra THV.

• Research type

  Research Study

• Full title

  A Prospective, Single-arm, Multi-centre Study of the SAPIEN 3 Ultra Delivery System used with the SAPIEN 3 Ultra THV and SAPIEN 3 THV in Intermediate Risk Patients with Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

• IRAS ID

  244949

• Contact name

  Stepanka Strnadova

• Contact email

  Stepanka_Strnadova@edwards.com

• Sponsor organisation

  Edwards Lifesciences LLC

• Clinicaltrials.gov Identifier

  NCT03471065

• Duration of Study in the UK

  5 years, 3 months, 31 days

• Research summary

  Research Summary

  Aortic Stenosis is one of the commonest forms of valvular disease in developed countries, and left un-treated leads to debilitation and can be life threating. Aortic valve replacement is the gold standard treatment for this disease in subjects who do not have a high procedural risk and outcomes after surgical AVR (SAVR) are excellent in those patients. Transcatheter aortic valve replacement (TAVR) was developed for subjects deemed to be at high risk during surgery and numerous studies have compared TAVR to SAVR and in this high risk category, TAVR has been found to be superior to SAVR.
  This study will evaluate the procedural safety and performance of the SAPIEN 3 Ultra Delivery System and Axela Sheath with the SAPIEN 3 Ultra Transcatheter Heart Valve (THV) (20, 23 and 26 mm sizes) and SAPIEN 3 THV System (29 mm size). The SAPIEN 3 Ultra THV design differs from the SAPIEN 3 design only with respect to the weave of the outer skirt and attachment of the skirt to the frame. The SAPIEN 3 Ultra Delivery System allows the THV to be crimped directly onto the deployment balloon eliminating the need for valve alignment and reducing the number of procedural steps. The Axela Sheath has a reduced profile of 14 French across all valve sizes.
  The study will be conducted at 4 sites across Canada and the UK and involve 20 subjects having the implant. Each subjects will be followed up after 30 days, 6 months and yearly to 5 years to determine the safety and performance of the device. These being measured in terms of mortality, the need for surgery and valve regurgitation, as well as other vascular problems

  Summary of Results

  The Edwards SAPIEN 3 Ultra is a heart valve used to treat people who have a serious narrowing of their aortic valve. These patients were at intermediate risk for open-heart surgery. The treatment was shown to be safe and worked well for most people. Most patients got through the procedure safely, didn’t need emergency surgery, had very little leaking around the new valve, and didn’t have serious problems with their blood vessels. The new valve stayed in place and didn’t move.
  Five years after the procedure, about one in three patients passed away, and about one in twenty had a stroke. Only a small number needed another valve procedure, and a small number of patients developed infections or blood clots in the valve.
  Most people felt better after the procedure. Five years later, 6 out of 10 patients had fewer symptoms, and nearly 9 out of 10 had only mild or no symptoms at all. The valve started working better within the first month, and only about 1 in 100 patients had noticeable leaking around the valve at that time.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  18/LO/0558

• Date of REC Opinion

  24 Apr 2018

• REC opinion

  Favourable Opinion