Mortality Post-TAVI and Correlation With Haemodynamic Parameters.

Aortic Valve Stenosis Clinical Trial

Official title:

Mortality Post-TAVI and Correlation With Haemodynamic Parameters.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769545
• Other study ID #: 258843
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: December 31, 2017

Study information

• Verified date: December 2018
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Until a few years ago the only interventional option available for severe aortic stenosis was surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was applied for the first time in humans, the transcatheter aortic valve implantation (TAVI). Initially this procedure was reserved for those patients deemed too high risk for surgical intervention. As technology progressed in this domain, the indication for TAVI expanded to a broader population of patient with severe aortic stenosis. To-date there are no long-term data for mortality and this is the central question this study will explore in correlation with haemodynamic parameters. Essentially, this study will explore the effect of TAVI in the long term. All patients that had a TAVI within the RBH&HH NHS Foundation Trust between January 2008 and December 2017 will be included in the study. This is a retrospective study.

Description:

Aortic valve stenosis is the most prevalent valvulopathy in the developed world countries. Until a few years ago the only interventional option available for severe aortic stenosis was surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was applied for the first time in humans, the transcatheter aortic valve implantation (TAVI) as a keyhole procedure. Initially this procedure was reserved for those patients deemed too high risk for surgical intervention. As technology progressed in this domain, the indication for TAVI expanded to a broader population of patient with severe aortic stenosis. As the experience broadens there are no long-term data for mortality and this is the central question this study will explore in correlation with haemodynamic parameters. Essentially, this study will explore the effect of TAVI in the long term. All patients that had a TAVI within the RBH&HH NHS Foundation Trust between January 2008 and December 2017 will be included in the study. This is a retrospective study and will not change anything in the patients' standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with TAVI within the Royal Brompton & Harefield NHS Foundation Trust

Exclusion Criteria:

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

References & Publications (3)

Adams HS, Ashokkumar S, Newcomb A, MacIsaac AI, Whitbourn RJ, Palmer S. A Contemporary Review of Severe Aortic Stenosis. Intern Med J. 2018 Aug 8. doi: 10.1111/imj.14071. [Epub ahead of print] Review. — View Citation

Cocchieri R, Petzina R, Romano M, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Bapat V, Baumbach H, Sims H, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Frank D. Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE. Eur J Cardiothorac Surg. 2018 Oct 20. doi: 10.1093/ejcts/ezy333. [Epub ahead of print] — View Citation

Denegri A, Mehran R, Holy E, Taramasso M, Pasotti E, Pedrazzini G, Moccetti T, Maisano F, Nietlispach F, Obeid S. Post procedural risk assessment in patients undergoing trans aortic valve implantation according to the age, creatinine, and ejection fraction-7 score: Advantages of age, creatinine, and ejection fraction-7 in stratification of post-procedural outcome. Catheter Cardiovasc Interv. 2018 Sep 30:e27806. doi: 10.1002/ccd.27806. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death post-TAVI	Death during or after TAVI	Within 3 years from TAVI procedure