Mortality Post-TAVI and Correlation With Haemodynamic Parameters.

NCT03769545 | Completed

• 1 other identifier: 258843
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Death post-TAVI

  Death during or after TAVI

  Within 3 years from TAVI procedure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Related Publications (3)

• 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. 2019 Jan 1;93(1):141-148. doi: 10.1002/ccd.27806. Epub 2018 Sep 30.

  PMID: 30269398 BACKGROUND

• 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 ROUTEdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):737-743. doi: 10.1093/ejcts/ezy333.

  PMID: 30346515 BACKGROUND

• Adams HSL, Ashokkumar S, Newcomb A, MacIsaac AI, Whitbourn RJ, Palmer S. Contemporary review of severe aortic stenosis. Intern Med J. 2019 Mar;49(3):297-305. doi: 10.1111/imj.14071.

  PMID: 30091235 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Thomas Luescher

  Director of Research Education and Development, Cardiology (RBH)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow in Interventional Cardiology

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: January 1, 2008
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share