Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab

Heart Valve Diseases Clinical Trial

— OVAL  

Official title:

Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04047082
• Other study ID #: OVAL
• Status: Recruiting
• Start date: May 15, 2019
• Est. completion date: September 2019

Study information

• Verified date: August 2019
• Source: Imperial College London
• Contact: Patrick W Serruys, MD, PhD
• Phone: +31102062828
• Email: patrick.w.j.c.serruys[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Following the high feasibility of analyses by core laboratory with videodensitometry determined in the ASSESS-REGURGE Registry, this is an early clinical feasibility study of online videodensitometric assessment of aortograms to quantitate aortic regurgitation (AR) in the cath lab, specifically in the setting of transcatheter aortic valve replacement (TAVR)

Description:

OVAL (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab) is a single centre, prospective, proof-of-principle, feasibility study performed in the Academic Medical Centre (Amsterdam). One hundred consecutive patients with aortic stenosis and indication to undergo TAVR by the Institution's Heart team are being enrolled in OVAL. All final aortograms will be performed according to predetermined acquisition protocol and analysed immediately after the acquisition in the cath-lab. All aortograms will also be analysed off-line by an independent core laboratory in the Netherlands (Cardialysis, Rotterdam, The Netherlands).

The primary endpoint of the study is the feasibility of the on-line assessment of regurgitation (percentage of analysable cases). The secondary endpoint is the reproducibility of results between the on-line assessment and the off-line analysis by the independent core laboratory.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive patients with indication to undergo TAVR by the Institution's Heart Team.

Exclusion Criteria:

• Patients that were not considered by the Institution's heart team as eligible

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Heart Valve Diseases
• Paravalvular Aortic Regurgitation
• Regurgitation, Aortic
• Vomiting

Intervention

Diagnostic Test:
• Quantitative aortogram (videodensitometry)
Patients that performed TAVR will have their aortogram analysed in the cath-lab by videodensitometry (quantitative aortogram)

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Amsterdam University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of analysis(percentage of cases considered analyzable by videodensitometry - online)	Feasibility of analysis (percentage of cases considered analyzable by videodensitometry - online). The investigators will assess the percentage of cases that are considered by the investigators as analyzable (i.e., that the investigators are able to perform an on-line analysis of videodensitometry).	immediately
Primary	Comparison with feasibility of ASSESS-REGURGE ( to compare the percentage of analyzable cases with the percentage of the current standard found in ASSESS-REGURGE - 95.5%)	Since ASSESS-REGURGE has the highest feasibility of analysis with quantitative aortogram, the investigators aim to compare the present feasibility (of OVAL) with the new standard from ASSESS-REGURGE. In other words, the percentage of analyzable cases in the present study will be compared with the percentage of analyzable cases found in ASSESS-REGURGE (95.5% of analyzability).	immediately
Secondary	Comparison of online feasibility with core lab feasibility	The feasibility of analysis (i.e., if a cases is considered to be analyzable by videodensitometry) will be assessed on-line by the investigators and also assessed by an academic core laboratory. The result of the feasibility of analysis (percentage of analyzable cases) will be compared between the investigators assessment (on-line) and also by the core laboratory.	immediately