Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab (OVAL)
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|ClinicalTrials.gov Identifier: NCT04047082|
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : August 8, 2019
|Condition or disease||Intervention/treatment|
|Aortic Valve Insufficiency Heart Valve Diseases Regurgitation, Aortic Paravalvular Aortic Regurgitation||Diagnostic Test: Quantitative aortogram (videodensitometry)|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
- Diagnostic Test: Quantitative aortogram (videodensitometry)
Patients that performed TAVR will have their aortogram analysed in the cath-lab by videodensitometry (quantitative aortogram)
- Feasibility of analysis(percentage of cases considered analyzable by videodensitometry - online) [ Time Frame: immediately ]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).
- 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%) [ Time Frame: immediately ]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).
- Comparison of online feasibility with core lab feasibility [ Time Frame: immediately ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047082
|Contact: Patrick W Serruys, MD, PhDfirstname.lastname@example.org|
|Contact: Yoshinobu Onuma, MD, PhDemail@example.com|
|Amsterdam University Medical Center||Recruiting|
|Amsterdam, Netherlands, 1105 AZ|
|Contact: Patrick W Serruys, Prof. dr. +31102062828 firstname.lastname@example.org|
|Study Chair:||Patrick W Serruys, MD, PhD||Imperial College London|
|Principal Investigator:||Rodrigo Modolo, MD, PhD||Amsterdam University Medical Center|
|Principal Investigator:||Robbert de Winter, MD, PhD||Amsterdam University Medical Center|