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Trial record 3 of 140 for:    OVAL

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
Sponsor:
Collaborator:
Amsterdam University Medical Center
Information provided by (Responsible Party):
Patrick W. Serruys, Imperial College London

Brief 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)

Condition or disease Intervention/treatment
Aortic Valve Insufficiency Heart Valve Diseases Regurgitation, Aortic Paravalvular Aortic Regurgitation Diagnostic Test: Quantitative aortogram (videodensitometry)

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

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


Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe symptomatic aortic stenosis, requiring valve replacement.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Patrick W Serruys, MD, PhD +31102062828 patrick.w.j.c.serruys@gmail.com
Contact: Yoshinobu Onuma, MD, PhD +31102062828 yoshinobuonuma@gmail.com

Locations
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Netherlands
Amsterdam University Medical Center Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Patrick W Serruys, Prof. dr.    +31102062828    patrick.w.j.c.serruys@gmail.com   
Sponsors and Collaborators
Imperial College London
Amsterdam University Medical Center
Investigators
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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
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Responsible Party: Patrick W. Serruys, Professor, Imperial College London
ClinicalTrials.gov Identifier: NCT04047082    
Other Study ID Numbers: OVAL
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Valve Diseases
Aortic Valve Insufficiency
Heart Diseases
Cardiovascular Diseases