Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab (OVAL)

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)

Study Overview

• Status: Unknown
• Conditions: Heart Valve Diseases; Aortic Valve Insufficiency; Paravalvular Aortic Regurgitation; Regurgitation, Aortic
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Patrick W Serruys, MD, PhD; Phone Number: +31102062828; Email: patrick.w.j.c.serruys@gmail.com
• Study Contact Backup: Name: Yoshinobu Onuma, MD, PhD; Phone Number: +31102062828; Email: yoshinobuonuma@gmail.com

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Amsterdam University Medical Center
    • Contact: Patrick W Serruys, Prof. dr.; Phone Number: +31102062828; Email: patrick.w.j.c.serruys@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe symptomatic aortic stenosis, requiring valve replacement.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Study Chair: Patrick W Serruys, MD, PhD, Imperial College London; Principal Investigator: Rodrigo Modolo, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Principal Investigator: Robbert de Winter, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

General Publications

• Modolo R, van Mourik M, El Bouziani A, Kawashima H, Rosseel L, Abdelghani M, Aben JP, Slots T, Sahyoun C, Baan J, Henriques JPS, Koch KT, Vis M, Soliman O, Onuma Y, Wykrzykowska J, de Winter R, Serruys PW. Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study. JACC Cardiovasc Interv. 2021 Mar 8;14(5):531-538. doi: 10.1016/j.jcin.2020.11.014. Epub 2021 Feb 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Aortic Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: OVAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No