NCT04047082

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 24, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

June 24, 2019

Last Update Submit

August 6, 2019

Conditions

Aortic Valve InsufficiencyHeart Valve DiseasesRegurgitation, AorticParavalvular Aortic Regurgitation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Comparison of online feasibility with core lab feasibility

    immediately

Interventions

Quantitative aortogram (videodensitometry)DIAGNOSTIC_TEST

Patients that performed TAVR will have their aortogram analysed in the cath-lab by videodensitometry (quantitative aortogram)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe symptomatic aortic stenosis, requiring valve replacement.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Center

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33582086DERIVED

MeSH Terms

Conditions

Aortic Valve InsufficiencyHeart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular Diseases

Study Officials

  • Patrick W Serruys, MD, PhD

    Imperial College London

    STUDY CHAIR

  • Rodrigo Modolo, MD, PhD

    Amsterdam University Medical Center

    PRINCIPAL INVESTIGATOR

  • Robbert de Winter, MD, PhD

    Amsterdam University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick W Serruys, MD, PhD

CONTACT

+31102062828patrick.w.j.c.serruys@gmail.com

Yoshinobu Onuma, MD, PhD

CONTACT

+31102062828yoshinobuonuma@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2019

First Posted

August 6, 2019

Study Start

May 15, 2019

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Locations

NL(1)