NCT05070130

Brief Summary

In this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment. Post-TAVR FFR will be taken as the reference for predicting ischemic lesions, and angiography and physiology - FFR and diastolic pressure ratio (dPR) - will be performed immediately before and after TAVR, in an all-comer multicentric observational study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

September 2, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

September 19, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

September 2, 2021

Last Update Submit

April 25, 2023

Conditions

Aortic Stenosis

Keywords

Fractional flow reserveDiastolic pressure ratioTranscatheter aortic valve replacement

Outcome Measures

Primary Outcomes (2)

  • Difference between preTAVR dPR specificity and angiography specificity for ischemia

    The difference between PreTAVR dPR specificity (%) - angiography specificity (%), taking post-TAVR FFR as the reference measure.

    Immediately upon completion of the TAVR procedure

  • Diagnostic accuracy

    Establish sufficiently precise estimates (+/- 6.5% around estimate) for the diagnostic accuracy of pre-TAVR dPR expressed in terms of sensitivity and specificity, taking as the reference for ischemia the post-TAVR FFR

    Immediately upon completion of the TAVR procedure

Secondary Outcomes (5)

  • Difference in accuracy between dPR and angiography

    Immediately upon completion of the TAVR procedure

  • Difference in sensitivity between dPR and angiography

    Immediately upon completion of the TAVR procedure

  • Predicting post-TAVR FFR by pre-TAVR FFR

    Immediately upon completion of the TAVR procedure

  • Difference in accuracy between preTAVR dPR and preTAVR FFR

    Immediately upon completion of the TAVR procedure

  • Predicting post-TAVR FFR by pre-TAVR hybrid dPR-FFR

    Immediately upon completion of the TAVR procedure

Other Outcomes (4)

  • Success rate

    Immediately upon completion of the TAVR procedure

  • Freedom from adenosine administration

    Immediately upon completion of the TAVR procedure

  • Percentage of concordance and mean difference between pre- and post-TAVR dPR

    Immediately upon completion of the TAVR procedure

  • +1 more other outcomes

Study Arms (1)

dPR and FFR

Subjects with aortic stenosis who are considered for TAVR will undergo a physiological assessment and prediction of ischemic coronary lesions pre- and post-TAVR by using Opsens non-hyperemic dPR and/or Opsens FFR

Device: dPR and FFR

Interventions

dPR and FFRDEVICE

OpSens non-hyperemic dPR and/or OpSens FFR

dPR and FFR

Eligibility Criteria

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

Subjects who have severe symptomatic aortic stenosis with a formal indication for TAVR, and one or more intermediate coronary lesions in a relevant coronary artery (\>2mm) are considered for this study.

You may qualify if:

  • Subject is at least 18 years old
  • Subject has a degenerative aortic stenosis with mean valvular gradient ≥40 mmHg
  • Subject has a formal heart-team indication for TAVR
  • Subject has one or more stable coronary stenosis lesions 30-90% by visual estimation, in a vessel over 2 mm in diameter, and which is amenable for pressure-wire analysis
  • Subject agrees to participate in the study and is able to sign the informed consent form

You may not qualify if:

  • Subject is unable to provide informed consent
  • Subject has asthma or acute bronchospasm
  • Subject has unstable angina or myocardial infarction
  • Subject meets any contraindication in the applicable OptoWire IFU
  • Subject is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29110, Spain

Location

Hospital Clinico de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Enrique Gutierrez Ibanes, MD

    Hospital Gregoio Maranon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

October 7, 2021

Study Start

September 19, 2022

Primary Completion

March 15, 2023

Study Completion

April 4, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations

ES(5)