OpSens PRIME CLASS

OpSens dPR for Physiological Assessment of Intermediate Coronary Lesions in Aortic Stenosis

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: dPR and FFR

Detailed Description

This is a post-marketing, prospective, observational, single arm, multi-center, single country study in 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). This study aims to assess if OpSens non-hyperemic dPR (based on a proprietary algorithm) and/or OpSens FFR are suitable methods for the physiological assessment and prediction of ischemic coronary lesions in Subjects with aortic stenosis who are considered for TAVR. This will be done by comparing pre-TAVR measurements of angiography, dPR and FFR and placing them against the post-TAVR FFR, which is considered as the gold standard. Also the post TAVR dPR will be compared with post-TAVR FFR.

A maximum of 137 subjects will be enrolled in 5 to 10 sites in Spain to obtain the required minimum of 137 lesions (see section 11.2 Sample Size Determination) The main hypothesis is that the specificity to predict ischemic lesions in TAVR candidates based on a pre-TAVR dPR ≤ 0.89 is superior compared to the specificity based on angiography alone (both QCA and visual assessment of the stenosis >50%), taking the post-TAVR FFR value of ≤ 0.80 as a reference for positive lesions.

The pressure guidewire used to measure dPR and FFR during diagnostic angiography is the commercially available (CE-marketed) OptoWire family of pressure guidewires from OpSens Inc.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Spain
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Madrid, Spain, 28007
    • Hospital Gregorio Marañon
  • Malaga, Spain, 29110
    • Hospital Virgen de la Victoria
  • Santiago De Compostela, Spain, 15706
    • Hospital Clínico de Santiago
  • Valladolid, Spain, 47011
    • Hospital Clinico Universitario de Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; OpSens non-hyperemic dPR and/or OpSens FFR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in accuracy between dPR and angiography	The difference between the percentage of lesions correctly classified by preTAVR dPR and the percentage of lesions correctly classified by angiography, always taking postTAVR FFR as the reference measure.	Immediately upon completion of the TAVR procedure
Difference in sensitivity between dPR and angiography	The difference between the sensitivity of preTAVR dPR and the sensitivity of angiography, where: preTAVR sensitivity= preTAVR True positive/ (preTAVR true positive+ preTAVR false negative) * 100; angiography sensitivity= angiography True positive/ (angiography true positive+ angiography false negative) * 100, taking post-TAVR FFR as the reference measure.	Immediately upon completion of the TAVR procedure
Predicting post-TAVR FFR by pre-TAVR FFR	Overall diagnostic accuracy of preTAVR FFR, defined as the percentage of lesions correctly classified by pre-TAVR FFR, taking postTAVR FFR as the reference measure.	Immediately upon completion of the TAVR procedure
Difference in accuracy between preTAVR dPR and preTAVR FFR	The difference in the overall diagnostic accuracy of pre-TAVR dPR and pre-TAVR FFR to predict a post-TAVR FFR ≤ 0.80	Immediately upon completion of the TAVR procedure
Predicting post-TAVR FFR by pre-TAVR hybrid dPR-FFR	Overall diagnostic accuracyof a pre-TAVR hybrid dPR-FFR based approach to predict a post-TAVR FFR ≤ 0.80	Immediately upon completion of the TAVR procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	The success rate of the dPR & FFR procedure, defined as the percentage of cases in which dPR and FFR could be measured, and no procedural complications occurred	Immediately upon completion of the TAVR procedure
Freedom from adenosine administration	The percentage of Subjects who can be spared the administration of adenosine by a hybrid dPR-FFR strategy, while maintaining an overall diagnostic accuracy ≥ 90%	Immediately upon completion of the TAVR procedure
Percentage of concordance and mean difference between pre- and post-TAVR dPR	Percentage of concordance and mean difference between pre- and post-TAVR dPR	Immediately upon completion of the TAVR procedure
Percentage of concordance and mean difference between pre- and post-TAVR FFR	Percentage of concordance and mean difference between pre- and post-TAVR FFR	Immediately upon completion of the TAVR procedure

Collaborators and Investigators

• Sponsor: Opsens, Inc.
• Investigators: Principal Investigator: Enrique Gutierrez Ibanes, MD, Hospital Gregoio Maranon

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Fractional flow reserve; Transcatheter aortic valve replacement; Diastolic pressure ratio
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: PRIME CLASS

Drug and device information, study documents

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