Evaluation of ARi With OpSens SavvyWire

NCT06295068 | Terminated FDA Device

• 1 other identifier: PRT-1400-11
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography.

Conditions

Aortic Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

• Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography

  From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours

Secondary Outcomes (2)

• Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography

  From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours

• Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography

  From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours

Interventions

Transcatheter Aortic Valve Replacement (TAVR) DEVICE

Replacement of the aortic valve with use of the OpSens SavvyWire

Balloon Aortic Valvuloplasty (BAV) DEVICE

Dilation of the narrowed aortic valve by balloon inflation with use of the OpSens SavvyWire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention

You may qualify if:

• Patients undergoing TAVR suitable for intraoperative acquisition of TEE/TTE
• Age \> 18 years
• Able and willing to give informed consent.

You may not qualify if:

• Hemodynamic instability making use of additional hemodynamic measurement inappropriate or 24-hour survival unlikely
• Subject is considered part of a vulnerable population.

Sponsors & Collaborators

• Opsens, Inc.: lead

Study Sites (1)

AHS Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Philippe Généreux, Dr

  AHS Morristown Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: March 6, 2024
• Study Start: November 30, 2023
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)