In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation

NCT06859255 | Recruiting FDA Device

• 1 other identifier: PNRR-MCNT2-2023-12378350
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques. The study involves the collection of data deriving from tests and procedures foreseen by normal clinical practice, including a transthoracic color Doppler echocardiogram, to which is added a 4DFlow cardiac MRI (magnetic resonance imaging) without contrast medium, to be performed between 1 and 3 months after the operation. The study will last 24 months and the patients involvement will end approximately 1-3 months after the intervention. There are no direct benefits expected from participation in the study. However, the instrumental data obtained by echocardiogram and Magnetic Resonance Imaging will be useful for monitoring the medium-term surgical outcome of patients after surgery.

Conditions

Severe Aortic Valve Stenosis

Keywords

aortic valve stenosis; valve replacement; TAVI; hemodynamic; 4d flow; cardiac echo; cardiac RMN; aortic valve; TAVR

Outcome Measures

Primary Outcomes (5)

• Bench tests performance

  Pressure gradient after valve implantation in vitro

  24 months

• MRI in vitro

  Blood flow pattern of aortic in vitro models under 4D flow MRI

  24 months

• Echo in vivo

  Morphology of the bioprosthetic valve leaflets will be evaluated in vivo through an Echo

  24 months

• Echo in vivo

  Motiliy of the bioprosthetic valve leaflets will be evaluated in vivo through an Echo

  24 months

• RMN in vivo

  Blood flow pattern of implanted valves will be evaluated in vivo through a MRI 4 flow

  24 months

Study Arms (1)

Aortic Valve Replacement Patient

EXPERIMENTAL

Inclusion criteria: * evaluation of patients who underwent SAVR or TAVI for severe aortic stenosis * implanted with valve models and sizes among those which we evaluated in vitro. Exclusion criteria: * treated or untreated aortic root/ascending aorta aneurysm * preoperative aortic regurgitation more than moderate * recent (\<12 weeks)/ concomitant revascularization or recent (\<12 weeks) ACS Timing of trans-thoracic echocardiography (TTE) and MRI: 1 to 3 months after SAVR/TAVR. Intervention: MRI, it is not clinical practice during 1 month follow-up. Clinical Variables: in order to reduce clinical bias in the comparison of the two populations, at the moment of TTE exam, blood pressure, heart rate and haemoglobin values will be recorded.

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

The patients will be undergo to a MRI without contrast after 1 month from the procedure/surgery to test the hwmodynamic performance 4d flow in the implanted valve

Aortic Valve Replacement Patient

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who underwent SAVR or TAVI for severe aortic stenosis
• implanted with valve models and sizes among those which we evaluated in vitro

You may not qualify if:

• treated or untreated aortic root/ascending aorta aneurysm
• preoperative aortic regurgitation more than moderate
• recent (\<12 weeks)/ concomitant revascularization
• recent (\<12 weeks) ACS
• PPI (permanent pacemaker implantation)
• other than sinus rythm
• Paravalvular leak (PVL) \> moderate.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (2)

Policlinico di Bari

Bari, Apulia, 70100, Italy

ACTIVE NOT RECRUITING

IRCCS Policlinico San Donato

San Donato, Lombardy, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Agnese Rossi, Study Coordinator

CONTACT

00393409009040; agnese.rossi@grupposandonato.it

Giacomo Bortolussi, Researcher - Cardiac Surgeon

CONTACT

003900393246943755; giacomo.bortolussi@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: March 5, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): February 7, 2027
• Study Completion (Estimated): February 7, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

IT (2)