Heart Disease Trial, Recruiting (NCT05459233)

Heart Disease Trial, Recruiting NCT05459233 Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Condition: Heart Disease

Printed from Voxsanity (voxsanity.com.au) — NCT05459233 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Heart Disease

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

People who have a failing surgically implanted heart valve (a type called a bioprosthetic valve) with severe narrowing and/or leaking of the aortic valve, where the heart team has approved a "valve-in-valve" procedure (placing a new valve inside the existing one)
People whose surgically implanted valve has a frame (stented) and has a labelled size of 25 mm or smaller
People whose planned treatment involves a specific replacement valve device called the SAPIEN 3 Ultra

Who may not be able to join:

People whose existing surgical valve is a stentless or sutureless type (does not have an internal frame)
People whose existing surgical valve is a Trifecta bioprosthesis (a specific brand/model of valve)
People whose existing surgical valve is a Hancock II bioprosthesis (another specific brand/model of valve)
People where scans show a high risk that the new valve could block blood flow to the coronary arteries (the vessels that supply the heart with blood), based on measurements or the judgment of the heart team (confirm with trial site)
People who are unable to provide written consent to participate in the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 21 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Josep Rodés-Cabau, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Phone: 418-656-8711

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT05459233

Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Phase: Not Applicable

Status: Recruiting

Condition: Heart Disease

Trial contact: 418-656-8711

More information: https://clinicaltrials.gov/study/NCT05459233

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

People who have a failing surgically implanted heart valve (a type called a bioprosthetic valve) with severe narrowing and/or leaking of the aortic valve, where the heart team has approved a "valve-in-valve" procedure (placing a new valve inside the existing one)
People whose surgically implanted valve has a frame (stented) and has a labelled size of 25 mm or smaller
People whose planned treatment involves a specific replacement valve device called the SAPIEN 3 Ultra

Who may not be able to join:

People whose existing surgical valve is a stentless or sutureless type (does not have an internal frame)
People whose existing surgical valve is a Trifecta bioprosthesis (a specific brand/model of valve)
People whose existing surgical valve is a Hancock II bioprosthesis (another specific brand/model of valve)
People where scans show a high risk that the new valve could block blood flow to the coronary arteries (the vessels that supply the heart with blood), based on measurements or the judgment of the heart team (confirm with trial site)
People who are unable to provide written consent to participate in the trial

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 21 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Registry

ClinicalTrials.gov

Start date

11 January 2023

Est. completion

1 September 2027

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Changes in Quality of life (Efficacy); Periprocedural complications (Safety)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov