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Procedure

TAVR vs SAVR for Severe Aortic Stenosis

N/A

Waitlist Available

Research Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ≥65 years-old diagnosed with severe AS (defined as: jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or velocity ratio <0.25 AND aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2; OR mean gradient >30 mmHg AND aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2 AND >1200 Agatston units for women or >2000 Agatston units for men as determined by non-contrast CT).

Be older than 65 years old

Must not have

Moderate-to-severe tricuspid regurgitation requiring surgical repair

Coronary artery disease (CAD) not treatable by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), or SYNTAX score >32 (in the absence of prior revascularization) or severe left main disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year and 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the outcomes of two different types of heart valve replacement surgery in people with severe aortic stenosis and small aortic annuli.

Who is the study for?

This trial is for people aged 65 or older with severe aortic stenosis and small aortic annuli, confirmed by specific heart measurements. It's not suitable for those at high surgical risk, with certain types of heart disease or valve replacements, untreated coronary artery disease, or significant tricuspid regurgitation.

What is being tested?

The study compares two procedures: transcatheter (TAVR) and surgical aortic valve replacement (SAVR), in patients with severe AS and small aortic annuli. It aims to evaluate which method better improves blood flow issues and clinical outcomes like survival rates, stroke incidence, and major bleeding events.

What are the potential side effects?

Potential side effects include risks associated with heart procedures such as bleeding complications, stroke risk during the operation, infection risks from implants used in TAVR or SAVR methods, irregular heart rhythms, and potential need for pacemaker insertion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 65 and have been diagnosed with severe aortic stenosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery for severe heart valve leakage.

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My heart disease cannot be treated with stenting or bypass surgery.

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I have had surgery to replace or repair an aortic valve.

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My heart valve narrowing is not due to calcium buildup.

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I have been diagnosed with a porcelain aorta.

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I have severe leakage in my heart's mitral valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year and 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year and 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Valve performance: rate of prothesis-patient mismatch (PPM) and/or aortic regurgitation (AR)

Secondary study objectives

Bleeding

Cardiac re-hospitalization

Combined Safety endpoint

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: TAVRExperimental Treatment3 Interventions

The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local abesthesia, Imaging guidance during the TAVR procedure, and post-procedural TAVR management.

Group II: SAVRExperimental Treatment1 Intervention

SAVR procedure will be performed using standard techniques, with no limitation in terms of type and size of the valve prosthesis or surgical procedure (e.g. enlargement of the aortic root).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard

2013

Completed Phase 4

~5340

0 / 7Eligibility criteria met