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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year and 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 65 and have been diagnosed with severe aortic stenosis.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Valve performance: rate of prothesis-patient mismatch (PPM) and/or aortic regurgitation (AR)
Secondary outcome measures
Bleeding
Cardiac re-hospitalization
Combined Safety endpoint
+11 moreTrial 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
Find a Location
Who is running the clinical trial?
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecLead Sponsor
36 Previous Clinical Trials
9,442 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery for severe heart valve leakage.My heart disease cannot be treated with stenting or bypass surgery.I have had surgery to replace or repair an aortic valve.I am over 65 and have been diagnosed with severe aortic stenosis.My doctors have decided surgery is too risky for me.My heart valve narrowing is not due to calcium buildup.I have been diagnosed with a porcelain aorta.I have severe leakage in my heart's mitral valve.Your aortic root is larger than 45 millimeters.Your aortic annulus is smaller than 23mm in diameter as measured by a special type of scan.
Research Study Groups:
This trial has the following groups:- Group 1: SAVR
- Group 2: TAVR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of participation in this clinical experiment?
"Affirmative. The information on clinicaltrials.gov suggests that this trial is currently searching for patients to enroll, having first been posted on May 30th 2017 and edited as recently as July 7th 2022. This medical research requires 300 participants to be recruited from 1 site."
Answered by AI
Is this research undertaking actively seeking participants?
"Affirmative. According to clinicaltrials.gov, this trial is currently seeking participants for recruitment and began on May 30th 2017 with a most recent update as of July 7th 2022. The study seeks 300 individuals from one location."
Answered by AI
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