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Blood Pressure Cuff Inflation for Aortic Valve Surgery

N/A

Waitlist Available

Led By Pierre Voisine, MD

Research Sponsored by Laval University

Eligibility Criteria Checklist

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

Must have

Planned isolated aortic valve replacement (stenosis based)

Age ≥ 18 years

Must not have

Coronary artery disease (documented with >50% stenosis)

TAVI procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, 24 and 48 hours post-operatively

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a simple, non-invasive procedure can help protect the heart during surgery.

Who is the study for?

This trial is for adults over 18 who need an aortic valve replacement due to stenosis. It's not suitable for pregnant individuals, those with recent heart attacks, severe left ventricular dysfunction, endocarditis, previous sternotomy, limb deep vein thrombosis, emergency cases or certain other heart and kidney conditions.

What is being tested?

The study tests if inflating a blood pressure cuff on the arm before surgery can protect the heart during aortic valve replacement. This non-invasive technique is called remote ischemic preconditioning.

What are the potential side effects?

Potential side effects may include discomfort or bruising where the blood pressure cuff is applied. Since this procedure is non-invasive and localized, significant side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for a heart valve replacement due to narrowing.

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I am 18 years old or older.

Exclusion Criteria

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

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I have been diagnosed with significant blockage in my heart's arteries.

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I have undergone a TAVI procedure.

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I have a blood clot in a vein of my compressed limb.

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I am scheduled for a heart bypass surgery without using a heart-lung machine.

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My heart's left ventricle is not pumping well.

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I have chronic kidney problems or am on dialysis.

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I require an emergency medical procedure.

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I have undergone a MAZE procedure for my heart.

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I have had a heart attack in the last 7 days.

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I have had a previous open-heart surgery.

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I have been diagnosed with endocarditis.

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I have had heart bypass surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12, 24 and 48 hours post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 12, 24 and 48 hours post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 24 and 48 hours post-operatively for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in biochemical markers of myocardial ischemia

Secondary study objectives

Post-operative complications

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

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 200 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.

Group II: Control groupActive Control1 Intervention

Sham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass. A 20 mm Hg blood pressure cuff on the right arm does not induce ischemia.

0 / 14Eligibility criteria met