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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 24 and 48 hours post-operatively
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am scheduled for a heart valve replacement due to narrowing.
Select...
I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in biochemical markers of myocardial ischemia
Secondary outcome measures
Post-operative complications

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.

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecOTHER
36 Previous Clinical Trials
9,602 Total Patients Enrolled
4 Trials studying Aortic Valve Stenosis
625 Patients Enrolled for Aortic Valve Stenosis
Laval UniversityLead Sponsor
417 Previous Clinical Trials
172,132 Total Patients Enrolled
4 Trials studying Aortic Valve Stenosis
870 Patients Enrolled for Aortic Valve Stenosis
Pierre Voisine, MDPrincipal InvestigatorUniversity Laval
2 Previous Clinical Trials
661 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
251 Patients Enrolled for Aortic Valve Stenosis

Media Library

Blood pressure cuff inflation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03305094 — N/A
Aortic Valve Stenosis Research Study Groups: Control group, Intervention group
Aortic Valve Stenosis Clinical Trial 2023: Blood pressure cuff inflation Highlights & Side Effects. Trial Name: NCT03305094 — N/A
Blood pressure cuff inflation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03305094 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still signing up for this research project?

"At present, this medical trial is not in search of participants. Initially posted on April 11th 2014 and last updated August 18th 2022; however, there are currently 179 other studies recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery
Pierre Voisine 2014. "The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03305094.
All > Aortic Stenosis
~13 spots leftby Apr 2025
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