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Comparison of heart workload during exercise after a Ross procedure and a mechanical valve replacement

Ross Assessment and Cardiac workload during Exercise trial

Status
Unknown
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN93574260
Enrollment
50
Registered
2021-07-07
Start date
2016-03-01
Completion date
Unknown
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of exercise on the heart in patients who underwent a surgical aortic valve replacement with either a mechanical prosthesis or a Ross procedure Circulatory System

Interventions

For patient selection, 2 cohorts of patients who underwent aortic valve replacement with either a Ross procedure or a mechanical prosthesis were matched according to age, sexe, aortic valve disease, a

Sponsors

Montreal Heart Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All adults between 18 and 64 years old who underwent AVR with mechanical prosthesis or with Ross procedure at our institution between 2007 and 2016.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled hypertension at rest (>150/90 mmHg) 2. LVEF 50 mmHg) 7. Atrial fibrillation 8. Cardiovascular complications (stroke, transient ischemic attack, myocardial infarction, pericardial effusion, heart failure, malignant arrhythmias) within the last 3 months 9. Patients with a permanent pacemaker 10. More than moderate mitral insufficiency 11. Contraindication to MRI 12. Impossibility to perform a stress test on an ergocycle (limiting physical capacities)

Design outcomes

Primary

MeasureTime frame
Left ventricular workload estimated by the valvulo-arterial impedance (Zva) measured at rest and during exercise. (The valvulo-arterial impedance equals the sum of the systolic blood pressure (sBP) and the mean aortic valve gradient divided by the stroke volume index: Zva= [sBP + mean AV gradient] / Stroke volume index. All the 3 parameters are measured at the same time during echocardiography and CMRI.)

Secondary

MeasureTime frame
1. Energy Loss Index (ELI) calculated as [(AVAxAa)/(Aa-AVA)]/BSA at rest and during exercise 2. Aortic valve area (AVA) measured by transthoracic echocardiogram (TTE) and MRI at rest and during exercise 3. Ascending aorta crossectional area (Aa) measured by TTE and MRI at rest and during exercise 4. Left ventricular stroke work (LVSW) calculated as (MAP + mean AV gradient) x Stroke volume x 0.0136 at rest and during exercise 5. Aortic valve gradients measured by TTE and MRI at rest and during exercise 6. LV diameters and volumes measured by TTE and MRI at rest and during exercise 7. LV ejection fraction measured by TTE and MRI at rest and during exercise 8. MAP, systolic arterial pressure, diastolic arterial pressure, heart rate at rest and during exercise

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026