Hypertrophic Obstructive Cardiomyopathy Clinical Trial
— PRIZMA-pilotOfficial title:
A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
NCT number | NCT04470102 |
Other study ID # | 188 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 12, 2020 |
Est. completion date | January 31, 2022 |
Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Provide written informed consent (either from the patient or a substitute decision-maker) - Indications for surgical treatment (septal myectomy) of hypertrophic cardiomyopathy Exclusion Criteria: - indications for mitral valve replacement - Patient failure at any stage of the study |
Country | Name | City | State |
---|---|---|---|
Russian Federation | "E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation | Novosibirsk |
Lead Sponsor | Collaborator |
---|---|
Meshalkin Research Institute of Pathology of Circulation |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left Ventricular Outflow Tract (LVOT) gradient | Gradient at the level of the output section of the left ventricle after surgery (mmHg) This measurement will be performed by transthoracic echocardiography at rest and / or during exercise. The Doppler method will be used. | 12 months in the medium-term follow-up | |
Secondary | Systolic anterior motion of the mitral valve | Systolic anterior motion of the mitral valve after surgery This measurement will be performed by transthoracic echocardiography at rest and / or during exercise. | 12 months in the medium-term follow-up |
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