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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date July 2020
Source Meshalkin Research Institute of Pathology of Circulation
Contact Alexander V. Bogachev-Prokophiev, MD, PhD
Phone +73833476029
Email bogachev.prokophiev@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

A randomised controlled pilot trial to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy. Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to septal myectomy + edge-to-edge mitral valve repair or isolated septal myectomy. All surgeons were experienced at least 50 related procedures.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
mitral valve repair by edge-to-edge technique
transaortic access for mitral valve repair edge-to-edge
Septal myectomy
isolated extended septal myectomy

Locations

Country Name City State
Russian Federation "E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation Novosibirsk

Sponsors (1)

Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

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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