Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy

NCT04470102 — Not applicable, Unknown, 40 participants, Meshalkin Research Institute of Pathology of Circulation

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A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy

Registry	NCT04470102, acronym PRIZMA-pilot
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	Meshalkin Research Institute of Pathology of Circulation (Network)
Conditions	Hypertrophic Obstructive Cardiomyopathy
Interventions	mitral valve repair by edge-to-edge technique, Septal myectomy (Procedure)
Dates	start 2020-03-12, primary completion 2021-01-31 (estimated), completion 2022-01-31 (estimated), first posted 2020-07-14, last updated 2020-07-21
Locations	1 site in Russia

-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.

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
isolated septal myectomy	Other	Procedure: Septal myectomy	Isolated extended septal myectomy
Septal myectomy+ "edge-to-edge"	Active comparator	Procedure: mitral valve repair by edge-to-edge technique	advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique

mitral valve repair by edge-to-edge technique (Procedure), also known as Alfieri stitch: transaortic access for mitral valve repair edge-to-edge
Septal myectomy (Procedure), also known as Septal myectomy (SM): isolated extended septal myectomy

+Outcome measures

Primary outcomes

Left Ventricular Outflow Tract (LVOT) gradient [12 months in the medium-term follow-up]: 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.

Secondary outcomes

Systolic anterior motion of the mitral valve [12 months in the medium-term follow-up]: Systolic anterior motion of the mitral valve after surgery This measurement will be performed by transthoracic echocardiography at rest and / or during exercise.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation	Novosibirsk	Russia	Recruiting

+Investigators

Alexander V. Bogachev-Prokophiev, MD, PhD, Principal investigator, E.Meshalkin National medical research center