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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04470102

Acronym

PRIZMA-pilot

Enrollment

Registered

2020-07-14

Start date

2020-03-12

Completion date

2022-01-31

Last updated

2020-07-21

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

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

edge-to-edge repair, mitral valve plastic (MVP), Septal myectomy

Brief 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.

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.

Interventions

PROCEDUREmitral valve repair by edge-to-edge technique

transaortic access for mitral valve repair edge-to-edge

PROCEDURESeptal myectomy

isolated extended septal myectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

no data

Intervention model description

A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Russia

Contacts

Primary ContactAlexander V. Bogachev-Prokophiev, MD, PhD

bogachev.prokophiev@gmail.com+73833476029

Backup ContactSergei A. Budagaev

ser.bud.med@gmail.com+73833476029

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026