Mitral Valve Management During Septal Myectomy

Alfieri Stich Versus Secondary Cord Cutting During Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy: A Pilot Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03906734

Acronym

MVMSM

Enrollment

Registered

2019-04-08

Start date

2016-01-10

Completion date

2019-03-20

Last updated

2019-04-08

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

Conditions

Hypertrophic Cardiomyopathy

Keywords

septal myectomy, hypertrophic cardiomyopathy

Brief summary

Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

Detailed description

There is pilot prospective randomised study comparing immediate and early results of additional subvalvular mitral apparatus intervention versus additional alfieri stich in patients scheduled to septal myectomy for symptomatic 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 alfieri stich or secondary cord cutting. All surgeons were experienced at least 50 related procedures.

Interventions

PROCEDURESeptal myectomy

Transaortic septal myectomy

PROCEDUREalfieri stich

Transaortic Mitral valve repair using alfieri technique

PROCEDURESubvalvular intervention

Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Hypertrophic obstructive cardiomyopathy * Left ventricle outflow tract gradient \> 50 mm Hg at rest * Systolic anterior motion mediated mitral regurgitation

Exclusion criteria

* Intrinsic valvular heart disease * Coronary artery disease * Aortic disease

Design outcomes

Primary

Measure	Time frame	Description
Transmitral pressure gradient	30-days	Transmitral pressure gradient after the procedures assessed by echocardiography

Secondary

Measure	Time frame	Description
Repeat bypass	30 day	Rate of second cross clamping and repeating bypass for procedure related reasons
Residual left ventricle outflow tract gradient	intraoperative measuerment	Residual left ventricle outflow tract gradient assessed by direct measurement
Early mortality	30 days	All cause death during 30 days

Countries

Russia

Outcome results

None listed

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