NCT03906734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

January 20, 2019

Last Update Submit

April 5, 2019

Conditions

Hypertrophic Cardiomyopathy

Keywords

septal myectomyhypertrophic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Transmitral pressure gradient

    Transmitral pressure gradient after the procedures assessed by echocardiography

    30-days

Secondary Outcomes (3)

  • Repeat bypass

    30 day

  • Residual left ventricle outflow tract gradient

    intraoperative measuerment

  • Early mortality

    30 days

Study Arms (2)

alfieri technique + Septal myectomy

EXPERIMENTAL

Septal myectomy plus mitral valve repair using alfieri stich

Procedure: Septal myectomyProcedure: alfieri stich

Subvalvular intervention + Septal myectomy

ACTIVE COMPARATOR

Septal myectomy plus subvalvular mitral valve intervention

Procedure: Septal myectomyProcedure: Subvalvular intervention

Interventions

Septal myectomyPROCEDURE

Transaortic septal myectomy

Subvalvular intervention + Septal myectomyalfieri technique + Septal myectomy
alfieri stichPROCEDURE

Transaortic Mitral valve repair using alfieri technique

alfieri technique + Septal myectomy
Subvalvular interventionPROCEDURE

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

Subvalvular intervention + Septal myectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Intrinsic valvular heart disease
  • Coronary artery disease
  • Aortic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2019

First Posted

April 8, 2019

Study Start

January 10, 2016

Primary Completion

October 28, 2016

Study Completion

March 20, 2019

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Restricted by local policy

Locations

RU(1)