Alfieri Stich Versus Secondary Cord Cutting During Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy: A Pilot Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Transmitral pressure gradient
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Transmitral pressure gradient
Time Frame: 30-days
Transmitral pressure gradient after the procedures assessed by echocardiography
Secondary Outcomes
- Residual left ventricle outflow tract gradient(intraoperative measuerment)
- Early mortality(30 days)
- Repeat bypass(30 day)