Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy: Comparison With the Classical Approach

NCT05726799 | Completed

• 1 other identifier: CRYO-MOR
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In some patients, septal hypertrophy extends more distally, from the subaortic portion of the septum to the midventricular portion. In these patients, classic transaortic surgical myectomy may not be effective in removing the midventricular obstruction, resulting in a suboptimal surgical outcome. These patients may present recurrence of symptoms and not have an improvement in the prognosis related to the treatment of hypertrophic cardiomyopathy, in some cases determining the need for reoperation. Since 2015, our Institute has used a surgical technique that allows us to improve transaortic exposure of the interventricular septum, using a probe with application of cryoenergy the hypertrophic portion of the septum is hooked and in this way the myectomy can be extended more distally, performing a more complete removal of the myocardium. The aim of this study is to compare the results obtained with classical myectomy compared to myectomy performed with the aid of cryoenergy. The primary endpoint is the comparison in terms of mortality between patients undergoing classical myectomy versus those undergoing cryoenergy-assisted myectomy. Secondary endpoints are: extent of myectomy, persistence of residual left ventricular outflow tract obstruction, persistence of mitral regurgitation related to systolic anterior motion of the mitral leaflets, occurrence of ventricular defect, and need for PM implantation.

Conditions

Septal Hypertrophy; Obstructive Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Mortality

  Up to 4 years

Study Arms (2)

Cryoenergy

Procedure: Cryo myectomy

Classic Myectomy

Procedure: Myectomy

Interventions

Cryo myectomy PROCEDURE

Extended septal myecotmy using cryo energy

Cryoenergy

Myectomy PROCEDURE

Classic surgical myectomy

Classic Myectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients needing a myectomy due to obstructive hypertrophyc cardiomyopathy

You may qualify if:

• adult patients (≥ 18 years)
• meeting the clinical and echocardiographic criteria that made them candidates for isolated myectomy or in combination with other surgical procedures:
• LV outflow tract instantaneous peak gradient \>50mmHg at rest or during stimulation
• interventricular septum \>16mm,
• NYHA functional class III-IV, despite maximal medical therapy
• operated in San Raffaele Hospital with classic or cryo myectomy between 2015 and 2018.

You may not qualify if:

• extent of myectomy not reported in the operative report;
• left ventricular outflow tract gradient not reported in pre- or postoperative echocardiography.

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Cardiac Surgery of Advanced and Research Therapies

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 14, 2023
• Study Start: October 5, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)