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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05726799
Enrollment
60
Registered
2023-02-14
Start date
2019-10-05
Completion date
2019-10-15
Last updated
2023-02-14

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

Conditions

Obstructive Hypertrophic Cardiomyopathy, Septal Hypertrophy

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.

Interventions

PROCEDURECryo myectomy

Extended septal myecotmy using cryo energy

PROCEDUREMyectomy

Classic surgical myectomy

Sponsors

Michele De Bonis
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
MortalityUp to 4 years

Countries

Italy

Outcome results

None listed

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