Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05726799
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2023-01-26
Brief Title:
Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy Comparison With the Classical Approach
Sponsor:
Michele De Bonis
Organization:
Ospedale San Raffaele
Study Overview
Official Title:
Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy Comparison With the Classical Approach
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None