Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05562804
Status:
RECRUITING
Last Update Posted:
2022-10-04
First Post:
2022-09-28
Brief Title:
Mitral Valve Prolapse Arrhythmias and Mitral Valve Surgery
Sponsor:
Ospedale San Raffaele
Organization:
Ospedale San Raffaele
Study Overview
Official Title:
Electrophysiological Substrate in Patients With Barlows Disease Clinical Predictors of Arrhythmic Events and Impact of Mitral Surgery
Status:
RECRUITING
Status Verified Date:
2022-10
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:
MVP-AS
Brief Summary:
Mitral valve prolapse MVP is associated with malignant ventricular arrhythmias VA and sudden cardiac death A proper electrophysiological and echocardiographic characterization of this population is missing Moreover the effects of mitral valve repair on the arrhythmic burden are still matter of debate
The investigators sought to explore the role of the arrhythmic substrate in the risk stratification of patients with MVP and to assess whether mitral surgery is followed by a significant modification of the baseline arrhythmic pattern
The investigators sought to explore the role of the arrhythmic substrate in the risk stratification of patients with MVP and to assess whether mitral surgery is followed by a significant modification of the baseline arrhythmic pattern
Detailed Description:
This is a prospective observational study enrolling 200 patients with MVP and any documented VA
Diagnosis of VA obtained by 12 leads ECG and Holter recordings will be reported as well as preprocedural premature ventricular contractions PVC burden assessed by 24-hour Holter monitoring demographic and clinical data will be collected including symptoms documentation of VA and atrial fibrillation AF Echocardiography data will be analyzed focusing on mitral regurgitation grading and mitral valve morphology analysis assessment of leaflet redundancy and prolapse chordal elongation annular dilatation presence of calcifications and mitral annular disjunction characterization
Patients will undergo ECG Holter monitoring before Cardiac Surgery with the aim to identify any VA and estimate PVC burden ECG Holter monitoring will be repeated at 3 9 and 12 months after cardiac surgery In case of intraoperative biopsy the result of histopathological examination will be collected For patients undergoing cardiac imaging including Cardiac Magnetic Resonance or Computer Tomography data regarding cardiac volumes function markers of fibrosis will be collected In patients undergoing Programmed electrical stimulation PES and Electroanatomical Mapping EAM size of bipolar and unipolar endocardial abnormal voltage areas Late Potentials LP area results of programmed electrical stimulation will be evaluated
Diagnosis of VA obtained by 12 leads ECG and Holter recordings will be reported as well as preprocedural premature ventricular contractions PVC burden assessed by 24-hour Holter monitoring demographic and clinical data will be collected including symptoms documentation of VA and atrial fibrillation AF Echocardiography data will be analyzed focusing on mitral regurgitation grading and mitral valve morphology analysis assessment of leaflet redundancy and prolapse chordal elongation annular dilatation presence of calcifications and mitral annular disjunction characterization
Patients will undergo ECG Holter monitoring before Cardiac Surgery with the aim to identify any VA and estimate PVC burden ECG Holter monitoring will be repeated at 3 9 and 12 months after cardiac surgery In case of intraoperative biopsy the result of histopathological examination will be collected For patients undergoing cardiac imaging including Cardiac Magnetic Resonance or Computer Tomography data regarding cardiac volumes function markers of fibrosis will be collected In patients undergoing Programmed electrical stimulation PES and Electroanatomical Mapping EAM size of bipolar and unipolar endocardial abnormal voltage areas Late Potentials LP area results of programmed electrical stimulation will be evaluated
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