NCT04904393

Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry

Subanalysis in Patients With CARDIoLAMinopathy Enrolled to Retrospective and Observational Registy on Cardiac Contractility Modulation Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Monaldi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Observational, retrospective registry with acute and chronic endpoints

Detailed description

This registry includes patients who have undergone CCM device implant and due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, with LMNA-DCM etiology for to assess the impact on CCM therapy in term of improvemente of QoL and reduction HF hospitalizations

Conditions

• Laminopathy
• Lamin A/C Gene Mutation
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Implant of the device for Cardiac Contractility Modulation (CCM) Therapy	The intervention is an implant of CCM therapy devices and it is similar to conventional dual chamber cardiac devices with only difference of to insert n 2 leads fixed in right ventricular septum

Timeline

• Start date: 2021-03-08
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-05-27
• Last updated: 2021-05-27

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study