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Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry (CARDILAM-CCM)

M

Monaldi Hospital

Status

Unknown

Conditions

Laminopathy
Heart Failure
Lamin A/C Gene Mutation

Treatments

Device: Implant of the device for Cardiac Contractility Modulation (CCM) Therapy

Study type

Observational

Funder types

Other

Identifiers

NCT04904393
CCM-002Mon

Details and patient eligibility

About

Observational, retrospective registry with acute and chronic endpoints

Full 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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or non-pregnant female, aged 18 or older;
  • chronic heart failure with symptomatic left ventricular systolic function (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker);
  • Appropriate and optimized medical therapy;
  • Patient signed and dated informed consent form at enrollment;
  • life expectancy> 1 year due to the absence of comorbidities that reduce the prognosis

Exclusion criteria

  • absence of venous access available for implant;
  • contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale);
  • pregnant patients

Trial contacts and locations

1

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Central trial contact

Giuliano D'Alterio, MD; Antonio D'Onofrio, MD

Data sourced from clinicaltrials.gov

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