Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry

NCT04904393 | Unknown FDA Device

• 1 other identifier: CCM-002Mon
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Observational, retrospective registry with acute and chronic endpoints

Conditions

Laminopathy; Lamin A/C Gene Mutation; Heart Failure

Keywords

Heart Failure; Cardiac Contyractility Modulation; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Improvement of QoL

  Evaluation of the effect of CCM therapy on Quality of Life evaluated from the reduction of MLWHFQ score at FU post implant of CCM device compared to baseline.

  12 months

• Reduction of HF Hospitalizations and Emergency Ward accesses

  Reduction of HF Hospitalizations and Emergency Ward accesses collected during the FU post implant of CCM device compared to number of Hospitalizations and Emergenncy Ward accesses collected 1 year before the implant of CCM therapy device

  12 months

• Improvement of Fuctional Capacity

  Evaluation of the impact of CCM therapy on Functional Capacity evaluated from the gain of the distance travelled in the 6MWT at FU post implant of CCM therapy device compared to baseline

  12 months

Secondary Outcomes (1)

• Assess of HF biomarkers trends

  12 months

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with standard indication to CCM therapy device implantation with Cardiolaminopahy aetiology and in HF status.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monaldi Hospital: lead

Study Sites (1)

AO dei Colli - Monaldi Hospital

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Laminopathies; Heart Failure

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Cardiovascular Diseases

Study Officials

• Antonio D'Onofrio, MD

  Ao dei Colli - Monaldi Hospital

  STUDY DIRECTOR

Central Study Contacts

Antonio D'Onofrio, MD

CONTACT

+39 0817062605; donofrioant1@gmail.com

Giuliano D'Alterio, MD

CONTACT

+39 0817062605; gdalterio@libero.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of UOSD Elettrofisiologia Studio e Terapia delle Aritmie

Study Record Dates

• First Submitted: May 15, 2021
• First Posted: May 27, 2021
• Study Start: March 8, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: May 27, 2021

Record last verified: 2021-05

Locations

IT (1)