NCT05764109

Adherence to Cied Implantation Guidelines and Cardiac Rehabilitation

AdhereNce to Cied Implantation GuidELInes: Cardiac rehAbilitation as a Window on Time-dependent Indications: an Observational Prospective Study (ANGELICA).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 488 (actual)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

There are limited data on how the guideline indications for ICD implantation are applied in clinical practice across Europe. Moreover, the impact of "time-dependence" of some indications to implantation on the guidelines adherence is still unknown. Objective of the present observational study is the evaluation of the adherence to the scientific guidelines in patients with a time-dependent indication to ICD/CRT-D implantation admitted to an in-hospital cardiac rehabilitation program.

Detailed description

Current guidelines recommend ICD implantation in patients at high risk of sudden cardiac death with either ischemic or non-ischemic heart disease. However, implantation rate of cardiac implantable electrical devices (CIED), especially ICD, CRT and CRT-D, is lower than expected and do not reflect guideline indications. Several factors may justify the differences in ICD implantation rates across Europe and the gap between daily clinical practice and guidelines: economic restrictions, poor guidelines awareness, especially among referring cardiologists and general practitioners, and different guidelines adherence. The impact of "time-dependence" of some indications to CIED implantation on the guidelines adherence is still unknown. Objective of the present observational study will be the evaluation of the adherence to the scientific guidelines in patients with a time-dependent indication to ICD/CRT-D implantation admitted to an in-hospital cardiac rehabilitation program. This is a prospective, multicenter, observational study performed in 6 cardiac rehabilitation facilities.

Conditions

• Left Ventricular Systolic Dysfunction
• Myocardial Infarction

Timeline

• Start date: 2019-09-15
• Primary completion: 2023-12-29
• Completion: 2025-01-28
• First posted: 2023-03-10
• Last updated: 2025-01-29

Locations

1 site across 1 country: Italy