Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05103267
Eligibility Criteria:
Inclusion Criteria:
Patient is at least 18 years of age, willing to sign and date the study PIC form and is planned to undergo at least one of the following:
1. Patient suffering from heart failure (FE\<35%) undergoing de novo single or dual-chamber ICD or CRT-D system implant according to the most recent European Society of Cardiology guidelines
2. Patient suffering from heart failure (FE\<35%) with a pre-existing CIED and planned to undergo ICD or CRT-D replacement or upgrading.
3. Antibiotic prophylaxis before procedure, surgical preparation with alcoholic chlorhexidine or povidone-iodine, measures to avoid pocket haematoma (avoid heparin bridging, discontinue antiplatelets if possible excluding cardioaspirin) according to current guidelines.
Exclusion Criteria:
1. Life expectancy of \< 12 months or planned to undergo heart transplantation within 6 months.
2. Prior history of CIED infection, including endocarditis, in the past 12 months.
3. Clinical or laboratory sign or symptoms of active infection
4. Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to device procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05103267
Study Brief:
Protocol Section:
NCT05103267