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:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT05006157
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 21
2. Electrophysiological diagnostic (mapping) and/or therapeutic (ablation) of epicardial sites via percutaneous subxiphoid approach to the to the normal, non-distended ericardial space is indicated.
3. Pre-treatment coagulation values within the following limits:
* international normalized ratio 0.8 - 1.2
* partial thromboplastin time 25 - 35''
4. Pre-treatment hematology and biochemistry values within the following limits:
* hemoglobin ≥ 10 g/dL (g/100 mL)
* platelets ≥ 150 x 10\^9/L (x 10\^3/mm\^3)
* white blood cells ≥ 3.0 x 10\^9/L (x 10\^3/mm\^3)
* absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (1.5 x 10\^3/mm\^3)
* serum creatinine \< 1.5 mg/dL
* aspartate aminotransferase \< 1.5 x ULN (upper limit of norm)
* alanine aminotransferase \< 1.5 x ULN
* alkaline phosphatase \< 1.5 x ULN
5. Signed informed consent.
Exclusion Criteria:
* History of cardiac or pericardial surgery or prior pericardial ablation.
* History of chronic pericarditis.
* Known pericardial fibrosis and/or adhesions.
* Any anomaly in the chest anatomy.
* Myocardial infarction, past or present.
* Bleeding disorders.
* Hepatic enlargement.
* BMI \> 40
* Participation in another interventional trial.
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05006157
Study Brief:
Protocol Section:
NCT05006157