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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT01294267
Eligibility Criteria:
Inclusion Criteria:
* male or female
* age 18 to 90 years
* catheter ablation of ventricular tachycardia
* Left Ventricular ejection fraction less than or equal to 40% or hypertrophic cardiomyopathy
Exclusion Criteria:
* Any reversible cause of VT \[electrolyte derangements, medication related itc\]
* Evidence of active, ongoing cardiac ischemia as the cause of VT
* Patients who have experienced any cerebral ischemic event including any TIA in the preceding one month
* Mural thrombus in left Ventricle
* Presence of mechanical aortic valve
* Severe Aortic Stenosis \[orifice area of 2.0 cm2 or less\] or moderate to severe aortic insufficiency
* Severe abnormalities of the aorta that would preclude Impella insertion, including aneurysms and extreme tortuosity or calcifications
* Liver dysfunction or markedly abnormal coagulation parameters \[as defined by platelet count less than or equal to 50,000/ul\]
* Any condition resulting in contraindication to anticoagulation \[eg GI bleeding\]
* Women who are known to be pregnant or have had a positive B-HCG test 7 days prior to procedure
* Patients whose life expectancy is less than one year
* Mental Impairment precluding patient or family from providing informed consent or completing the appropriate follow up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01294267
Study Brief:
Protocol Section:
NCT01294267