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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT00604903
Eligibility Criteria:
Inclusion Criteria:
* Patients who exhibit signs and symptoms of NYHA Class III or IV heart failure.
* Patients who are able to visit the clinic frequently during the 6 months following implantation.
* Patients who are willing and able to perform all follow-up procedures.
Exclusion Criteria:
1. Patients under the age of 18
2. Pregnant women or women that plan to get pregnant during the study.
3. Patients with, tricuspid or pulmonic stenosis, pulmonary stents, right sided mechanical heart valves
4. Contraindication to antiplatelet therapy (aspirin and clopidogrel)
5. Patients suffering from active infection (on antibiotic therapy)
6. Known intracardiac mass (right atrial or right ventricular)
7. Patients who have been implanted with a VAD
8. Patients who are candidates for listing for heart transplantation if it is deemed that they have a possibility of receiving a heart within the next 6 months
9. Patients that have lead implanted at the heart right side of the heart within the last 6 months
10. Patients with any terminal illness, or with a life expectancy of less than 6 months
11. Patients that are unable to lie flat for the duration of the procedure
12. Patients that are unable to operate the home unit (due to physical or mental constrain)
13. Patients after pneumonectomy
14. Patients treated with oral anticoagulants INR \> 1.5 prior to catheterization
15. Patients with severe chronic renal failure (creatinine \> 2.5 mg/dl)
16. Patients suffered from acute myocardial infarction within the three months prior the study
17. Patients that underwent open heart surgery within 4 weeks prior the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00604903
Study Brief:
Protocol Section:
NCT00604903