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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01365234
Eligibility Criteria:
Inclusion Criteria:
* Patient meets CRT inclusion criteria as determined by local regulatory and/or hospital policy
* Patient has signed and dated the study-specific informed consent form
* Patient is 18 years of age or older
* Patient is expected to remain available for follow-ups at the investigational center
* Patient is willing and able to comply with protocol
Exclusion Criteria:
* Patient has a previous complete atrial based biventricular CRT system
* Patient has a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing Adverse Events from previous unsuccessful attempt
* Patient has known coronary venous vasculature that is inadequate for lead placement
* Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past month
* Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
* Patient has chronic (permanent) atrial arrhythmias
* Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
* Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
* Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
* Patient has a terminal illness and is not expected to survive more than three months
* Patient meets exclusion criteria required by local law (e.g. age, incompetence, pregnancy, breast feeding, etc).
* Patient is unable to tolerate an urgent thoracotomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01365234
Study Brief:
Protocol Section:
NCT01365234