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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01172067
Eligibility Criteria:
Inclusion Criteria:
* • Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system
* Patient is able to provide written informed consent for study participation
Exclusion Criteria:
* • Patient has limited intrinsic atrial activity (≤ 40 bpm)
* Patient has persistent or permanent AF
* Patient has a 2o or 3o heart block
* Patient's life expectancy is \<12 months
* Patient is \<18 years old
* Patient is pregnant
* Patient is on IV inotropic agents
* Patients who are ongoing other devices or agents study
* Patients with heart transplanted or waiting for heart transplant
* Patients with Hypertrophic and obstructive cardiomyopathy
* Patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01172067
Study Brief:
Protocol Section:
NCT01172067