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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT03189368
Eligibility Criteria:
Inclusion Criteria:
* Adult (\>18 years of age), consenting patients
* Any cardiomyopathy type and
* An existing I/IIa indication for a CRT-D device
Exclusion Criteria:
* Those with a class IIb CRT indication
* Those where thresholds of \<3.5V@0.5msec cannot be achieved in at least two dipoles of the left pacing electrode
* Those where no dipole with a distance between poles of 30mm can be detected
* Those with \>2/4 (moderate to severe - severe) mitral/aortic insufficiency, rendering noninvasive VAC calculation unreliable.
* Finally, contraindication to receiving intravenous paramagnetic contrast (gadolinium) will also constitute grounds for exclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03189368
Study Brief:
Protocol Section:
NCT03189368