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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT04763460
Eligibility Criteria:
Inclusion Criteria:
1. Currently on standard medical therapy
2. CRT device in place for \> 4 months
3. Non-responder (ejection fraction improvement with CRT \< 5%) or incomplete responder (ejection fraction \< 40%)
4. Suboptimal electrical wavefront fusion at current CRT programming as observed on 12-lead ECG
5. Left bundle branch block, interventricular conduction delay or right ventricular paced underlying QRS complex
6. Age \> 18 years
Exclusion Criteria:
1. Decompensated heart failure
2. Right bundle branch block
3. Pregnancy or lactation
4. History of severe allergic reactions to ECG gels, electrode adhesives, and/or cardiac magnetic resonance contrast (e.g. gadolinium)
5. Implantation of pacing lead in the his bundle or left bundle branch
6. Frequent ventricular ectopy as defined as \>10% premature ventricular contraction burden by either device interrogation or Holter monitor, or sustained ventricular tachycardia/ventricular fibrillation
7. Uncontrolled atrial fibrillation (HR \> 100 bpm)
8. Patient is enrolled in concurrent research study that would potentially confound the results of this study (noting: co-enrollment acceptable if patient is enrolled in registry study)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04763460
Study Brief:
Protocol Section:
NCT04763460