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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT03495505
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18
* Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
* Patients with pre-existing permanent pacing systems in situ.
* Left ventricular systolic impairment with ejection fraction of \<45%
* Clinical symptoms of heart failure despite optimal medical therapy (NYHA II- IV)
* QRS duration \>120ms on surface ECG
Exclusion Criteria:
* Creatinine clearance \<30mls/minute (GFR)
* Severe allergy to contrast medium or severe asthma/ COPD
* Life expectancy \<1 year
* Significant aortic valve disease or prosthesis
* Significant mitral regurgitation
* Significant peripheral vascular disease
* Contraindication to anticoagulation therapy
* Insufficient acoustic window to the LV as assessed from diagnostic transthoracic echocardiography
* Left atrial or ventricular thrombus
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03495505
Study Brief:
Protocol Section:
NCT03495505