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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT03573427
Eligibility Criteria:
Inclusion Criteria:
* Patients with NYHA Class II-IV ambulatory HF symptoms
* Optimal HF Medical Therapy of at least 3 months (2009 ACCF/AHA, ESC 2012)
* LVEF less than or equal to 35%
* Sinus rhythm (can have paroxysmal atrial fibrillation)
* QRS morphology is non-RBBB
* QRS duration 120-149 ms
* Patients with pacemaker or ICD that meet the above criteria may be upgraded to CRT-D or CRT-P
* Patients are able to receive oral anticoagulation
Exclusion Criteria:
* Patients with atrial septal defect closure
* Planned atrial fibrillation ablation within 12 months
* Patients with mitral prosthetic valve that precludes the placement of an LV lead trans-septally
* Patients with RBBB
* Patients with intra-cardiac thrombi
* Patients with permanent atrial fibrillation
* Patients with contraindications to oral anti-coagulation
* In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
* Acute coronary syndrome (including MI) \< 4 weeks
* Coronary revascularization (CABG or PCI) \< 3 months
* Uncorrected or uncorrectable primary valvular disease
* Restrictive, hypertrophic or reversible form of cardiomyopathy
* Severe primary pulmonary disease such as cor pulmonale
* Patients with a life expectancy of less than one year from non-cardiac cause.
* Patients included in other clinical trials that will affect the objectives of this study
* Those unable or unwilling to provide informed consent
* Those with a history of noncompliance to medical therapy
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03573427
Study Brief:
Protocol Section:
NCT03573427