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:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT01603706
Eligibility Criteria:
Inclusion Criteria:
* Patients with ischemic CMP based on evidence of prior MI by history, coronary angiography/revascularization or imaging
* AHA ACC or ESC EHRA Guideline-based indication (Class I or II) for CRT and NYHA class II-IV heart failure
* ECG wide QRS and :
QRS \> 120 msec in NYHA III- IV
OR
CLBBB or QRS \> 150 in NYHA =II
* Sinus rhythm predominant rhythm (PAF not an exclusion)
* All must be candidates for De novo CRT-D implantation with LV lead via transvenous approach or patients previously implanted with pacemaker or ICD with \<20% pacing over the last three months who are undergoing CRT-D upgrade.
* Patient provides informed consent, tolerate a pectoral implant, agree to comply with the protocol, and maintain scheduled follow-up visits.
Exclusion Criteria:
* Permanent or persistent atrial fibrillation
* Advanced renal disease (Cr \>=2.5 mg/dL)
* Advanced comorbidities with life expectancy of \<1 year
* Patients on waiting list for heart transplantation
* Requiring intravenous amines (continuous or or intermittent amine drip therapy)
* Severe chronic pulmonary disease (simulating heart failure)
* Severe (untreated) organic mitral valve disease
* Poorly treated hypertension
* History of myocardial infarction \< 3 months; unstable angina \< 1m, CABG \<3 months; PCI \<3 months
* Mechanical TC valve
* Previously implanted CRT system
* Poorly visualized cardiac chamber dimensions in an echocardiogram performed prior to enrollment - please help us define
* Pregnancy or child-bearing potential in the absence of accepted forms of birth control
* Concurrent enrollment in other study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01603706
Study Brief:
Protocol Section:
NCT01603706