CRT-DRIVE: Cardiac Resynchronization Therapy DeliveRy guided by non-Invasive electrical and VEnous anatomy assessment
- Conditions
- Symptomatic heart failure10019280
- Registration Number
- NL-OMON56818
- Lead Sponsor
- XSpline S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
• Informed Consent signed by the subject
• Age >=18 years at time of consent.
• CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT
(class I and
IIA indication in patients with LBBB QRS morphology) or to 2017 AHA/ACC/HFSA
guidelines
(COR I).
• Patients in Sinus Rhythm, who are scheduled for CRT device implantation in
less than 3
months.
• QRS duration >=130 ms
• Left bundle branch block
• Left ventricular ejection fraction <=35%
• Symptomatic heart failure NYHA class >= II
• Documented stable medical treatment for at least 6 months
• No cardiovascular intervention during the last 6 months
• History of persistent or permanent atrial fibrillation • Previous pacemaker
or ICD implantation • Indication to pacing due to bradycardia • Patients
considered for His bundle pacing or cardiac conduction pacing • Patients with
unstable angina • Subject experienced a recent myocardial infarction, within 40
days prior to enrollment • Subject underwent coronary artery bypass graft or
valve surgery, within 90 days prior to enrollment • Subject is post heart
transplantation, or is actively listed on the transplantation list, or has
reasonable probability (per investigator*s discretion) of undergoing
transplantation in the next year • Subject is implanted with a left ventricular
assist device • Subject is on continuous or uninterrupted infusion (inotropic)
therapy for heart failure • Subject has severe aortic stenosis (with a valve
area of <1.0 cm2 or significant valve disease expected to be operated within
study period) • Subject has congenital heart disease • Subject has a mechanical
right-sided heart valve • Subject has a life expectancy of less than one year
in the opinion of the investigator • Pregnant or breastfeeding women, or women
of child bearing potential and who are not on a reliable form of birth control
• Subject is enrolled in one or more concurrent studies that would confound the
results of this study • Patients who have contraindications to CT scanning. •
Patients with chronic kidney diseases and estimated glomerular filtration rate
(eGMR) calculated based on CKD-EPI 2009 < 40 ml/min/1.73m2 • Patients with
diseases of the thyroid gland with impaired T3 and T4 levels
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method