Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment

Launched by XSPLINE S.P.A. · Apr 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to improve a treatment called Cardiac Resynchronization Therapy (CRT) for patients with chronic heart failure and a specific type of heart condition known as left bundle branch block. The trial aims to see if using advanced imaging technology can help doctors create a personalized plan for where to place the leads in the heart. This plan is based on a combination of 3D heart images and electrical activity data, which will hopefully lead to better outcomes for patients. The goal is for at least 75% of participants to show a significant improvement in heart function within six months after the procedure.

To be eligible for this trial, participants should be at least 18 years old, have been diagnosed with heart failure, and meet specific medical criteria outlined by health guidelines. They should not have certain heart conditions, recent surgeries, or other serious health issues that could complicate the study. Those who join the trial can expect to undergo imaging tests and then receive the CRT procedure based on the detailed plan created from their results. It's important to note that participants will be actively monitored throughout the trial to assess their progress and ensure their safety.

Gender

ALL

Eligibility criteria

• Eligible subjects shall meet all following criteria:
• • Appropriately signed and dated informed consent.
• • 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).
• • Sinus rhythm
• • 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 month
• Exclusion Criteria are:
• • 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