Guided implantation of cardiac resynchronization therapy using non-invasive assessment
CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
This study is testing a new way to place a heart device for people with heart failure to see if it can help them feel better by improving heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | XSpline S.p.A. Industry-sponsored |
| Locations | 13 sites (Chicago, Illinois and 12 other locations) |
| Trial ID | NCT05327062 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a personalized approach to cardiac resynchronization therapy (CRT) implantation by utilizing a cloud-based roadmap that integrates 3D images from ECG activation sequences and coronary venous anatomy from cardiac CT scans. The roadmap will guide the placement of the left ventricular lead in areas of the heart that are electrically delayed. The hypothesis is that at least 75% of patients will experience a significant reduction in left ventricular end-systolic volume after the procedure, assessed at six months post-implantation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with left bundle branch block and symptomatic heart failure who meet specific clinical guidelines for CRT.
Not a fit: Patients with a history of persistent atrial fibrillation or those who have previously undergone pacemaker or ICD implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes for patients with chronic heart failure by optimizing CRT lead placement.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving CRT outcomes through advanced imaging techniques.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 12 other locations
- Rush University Medical center — Chicago, Illinois, United States (Not_yet_recruiting)
- The University of Chicago Medicine — Chicago, Illinois, United States (Not_yet_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Duke University Hospital — Durham, North Carolina, United States (Recruiting)
- Ordensklinikum Linz Elisabethinen Hospital — Linz, Austria (Recruiting)
- Semmelweis University — Budapest, Hungary (Not_yet_recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Pavia, Italy (Not_yet_recruiting)
- University Tor Vergata — Roma, Roma, Italy (Not_yet_recruiting)
- General Hospital of Bolzano — Bolzano, Italy (Not_yet_recruiting)
- Ospedale S. Maria del Carmine di Rovereto — Rovereto, Italy (Not_yet_recruiting)
- Maastricht University Medical Center — Maastricht, Netherlands (Not_yet_recruiting)
- Univeristat de Barcelona — Barcelona, Spain (Recruiting)
- Istituto Cardiocentro Ticino — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Angelo Auricchio, MD PhD FESC — Istituto Cardiocentro Ticino
- Study coordinator: Claudia M Amatruda, PhD
- Email: amatruda@xspline.com
- Phone: +390471200372
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.