Actively Recruiting
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Led by XSpline S.p.A. · Updated on 2024-10-24
150
Participants Needed
13
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from 3D activation sequence from ECG, and coronary venous anatomy from cardiac computed tomography. This CRT-roadmap will be used to guide LV lead placement to a coronary vein in an electrically late-activated region. Study Hypothesis: At least 75% of patients undergoing a CRT implantation guided by non-invasive electrical and venous anatomy assessment (XSPLINE technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.
CONDITIONS
Official Title
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent is provided.
- Age 18 years or older at time of consent.
- Indication for CRT based on 2021 ESC guidelines (class I and IIA for LBBB) or 2017 AHA/ACC/HFSA guidelines (class I).
- Sinus rhythm (normal heart rhythm).
- QRS duration of 130 milliseconds or more.
- Presence of left bundle branch block.
- Left ventricular ejection fraction of 35% or less.
- Symptomatic heart failure classified as NYHA class II or higher.
- Stable medical treatment for heart failure for at least 6 months.
- No cardiovascular interventions within the last 6 months.
You will not qualify if you...
- History of persistent or permanent atrial fibrillation.
- Previous pacemaker or implantable cardioverter defibrillator (ICD) implantation.
- Pacing indicated due to bradycardia.
- Candidates for His bundle pacing or cardiac conduction pacing.
- Unstable angina.
- Recent myocardial infarction within 40 days before enrollment.
- Coronary artery bypass graft or valve surgery within 90 days prior to enrollment.
- Post heart transplantation, actively listed for transplantation, or likely to undergo transplantation within one year.
- Implanted with a left ventricular assist device.
- Receiving continuous inotropic therapy for heart failure.
- Severe aortic stenosis (valve area less than 1.0 cm2) or significant valve disease expected to require surgery during the study.
- Congenital heart disease.
- Mechanical right-sided heart valve.
- Life expectancy less than one year as judged by investigator.
- Pregnant or breastfeeding women, or women of childbearing potential not using reliable contraception.
- Participation in other studies that could affect results.
- Contraindications to CT scanning.
- Chronic kidney disease with estimated glomerular filtration rate below 40 ml/min/1.73m2.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Rush University Medical center
Chicago, Illinois, United States, 60637
Not Yet Recruiting
2
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
Not Yet Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
5
Ordensklinikum Linz Elisabethinen Hospital
Linz, Austria
Actively Recruiting
6
Semmelweis University
Budapest, Hungary
Not Yet Recruiting
7
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy
Not Yet Recruiting
8
University Tor Vergata
Roma, Roma, Italy
Not Yet Recruiting
9
General Hospital of Bolzano
Bolzano, Italy
Not Yet Recruiting
10
Ospedale S. Maria del Carmine di Rovereto
Rovereto, Italy
Not Yet Recruiting
11
Maastricht University Medical Center
Maastricht, Netherlands
Not Yet Recruiting
12
Univeristat de Barcelona
Barcelona, Spain
Actively Recruiting
13
Istituto Cardiocentro Ticino
Lugano, Switzerland
Actively Recruiting
Research Team
C
Claudia M Amatruda, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here