2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy.
Michael Glikson, Jens Cosedis Nielsen, Mads Brix Kronborg...
https://pubmed.ncbi.nlm.nih.gov/34455430Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05327062
CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided by Non-Invasive Electrical and Venous Anatomy Assessment
Led by XSpline S.p.A. · Updated on 2024-10-24
150
Participants Needed
13
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a method to improve Cardiac Resynchronization Therapy (CRT) implantation by using a cloud-based pre-procedural roadmap. This roadmap integrates 3D images from electrical activation sequences and coronary venous anatomy obtained by non-invasive tests. The study aims to see if this approach can guide the placement of the left ventricular lead to areas of delayed electrical activation and reduce the heart's left ventricular end-systolic volume by at least 15% in 75% of patients six months after treatment. Participants will undergo CRT implantation guided by XSpline technology, which uses patient data including ECG, echocardiography, and computed tomography angiography. The imaging data are processed on a cloud platform to identify the best site for lead placement. The procedure follows local protocols with visual verification by X-ray to confirm lead position. The study includes at least 150 patients and compares the new approach's outcomes to previous CRT populations. During the study, participants will have their clinical and cardiovascular history recorded along with routine examinations and imaging tests. Researchers will monitor heart function changes, procedural time, and total X-ray exposure over six months. The main outcome measured is the reduction in left ventricular end-systolic volume. Safety and feasibility of the XSpline platform use for CRT implantation will also be assessed.
CONDITIONS
Brief Title
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent
- Age 18 years or older at time of consent
- Indication for CRT according to 2021 ESC or 2017 AHA/ACC/HFSA guidelines with class I or IIA indication and left bundle branch block
- Sinus rhythm
- QRS duration of 130 ms or more
- Left ventricular ejection fraction 35% or less
- Symptomatic heart failure NYHA class II or higher
- Stable medical treatment for at least 6 months
- No cardiovascular intervention within the last 6 months
You will not qualify if you...
- History of persistent or permanent atrial fibrillation
- Previous pacemaker or ICD implantation
- Indication for pacing due to bradycardia
- Planned His bundle pacing or cardiac conduction pacing
- Unstable angina
- Recent myocardial infarction within 40 days prior to enrollment
- Coronary artery bypass graft or valve surgery within 90 days prior to enrollment
- Post heart transplantation or listed for transplantation or likely to undergo transplantation within next year
- Implanted left ventricular assist device
- On continuous inotropic therapy for heart failure
- Severe aortic stenosis (valve area less than 1.0 cm2) or significant valve disease expected to be operated during study
- Congenital heart disease
- Mechanical right-sided heart valve
- Life expectancy less than one year per investigator
- Pregnant or breastfeeding women or women of childbearing potential not using reliable birth control
- Enrolled in other concurrent studies that may affect results
- Contraindications to CT scanning
- Chronic kidney disease with estimated glomerular filtration rate less than 40 ml/min/1.73m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of device implantation
Participants undergo CRT device implantation guided by a non-invasive electrical and venous anatomy assessment using the XSpline platform. This includes routine clinical workup, imaging, data processing, and lead placement according to local protocols.
1 visit (in-person)
Long-term Monitoring
Duration - 6 months
Participants are monitored for outcomes including reduction of left ventricular end-systolic volume and procedural parameters at 6 months after CRT implantation.
Follow-up visits over 6 months as per clinical protocol
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
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Research Team
C
Claudia M Amatruda, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
Noninvasive electrocardiographic imaging for cardiac electrophysiology and arrhythmia.
Charulatha Ramanathan, Raja N Ghanem, Ping Jia...
https://pubmed.ncbi.nlm.nih.gov/15034569Noninvasive reconstruction of cardiac electrical activity: update on current methods, applications and challenges.
M J M Cluitmans, R L M Peeters, R L Westra...
https://pubmed.ncbi.nlm.nih.gov/25896779Reconstruction of three-dimensional biventricular activation based on the 12-lead electrocardiogram via patient-specific modelling.
Simone Pezzuto, Frits W Prinzen, Mark Potse...
https://pubmed.ncbi.nlm.nih.gov/332414112013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA).
Michele Brignole, Angelo Auricchio, Gonzalo Baron-Esquivias...
https://pubmed.ncbi.nlm.nih.gov/23801822