Guided CRT Implantation for Chronic Heart Failure
(CRT-DRIVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve heart device placement using a personalized plan created from advanced 3D images. It targets patients who need precise heart treatment. The detailed images help doctors place the device in the best spot to improve heart function. This therapy has emerged as an established treatment for patients with severe heart conditions and symptoms that do not respond to standard medication.
Will I have to stop taking my current medications?
The trial requires that participants have been on stable medical treatment for at least 6 months, so you will not need to stop your current medications if they have been stable.
Is guided CRT implantation generally safe for humans?
Implanting cardiac resynchronization devices like CRT-P and CRT-D is generally safe, but there are rare complications that can occur during the procedure. Studies have shown that these devices are used to manage heart failure, and while they can reduce hospital readmissions, there are some risks involved with the implantation process.12345
How is the Guided CRT Implantation treatment for chronic heart failure different from other treatments?
Guided CRT Implantation is unique because it uses advanced techniques like electromagnetic navigation and 3-D mapping to precisely place the device, reducing x-ray exposure and targeting the most delayed heart regions for optimal response. This approach aims to improve the effectiveness of the treatment compared to traditional methods.12678
What data supports the effectiveness of the treatment XSpline, CRT, CRT-P, CRT-D, Biventricular Pacemaker, Cardiac Resynchronization Device for chronic heart failure?
Research shows that cardiac resynchronization therapy (CRT) can improve symptoms and survival in patients with heart failure and specific heart rhythm issues. Studies also highlight the importance of choosing between a CRT pacemaker (CRT-P) and a CRT with defibrillator (CRT-D) based on individual patient needs, as both have shown benefits in managing heart failure.268910
Who Is on the Research Team?
Angelo Auricchio, MD PhD FESC
Principal Investigator
Istituto Cardiocentro Ticino
Are You a Good Fit for This Trial?
This trial is for adults over 18 with chronic heart failure, left bundle branch block (LBBB), and a specific type of heart rhythm issue. They must have symptoms of heart failure despite stable treatment for 6 months and not be pregnant or at risk of pregnancy without contraception. Exclusions include recent heart attacks, certain surgeries, severe kidney disease, other major cardiac conditions, or participation in conflicting studies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-procedural Planning
Creation of a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from ECG and coronary venous anatomy from cardiac computed tomography
CRT Implantation
CRT implantation guided by non-invasive electrical and venous anatomy assessment using XSPLINE technology
Follow-up
Participants are monitored for safety and effectiveness after CRT implantation, with a focus on reduction of left ventricular end-systolic volume
What Are the Treatments Tested in This Trial?
Interventions
- XSpline
XSpline is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
XSpline S.p.A.
Lead Sponsor