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Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
NCT05327062 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DEVICE CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
Study Locations (13)
Other
- Ordensklinikum Linz Elisabethinen Hospital — Linz
- Semmelweis University — Budapest
- General Hospital of Bolzano — Bolzano
- Ospedale S. Maria del Carmine di Rovereto — Rovereto
- Maastricht University Medical Center — Maastricht
- Univeristat de Barcelona — Barcelona
- Istituto Cardiocentro Ticino — Lugano
Illinois
- Rush University Medical center — Chicago
- The University of Chicago Medicine — Chicago
Massachusetts
- Massachusetts General Hospital — Boston
North Carolina
- Duke University Hospital — Durham
Pavia
- Fondazione IRCCS Policlinico San Matteo — Pavia
Roma
- University Tor Vergata — Roma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-03-06 |
| Est. Completion | 2025-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05327062
The ClinicalTrials.gov registry entry for NCT05327062 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is XSpline S.p.A., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Chronic Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05327062 reports 13 study locations spanning 6 distinct geographic areas — top geographies include Other, Illinois, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05327062 about?
NCT05327062 is a clinical study titled "Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment". 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 cardia...
What is the current status of trial NCT05327062?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2023-03-06. Estimated completion is 2025-09.
What conditions does trial NCT05327062 study?
This clinical trial studies the following conditions: Chronic Heart Failure, Cardiac Resynchronization Therapy, Left Bundle-Branch Block. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05327062?
The interventions under investigation include: CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05327062?
This trial is sponsored by XSpline S.p.A., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05327062 being conducted?
This trial has 13 study locations across Illinois, Massachusetts, North Carolina, Pavia, Roma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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