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NCT05327062 · ClinicalTrials.gov registry record · NA

Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment

A NA study of Chronic Heart Failure and Cardiac Resynchronization Therapy, sponsored by XSpline S.p.A..

Recruiting
Registry status
NA
Development phase
150
Enrollment target
13
Study locations

NCT05327062 is a NA study of Chronic Heart Failure and Cardiac Resynchronization Therapy that is actively recruiting participants, run by XSpline S.p.A.. The registered enrollment target is 150 participants, below the 410-participant average among 12 other Chronic Heart Failure trials with a reported enrollment target (63% lower). The trial reports 13 study locations across 6 states.

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The verdict

NCT05327062, a NA study of Chronic Heart Failure and Cardiac Resynchronization Therapy, is actively recruiting participants, sponsored by XSpline S.p.A..

RECRUITING
Registry status
NA
Development phase
150 participants
Enrollment target
13
Study locations

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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2023-03-06
Est. Completion 2025-09
Phase NA

Sponsor

XSpline S.p.A.

1 total trials

What the Registry Record Tells You About NCT05327062

The ClinicalTrials.gov registry entry for NCT05327062 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 410-participant average among 12 other Chronic Heart Failure trials with a reported enrollment target (63% lower). The listed sponsor is XSpline S.p.A., which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT05327062 reports 13 study locations spanning 6 distinct geographic areas - top geographies include Other, Illinois, Massachusetts.

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.

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).

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.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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