RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-06
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05327062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Claudia M Amatruda, PhD
CONTACT
+390471200372
amatruda@xspline.com

Principal Investigator

Angelo Auricchio, MD PhD FESC
PRINCIPAL_INVESTIGATOR
Istituto Cardiocentro Ticino

Study Locations (Sites)

Rush University Medical center
Chicago, Illinois, 60637
United States
The University of Chicago Medicine
Chicago, Illinois, 60637
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Duke University Hospital
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: XSpline S.p.A.

  • Angelo Auricchio, MD PhD FESC, PRINCIPAL_INVESTIGATOR, Istituto Cardiocentro Ticino

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-06
Study Completion Date2025-09

Study Record Updates

Study Start Date2023-03-06
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Non-invasive activation mapping
  • Coronary Sinus

Additional Relevant MeSH Terms

  • Cardiac Resynchronization Therapy
  • Chronic Heart Failure
  • Left Bundle-Branch Block