Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Chronic Heart Failure and Cardiac Resynchronization Therapy, sponsored by XSpline S.p.A..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Increase in efficacy of CRT using XSpline technology assessed by reduction of left ventricular end-systolic volume of at least 15% at 6-month follow-up in 75% of CRT treated patients, based on routine echo-cardiographic measurements
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 |
What NCT05327062 shows while recruiting
NCT05327062 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 410-participant average among 12 other Chronic Heart Failure trials with a reported enrollment target (63% lower).
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 lists 13 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Chronic Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05327062's enrollment target sits among peer trials
150 7th of 12 higher than 6 of 12 other Chronic Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
RECRUITING · NA
-
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
RECRUITING · NA
-
The HEARTFELT Study
RECRUITING · NA
-
Cost and Shared Decision-Making for Heart Failure
COMPLETED · NA
-
Telehealth Management in HF Disparity Patients
COMPLETED · NA
-
Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI