Heart Disease Trial, Recruiting NCT05327062 Sponsor: XSpline S.p.A. Condition: Heart Disease
Back to Heart Disease

Heart Disease Trial, Recruiting

NCT05327062
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to give signed and dated consent to take part in the trial
  • People who are 18 years of age or older at the time of giving consent
  • People whose heart condition meets the guidelines for a treatment called cardiac resynchronisation therapy (CRT), based on specific international cardiology guidelines (confirm with trial site)
  • People who have a normal, steady heart rhythm (called sinus rhythm)
  • People whose heart's electrical signal takes 130 milliseconds or longer to travel through the heart (a measure called QRS duration)
  • People who have a specific heart electrical problem called left bundle branch block
  • People whose heart pumps out 35% or less of its blood with each beat (a measure called left ventricular ejection fraction)
  • People with heart failure symptoms that are at least moderately limiting to daily life (classified as NYHA Class II or higher)
  • People who have been on a stable heart medication plan for at least 6 months
  • People who have not had any heart-related procedures or surgeries in the last 6 months

Who may not be able to join:

  • People with a history of long-lasting or permanent irregular heart rhythm in the upper chambers of the heart (atrial fibrillation)
  • People who already have a pacemaker or an implanted heart defibrillator (ICD)
  • People who need a pacemaker because their heart beats too slowly
  • People whose doctors are considering a specific type of pacemaker placement involving the heart's natural electrical pathway (His bundle or cardiac conduction pacing)
  • People who have unstable chest pain (unstable angina)
  • People who have had a heart attack within the last 40 days before joining the trial
  • People who have had open-heart bypass surgery or heart valve surgery within the last 90 days before joining the trial
  • People who have already had a heart transplant, are currently on a waiting list for one, or are likely to need one within the next year
  • People who have a mechanical device already implanted to help the left side of their heart pump (a left ventricular assist device)
  • People who are currently receiving continuous drip-based medication through a drip to help their heart pump
  • People with severe narrowing of the heart's aortic valve (valve opening less than 1.0 cm², or valve surgery expected during the study period)
  • People born with a structural heart defect (congenital heart disease)
  • People who have an artificial mechanical valve on the right side of their heart
  • People whose treating doctor believes they have less than one year to live
  • Women who are pregnant, breastfeeding, or of childbearing age and not using a reliable form of contraception
  • People who are already participating in another clinical study that could affect the results of this trial
  • People who are unable to have a CT scan for medical reasons
  • People with chronic kidney disease where a specific kidney function measure (eGFR, calculated using a standard formula) is below 40 ml/min/1.73m²

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Angelo Auricchio, MD PhD FESC, Istituto Cardiocentro Ticino

Phone: +390471200372

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
XSpline S.p.A.
Registry
ClinicalTrials.gov
Start date
6 March 2023
Est. completion
1 March 2025

Where this trial is recruiting

🇦🇹 Austria 🇭🇺 Hungary 🇮🇹 Italy 🇳🇱 Netherlands 🇪🇸 Spain 🇨🇭 Switzerland 🇺🇸 United States

Primary endpoints

Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov