Heart Disease Trial, Recruiting NCT06543173 Sponsor: University of Rochester Condition: Heart Disease
Back to Heart Disease

Heart Disease Trial, Recruiting

NCT06543173
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:

  • You are 18 years of age or older (there is no upper age limit)
  • You are willing and able to give your informed agreement to take part in the study
  • Your doctor has recommended you as a candidate for a type of heart device (ICD or CRT-D) to help prevent a serious heart event before one occurs
  • You have heart disease caused by blocked or narrowed arteries (ischemic cardiomyopathy), and your heart's pumping strength is 35% or less
  • You are willing and able to receive a heart device (ICD)
  • You are willing and able to have a catheter-based procedure to treat abnormal heart rhythms (VT ablation)
  • You meet at least one of the following: a risk score called the MADIT-ICD Benefit Score above 75 (confirm with trial site), a history of short episodes of fast abnormal heart rhythm that stop on their own, or a high number of extra heartbeats (10% or more of your heartbeats are irregular)

Who may not be able to join:

  • You already have an ICD or CRT-D heart device implanted
  • You have a history of sustained dangerous heart rhythm episodes (sustained VT or VF)
  • You have severe kidney disease that requires regular dialysis
  • You have had a procedure to open or bypass blocked heart arteries within the last 3 months
  • You have had a certain type of serious heart attack (ST-elevation MI) within the last 3 months
  • You are currently taking part in another clinical trial, unless the team running this study has given specific approval
  • You are currently pregnant or planning to become pregnant in the near future
  • You are unable or unwilling to follow the study's requirements and schedule
  • You are unable or unwilling to give your informed agreement to take part
  • Your doctors estimate you are not expected to live for more than one year

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 16 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

Phone: 585-275-5391

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
Registry
ClinicalTrials.gov
Start date
22 January 2026
Est. completion
1 August 2030

Where this trial is recruiting

🇩🇰 Denmark 🇫🇷 France 🇪🇸 Spain

Primary endpoints

Total Number of VT Arrhythmia Events in High-Risk Patients with Ischemic Cardiomyopathy (ICM) After Primary ICD Implantation: Comparison of Preventive Catheter-Based VT Ablation Versus Medical Management.

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: 16 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