Cardiomyopathy Trial, Recruiting NCT04504188 Sponsor: Zoll Medical Corporation Condition: Cardiomyopathy
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Cardiomyopathy Trial, Recruiting

NCT04504188
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 a woman who has recently been diagnosed with a weakened heart (either caused by blocked arteries or another reason), and your heart's pumping ability is at or below 35% at the time you are given a wearable heart device (WCD).
  • You have been prescribed the wearable heart device with a plan to wear it for about 90 days (anywhere from 76 to 104 days).
  • You have been wearing the wearable heart device for no more than 14 days since you agreed to join the study.
  • You have not been hospitalised for heart failure in the 30 days before joining the study.
  • You are 18 years of age or older at the time you agree to take part.
  • To continue into the second phase of the trial, you must have been actively wearing the device for at least 15 hours per day (105 hours per week) during the first two weeks.

Who may not be able to join:

  • You cannot tolerate or have a medical reason to avoid a type of heart medication called beta-blockers.
  • You have a permanent irregular heart rhythm known as atrial fibrillation.
  • You have a pacemaker.
  • You currently have, or have previously had, an implanted heart device designed to correct dangerous heart rhythms (an ICD).
  • You are pregnant (based on self-report).
  • You have a heart condition that you were born with or that runs in your family.
  • You are already taking part in another clinical trial that involves a treatment or device.
  • You are not expected to live longer than 3 months.
  • You stopped wearing the wearable heart device within the first two weeks (this would prevent you from continuing into the second phase).

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 28 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: Valentina Kutyifa, MD PHD, University of Rochester

Phone: 412-968-3333

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
Zoll Medical Corporation
Registry
ClinicalTrials.gov
Start date
8 March 2021
Est. completion
1 September 2024

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Heart Rate Control

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: 28 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