Could a diaphragm pacemaker help failing hearts?

NCT ID NCT06552637

Recruiting now Disease control Sponsor: VisCardia Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests a device that stimulates the diaphragm in time with the heartbeat to help people with heart failure. Researchers will see if it improves heart function, exercise ability, and quality of life. About 270 participants will receive the device plus standard care, or standard care alone.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Synchronized Diaphragmatic Stimulation device (VisONE System)
What this could lead to: If it works, this could offer a new treatment option for people with heart failure, potentially improving heart function, exercise ability, and quality of life.
What could go wrong: This is an early-stage trial with 270 participants, so results may not apply to everyone. The device requires surgery and carries risks like infection, breathing problems, or heart complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

heart disorder heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEART FAILURE WITH REDUCED EJECTION FRACTION

Contacts and locations

Locations

Saint Francis Hospital
RECRUITING

Tulsa, Oklahoma, 74136, United States
Tbilisi Heart and Vascular Clinic
RECRUITING

Tbilisi, 0159, Georgia
University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States

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