Could a diaphragm pacemaker help failing hearts?

NCT ID NCT05592392

Completed Disease control Sponsor: VisCardia Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This pilot study tested a device that stimulates the diaphragm in time with the heartbeat to see if it can improve heart function in people with heart failure. 35 participants with reduced ejection fraction received the implant. The study checked for safety and changes in heart size and exercise ability.

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 (SDS) device
What this could lead to: If it works, this could offer a new way to improve heart function and quality of life for people with heart failure.
What could go wrong: This is a small, early feasibility study with only 35 participants. The device requires surgery and carries risks like infection or breathing problems. Results may not apply to all heart failure patients.

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.

cardiovascular disorder 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

Republican Specialized Scientific and Practical Medical Center for Surgery n.a. V. Vakhidov

Tashkent, 100115, Uzbekistan
Tbilisi Heart And Vascular Clinic

Tbilisi, 0159, Georgia

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