Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVisCardia Inc.
About this trial
RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.
Eligibility criteria
Qualifiers
NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT)
QRS duration ≤ 130 ms
EF≤ 40%
Disqualifiers
Baseline 6 minute walk test > 500 meters or < 200 meters
NT-proBNP< 250 if on loop diuretics, or NT-proBNP < 500 if not on loop diuretics
Supine resting heart rate > 140 bpm
Systolic blood pressure < 80 mmHg or > 170 mmHg
Trial design
Treatments tested in this trial
- Synchronized Diaphragmatic Stimulation
Treatment groups
270 Participants
are divided into 2 treatment groupsSponsors and collaborators
VisCardia Inc.
Lead sponsor
Clinical Accelerator
Collaborator
Duke Clinical Research Institute
Collaborator
Source ClinicalTrials.gov