NCT05592392Completed
RECOVER-HF Pilot Study of SDS in Heart Failure
RECOVER-HF Pilot Study - Randomized, Single-Center, Double-blinded Study of Synchronized Diaphragmatic Stimulation (SDS) for Improvement of Symptomatic Reduced Ejection Fraction Heart Failure
Source: ClinicalTrials.gov · Last updated 22 Sept 2025
Brief summary (registry, in English)
The RECOVER HF pilot is a feasibility study for evaluating a randomized, doubled-blinded study design to determine the benefits and risks of chronically delivering Synchronized Diaphragmatic Stimulation (SDS) in Heart Failure patients on GDMT with NYHA II/III, EF\<=40% and QRSd,=130ms.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 19 Oct 2022
- Start date
- 23 Aug 2022
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- VisCardia Inc.
- Diseases
- Heart failure
- NCT number
- NCT05592392
What you commit to
- Study type: Interventional
- Participants enrolled: 35
- From 23 Aug 2022 to the primary completion date, 30 Sept 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intermittent IV inotropic drug treatment
- Previous open laparotomy within 1 year
- Previous thoracic or abdominal organ transplant
- Drug induced immuno-suppression
- Enrollment in a concurrent investigation / clinical study
Other illness
- Supine resting heart rate \> 140 bpm
- Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT or DCCV within 3 months
- Arrhythmias present during screening (profound ectopy, bradycardia, profound prevalence of ectopy, NSVT, VF, AF\*, SVT or AFLT) - \* see enrollment exception allowing for 10 patients in AF for a separate subgroup analysis
- Primary valvular disease
- Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys \>70 mmHg at rest
- Severe COPD, other respiratory or lung diseases where FEV \< 50%
- Pericardial disease
- LVAD or other mechanical cardiac assist devices
- Having a life expectancy of \<1 year due to any condition
Lab values
- Serum creatinine \> 2.5 mg/dL
- Serum hepatic function 3x ULN
Other
- 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
- Systolic blood pressure \< 80 mmHg or \> 170 mmHg
- Reversible non-ischemic cardiomyopathy
- Diabetic neuropathy
- Existing diaphragmatic stimulation for respiration assist
- Contraindications to laparoscopic access to the diaphragm, as determined by the implanting physician
- Known intra-abdominal pathology which could increase the risk of laparoscopic access to the diaphragm.
- Body mass index \> 40
- Pregnant or planning a pregnancy during the study period
Who the study is looking for
- NYHA classes II/III on optimal Guideline Directed Medical Therapy
- QRS duration ≤ 130 ms
- LVEF \< 40%
- Willing and able to comply with protocol requirements, including attending all required visits
- Wiling to participate in the study and able to sign an informed consent form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tbilisi Heart and Vascular Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Republican Specialized Scientific and Practical Medical Center for Surgery n.a. V. Vakhidov Coordinator of this site? Confirm its status | Tashkent | Uzbekistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.