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Heart Failure With Reduced Ejection FractionNCT05592392

RECOVER-HF Pilot Study of SDS in Heart Failure

A study testing Synchronized Diaphragmatic Stimulation in people with Heart Failure With Reduced Ejection Fraction, run by VisCardia Inc. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Synchronized Diaphragmatic Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
2 sitesin 2 countries
Study dates
23 Aug 2022to 28 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Serum creatinine > 2.5 mg/dL
  • Serum hepatic function 3x ULN
Show all 26Show fewer
  • Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT or DCCV within 3 months
  • Intermittent IV inotropic drug treatment
  • 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
  • Reversible non-ischemic cardiomyopathy
  • 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
  • Diabetic neuropathy
  • Existing diaphragmatic stimulation for respiration assist
  • LVAD or other mechanical cardiac assist devices
  • 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.
  • Previous open laparotomy within 1 year
  • Previous thoracic or abdominal organ transplant
  • Drug induced immuno-suppression
  • Body mass index > 40
  • Enrollment in a concurrent investigation / clinical study
  • Having a life expectancy of <1 year due to any condition
  • Pregnant or planning a pregnancy during the study period

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Georgia1 site

  • Tbilisi Heart And Vascular Clinic

    Tbilisi, 0159

Other trials in Georgia

Uzbekistan1 site

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

    Tashkent, 100115

Other trials in Uzbekistan

About this study

Official title: RECOVER-HF Pilot Study - Randomized, Single-Center, Double-blinded Study of Synchronized Diaphragmatic Stimulation (SDS) for Improvement of Symptomatic Reduced Ejection Fraction Heart Failure

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.

Read the detailed description

Symptomatic Diaphragmatic Stimulation (SDS) is a novel approach designed to improve cardiac function, symptoms, and, ultimately, outcomes for patients who are symptomatic for heart failure.

Elevated intracardiac pressures are the hallmark of heart failure (HF) and a key pathological driver of disease progression and limited exertional capacity. The degree of cardiac pressure elevation is determined by preload, afterload, and pericardial restraint. The pericardium restrains the heart, and the degree of restraint is determined by the pericardial structure itself and the intrathoracic pressure. This aspect of HF pathophysiology is among the fundamental drivers behind the SDS therapy concept. SDS induces a temporal modulation of intrathoracic pressure with a resultant reduction in pericardial restraint, leading to improved cardiac filling and reduced afterload. When applied at the right time in the cardiac cycle, SDS can improve cardiac filling, cardiovascular pressure conditions, and systolic cardiac performance.

Encouraged by the results of the VisONE HF study pilot (NCT03484780), SDS shall now be further valuated in a randomized controlled trial (RCT) pilot. This RCT pilot has three objectives: two semi-acute items (15-30 days) verification of sensing function using the modified input filters and improved usability based on increased automaticity of the user-interface; and one chronic result (6 months) to reproduce similar efficacy endpoints. The herein described study is a pilot trial for a larger RCT trial.

Being tested
Synchronized Diaphragmatic Stimulation
Keywords
Heart Failure, Heart Disease, Cardiovascular Diseases, Synchronized Diaphragmatic Stimulation, Implantable Heart Failure Device Therapy
Medical subject headings
Heart Failure, Heart Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synchronized Diaphragmatic StimulationDevice

    Also called ADS, SDS, VisONE SDS

    Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.

Study groups in NCT05592392
Study groupRoleWhat they receive
TherapyExperimentalSDS system implanted and Therapy On for 6 months post randomization
Receives: Device: Synchronized Diaphragmatic Stimulation
ControlSham comparatorSDS system implanted and Therapy Off for 6 months post randomization
Receives: Device: Synchronized Diaphragmatic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in LVESV

    Change from baseline in left ventricular end systolic volume (LVESV) post-randomization between the control group and the therapy group.

    Measured: 6 months

  2. Freedom from VisONE device-related and procedure-related Major Adverse Respiratory and Cardiovascular Events (MARCE) after the index implantation procedure

    The following Major Respiratory and Cardiovascular Events will be analyzed for their rate and severity and association with the implantable device or procedure:

    1. CV Death
    2. Stroke
    3. Cardiac Arrest
    4. Interaction with cardiac rhythm device requiring permanent termination of SDS therapy
    5. Acute Heart Failure Decompensation
    6. Infection requiring device/lead explant
    7. Diaphragmatic dysfunction leading to a clinically significant reduction is respiratory function
    8. Inadequate SDS therapy delivery requiring surgical intervention
    9. Injury to abdominal organs requiring surgical intervention
    10. Pneumothorax
    11. Hemothorax
    12. Peritonitis

    Measured: 12 months

Secondary outcomes (2)

  1. Change in 6MHW distance

    Change from baseline in 6 MHW distance post-randomization between the control group and the therapy group.

    Measured: 6 months

  2. Change in MLWHF overall score

    Change from baseline in MLWHF total score post-randomization between the control group and the therapy group.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2022
  2. Study start23 Aug 2022
  3. Primary completion30 Sep 2024
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Partial crossover - initial randomized to therapy On/Off. Subsequent OFF converted to On after primary efficacy endpoint.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05592392
Sponsor's protocol ID
VisCardia H02_22
Status last verified
Sep 2025
First submitted
19 Oct 2022
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Synchronized Diaphragmatic Stimulation in people with Heart Failure With Reduced Ejection Fraction, run by VisCardia Inc. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Georgia, Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in LVESV (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05592392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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