RECOVER-HF Pilot Study of SDS in Heart Failure

NCT05592392 | Completed DMC

• 1 other identifier: VisCardia H02_22
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Heart Failure; Heart Disease; Cardiovascular Diseases; Synchronized Diaphragmatic Stimulation; Implantable Heart Failure Device Therapy

Outcome Measures

Primary Outcomes (2)

• Change in LVESV

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

  6 months

• 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

  12 months

Secondary Outcomes (2)

• Change in 6MHW distance

  6 months

• Change in MLWHF overall score

  6 months

Study Arms (2)

Therapy

EXPERIMENTAL

SDS system implanted and Therapy On for 6 months post randomization

Device: Synchronized Diaphragmatic Stimulation

Control

SHAM COMPARATOR

SDS system implanted and Therapy Off for 6 months post randomization

Device: Synchronized Diaphragmatic Stimulation

Interventions

Synchronized Diaphragmatic Stimulation DEVICE

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

Also known as: ADS, SDS, VisONE SDS

Control; Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VisCardia Inc.: lead
• Clinical Accelerator: collaborator

Study Sites (2)

Tbilisi Heart And Vascular Clinic

Tbilisi, 0159, Georgia

Location

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

Tashkent, 100115, Uzbekistan

Location

MeSH Terms

Conditions

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Tamaz Shaburishvili, MD, PhD

  Tbilisi Heart and Vascular Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigator blinded to device programming, therapy imperceptible to patient
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Partial crossover - initial randomized to therapy On/Off. Subsequent OFF converted to On after primary efficacy endpoint.

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: August 23, 2022
• Primary Completion: September 30, 2024
• Study Completion: February 28, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1); GE (1)