RECOVER-HF Pilot Study of SDS in Heart Failure

NCT ID: NCT05592392

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2025-02-28

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.

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Therapy

SDS system implanted and Therapy On for 6 months post randomization

Group Type: EXPERIMENTAL

Synchronized Diaphragmatic Stimulation

Intervention Type: DEVICE

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

Control

SDS system implanted and Therapy Off for 6 months post randomization

Group Type: SHAM_COMPARATOR

Synchronized Diaphragmatic Stimulation

Intervention Type: DEVICE

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

Interventions

Synchronized Diaphragmatic Stimulation

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

Intervention Type: DEVICE

Other Intervention Names

ADS, SDS, VisONE SDS

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Accelerator

INDUSTRY

Sponsor Role: collaborator

VisCardia Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamaz Shaburishvili, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tbilisi Heart and Vascular Clinic

Locations

Tbilisi Heart And Vascular Clinic

Tbilisi, , Georgia

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

Tashkent, , Uzbekistan

Countries

Georgia; Uzbekistan

Other Identifiers

VisCardia H02_22

Identifier Type: -

Identifier Source: org_study_id