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RECOVER-HF Pilot Study of SDS in Heart Failure

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Georgia

Study Type

Interventional

Intervention

Synchronized Diaphragmatic Stimulation

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Heart Failure, Heart Disease, Cardiovascular Diseases, Synchronized Diaphragmatic Stimulation, Implantable Heart Failure Device Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tbilisi Heart And Vascular Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Therapy

Control

Arm Description

SDS system implanted and Therapy On for 6 months post randomization

SDS system implanted and Therapy Off for 6 months post randomization

Outcomes

Primary Outcome Measures

Change in LVESV

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

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: CV Death Stroke Cardiac Arrest Interaction with cardiac rhythm device requiring permanent termination of SDS therapy Acute Heart Failure Decompensation Infection requiring device/lead explant Diaphragmatic dysfunction leading to a clinically significant reduction is respiratory function Inadequate SDS therapy delivery requiring surgical intervention Injury to abdominal organs requiring surgical intervention Pneumothorax Hemothorax Peritonitis

Secondary Outcome Measures

Change in 6MHW distance

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

Change in MLWHF overall score

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

Full Information

NCT ID

NCT05592392

First Posted

October 19, 2022

Last Updated

October 22, 2022

Sponsor

VisCardia Inc.

Collaborators

Clinical Accelerator Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05592392

Brief Title

RECOVER-HF Pilot Study of SDS in Heart Failure

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 23, 2022 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VisCardia Inc.

Collaborators

Clinical Accelerator Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure With Reduced Ejection Fraction

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigator

Masking Description

Investigator blinded to device programming, therapy imperceptible to patient

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Therapy

Arm Type

Experimental

Arm Description

SDS system implanted and Therapy On for 6 months post randomization

Arm Title

Control

Arm Type

Sham Comparator

Arm Description

SDS system implanted and Therapy Off for 6 months post randomization

Intervention Type

Device

Intervention Name(s)

Synchronized Diaphragmatic Stimulation

Other Intervention Name(s)

ADS, SDS, VisONE SDS

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in LVESV

Description

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

Time Frame

6 months

Title

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

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in 6MHW distance

Description

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

Time Frame

6 months

Title

Change in MLWHF overall score

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tamaz Shaburishvili, MD, PhD

Organizational Affiliation

Tbilisi Heart and Vascular Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tbilisi Heart And Vascular Clinic

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

12. IPD Sharing Statement

Plan to Share IPD

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RECOVER-HF Pilot Study of SDS in Heart Failure

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