Synchronized Diaphragmatic Stimulation for Heart Failure
(RECOVER-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Synchronized Diaphragmatic Stimulation, using the VisONE System, for individuals with heart failure. Researchers aim to determine if this device can safely and effectively enhance heart function. Participants will be divided into two groups: one will receive the new device therapy alongside standard medication, while the other will receive only standard medication for comparison. Individuals diagnosed with heart failure, who experience symptoms like shortness of breath, and meet specific heart condition criteria may be eligible to participate. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could advance heart failure treatments.
What prior data suggests that Synchronized Diaphragmatic Stimulation is safe for heart failure patients?
Research has shown that Synchronized Diaphragmatic Stimulation (SDS) is generally safe and well-tolerated. One study found that the procedure, involving a small surgery with a camera, did not raise safety concerns for patients. Another report confirmed the procedure's safety, noting that patients could walk and leave the hospital without major issues.
While risks such as bleeding or infection exist, these are common for similar procedures. Overall, evidence suggests that SDS is safe for people with heart failure and does not cause serious complications related to the therapy itself.12345Why are researchers excited about this trial?
Synchronized Diaphragmatic Stimulation (SDS) is unique because it targets the diaphragm to improve heart function in patients with heart failure, which is different from most treatments that focus on the heart itself. This approach uses the VisONE System to stimulate the diaphragm in sync with the heart, potentially enhancing cardiac performance by improving breathing and circulation. Researchers are excited about this treatment because it offers a novel way to support heart function, which could lead to better outcomes for patients when combined with standard heart failure medications.
What evidence suggests that Synchronized Diaphragmatic Stimulation is effective for heart failure?
Research has shown that Synchronized Diaphragmatic Stimulation (SDS) might improve heart function in people with heart failure. In this trial, participants will divide into two groups: one will receive the VisONE System programmed to deliver SDS alongside optimal medical management, while the other will receive medical management alone with the device programmed not to deliver SDS. Studies have found that SDS, when used properly, can help the heart fill with and pump blood more effectively. One study noted that SDS improved symptoms and overall heart performance over a year. Another study confirmed that SDS can be used safely and may boost heart function without safety concerns. Overall, early results suggest that SDS could be a promising way to help people with heart failure feel better and improve their heart health.13467
Who Is on the Research Team?
Lee R Goldberg, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Monitoring
Participants receive the VisONE System implant and are monitored for initial safety and device functionality
Randomized Treatment
Participants are randomized to either active SDS therapy or control (SDS therapy inactive) and continue receiving GDMT
Crossover Treatment
Control group participants have SDS therapy activated, and all participants continue receiving GDMT
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Synchronized Diaphragmatic Stimulation
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
* Subjects will be implanted with the VisONE System programmed to deliver SDS (Therapy On) and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines) including those drugs to be determined by the subject's physician * Assigned Interventions: * Device: VisONE System (SDS) * Drug: Medical Management
* Subjects will be implanted with the VisONE System programmed not to deliver SDS (Therapy Off) and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines) including those drugs to be determined by the subject's physician * Assigned Interventions: * Drug: Medical Management
Find a Clinic Near You
Who Is Running the Clinical Trial?
VisCardia Inc.
Lead Sponsor
Clinical Accelerator Ltd.
Collaborator
Duke Clinical Research Institute
Collaborator
Clinical Accelerator
Industry Sponsor
Citations
Synchronized Diaphragmatic Stimulation for Heart Failure ...
Conclusions. These data demonstrate that SDS can be delivered using alternative implantation methods without raising safety concerns and suggest improved ...
RECOVER-HF: A Sham-Controlled, Double-Blind Pivotal ...
Synchronized Diaphragmatic Stimulation (SDS) is a novel implantable device-based intervention designed to augment cardiac function by ...
"Synchronized Diaphragmatic Stimulation for Heart Failure ...
This study prospectively evaluated the safety and 1-year effectiveness of SDS in an expanded first-in-patient cohort using multiple implant methods.
Synchronized Diaphragmatic Stimulation for the Treatment ...
SDS is a novel approach designed to improve cardiac function, symptoms, and, ultimately, outcomes for patients who are symptomatic for HFrEF.
Synchronized diaphragmatic stimulation for heart failure ...
VisONE-HF is a first-in-patient, observational study assessing the feasibility and 1 year effects of a novel, minimally invasive SDS device.
Synchronized diaphragmatic stimulation for heart failure using ...
These data demonstrate the feasibility of laparoscopic implantation and delivery of SDS without raising safety concerns. These encouraging ...
Synchronized diaphragmatic stimulation for the treatment of ...
Synchronized diaphragmatic stimulation (SDS) is a novel approach designed to improve cardiac function, symptoms and, ultimately, outcomes for heart failure ...
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