Philadelphia, PANCT06552637Now EnrollingIRB Ready

Heart Failure With Reduced Ejection Fraction Clinical Trial in Philadelphia, PA

Access cutting-edge heart failure with reduced ejection fraction treatment through this clinical trial at a research site in Philadelphia. Study-provided care at no cost to qualified participants.

Sponsored by VisCardia Inc.

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Expert Care in Philadelphia

Access heart failure with reduced ejection fraction specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related heart failure with reduced ejection fraction treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Philadelphia

    Convenient for PA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Philadelphia site if eligible
  4. 4Begin participation

About This Heart Failure With Reduced Ejection Fraction Study in Philadelphia

RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.

Sponsor: VisCardia Inc.

Who Can Participate

Inclusion Criteria

NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT)
QRS duration ≤ 130 ms

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
Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF (\> 24 hours), symptomatic NSVT or DCCV
Any inotropic drug treatment within the previous 3 months
Bradycardia (heart rate \< 50 beats/min), atrial arrhythmias with rates \> 100 beats/min, sustained ventricular tachycardia or frequent ventricular ectopy \>10% present during screening
Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy \> 10% documented within the previous 3 months
Reversible non-ischemic cardiomyopathy
Valvular disease requiring intervention within the next 12 months or presence of significant valve disease as determined by the site cardiologist as:
Greater than mild mitral valve stenosis
Greater than moderate mitral valve regurgitation
Greater than mild tricuspid valve stenosis
Greater than moderate-severe tricuspid valve regurgitation
Greater than moderate aortic stenosis
Greater than moderate aortic regurgitation
Greater than mild-moderate pulmonic stenosis
Greater than moderate pulmonic regurgitation
Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys \>70 mmHg at rest
Severe COPD, other respiratory or lung diseases where FEV \< 50%
Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months
Known history of diaphragmatic paralysis or suspicion confirmed by unilateral or bilateral elevation of the diaphragm on chest x-ray
Pericardial disease
Diabetic neuropathy
Existing diaphragmatic stimulation for respiration assist
Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months); or CRT that is indicated or implanted and functional
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
Known allergies to implantable device materials
History of systemic infection requiring the use of intravenous antibiotics within the previous 3 months

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT06552637) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure With Reduced Ejection Fraction Treatment Options in Philadelphia, PA

If you're searching for heart failure with reduced ejection fraction treatment options in Philadelphia, PA, this clinical trial (NCT06552637) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure with reduced ejection fraction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure with reduced ejection fraction clinical trials near you to find additional studies recruiting in your area.

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