REDUCE LAP-HFREF TRIAL (NCT03093961)

🧪 Interventions in This Study

• IASD implant (DEVICE)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Chronic symptomatic Heart Failure (HF) documented by the following:
2. New York Heart Association (NYHA) Class III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit, and signs (e.g. any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
3. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify), or one emergency department visit with IV treatment for HF within the 12 months prior to study entry
4. Ongoing stable GDMT for HF (Class I, and IIa recommendations) according to the 2016 ACC/AHA Guidelines for the management of Heart Failure (with no significant changes \[\>100% increase or 50% decrease\], excluding diuretic dose changes for a minimum of 3 months prior to screening), which is expected to be maintained without change for 6 months
5. Age ≥ 18 years old
6. Reduced Left ventricular ejection fraction between 20% and 40% as documented by echocardiography, radio nuclide ventriculography, or MRI within the past 3 months
7. Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by: a. Resting end expiratory PCWP ≥ 18 mmHg, and greater than RAP by ≥ 5 mmHg
8. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, as approved by the IRB
9. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
10. Trans-septal catheterization by femoral vein access is determined to be feasible

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

• Mt. Sinai Hospital — New York, New York
• John Hunter Hospital — New Lambton Heights, New South Wales
• St. Vincent Hospital — Sydney,
• Homolka Hospital — Prague,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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• Physiological Effects Ketone Ester in Heart — Cleveland, Ohio
• Staged Kidney Transplantation During Combined Heart/Kidney Transplantation — Los Angeles, California
• Alleviant ALLAY-HFrEF Study — Los Angeles, California
• A Research Study Comparing Different Doses of CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy — Birmingham, Alabama

Explore by condition: All Heart Failure clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.