REDUCE LAP-HFREF TRIAL

Running, not enrolling · Not applicable

Conditions studied: Heart Failure

In brief

The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT).

Key facts

Study ID

NCT03093961

Run by

Corvia Medical

People needed

10

Starts

2017-03-10

Expected to finish

2027-12-01

Last updated by the study team

2024-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic symptomatic Heart Failure (HF) documented by the following:
• 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
• 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
• 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
• Age ≥ 18 years old
• Reduced Left ventricular ejection fraction between 20% and 40% as documented by echocardiography, radio nuclide ventriculography, or MRI within the past 3 months
• 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
• 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
• Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
• Trans-septal catheterization by femoral vein access is determined to be feasible

You may not qualify if…

• Patients who are not receiving GDMT for specified reasons
• NT-Pro BNP < 100 pg/mL (if in sinus rhythm), or <300 pg/mL (if in atrial fibrillation); or BNP < 70 pg/mL (if in sinus rhythm), or < 200 pg/mL (if in atrial fibrillation)
• Myocardial infarction (MI) and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
• Cardiac Resynchronization Therapy initiated within the past 3 months
• Automated Implantable Cardioverter Defibrillator (AICD) placed within past 3 months
• Severe heart failure defined by all of the following:
• ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
• Cardiac Index < 2.0 L/min/m2
• Requiring inotropic infusion (continuous or intermittent) within the past 3 months.
• Listed on transplant waiting list
• Ability to perform the 6 minute walk Test >600m
• Known clinically significant un-revascularized coronary artery disease, defined as: epi-cardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
• History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months or recurrent DVT/pulmonary emboli
• Presence of significant valve disease defined by echocardiography as:
• Mitral valve regurgitation defined as grade > 2+ MR
• Tricuspid valve regurgitation defined as grade > 2+ TR;
• Aortic valve disease defined as ≥ 2+ AR or moderate AS
• Subject is contraindicated to receive either dual antiplatelet therapy or warfarin analogue; or has a documented coagulopathy
• Atrial fibrillation with resting HR > 100 BPM
• Arterial Oxygen saturation < 95% on room air
• Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase; Hepatic cirrhosis; Hypoalbuminemia
• Resting RAP > 14 mmHg
• Right ventricular dysfunction, defined as
• More than mild RV dysfunction as determined by TTE: OR
• TAPSE < 1.4 cm: OR

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.