- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03093961
REDUCE LAP-HFREF TRIAL
A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure With Reduced Ejection Fraction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The intended clinical indication of the IASD System II is the reduction of elevated LAP in patients with symptomatic heart failure with reduced ejection fraction, despite appropriate medical management. The implant is designed with a center barrel opening that, in the setting of elevated LAP, allows left to right flow. Since many of the symptoms these patients experience are believed to be due to elevated LAP, the IASD System II has the potential to significantly reduce symptoms and improve the quality of life in patients with otherwise limited treatment options.
The study design is a prospective, non-randomized, single-arm feasibility trial. This study will implant up to 10 subjects. The population will include heart failure patients with reduced ejection fraction, and elevated left sided filling pressures, who remain symptomatic despite GDMT, including optimal doses of recommended pharmaceutical treatments, surgical, and device intervention(s) (CRT, AICD, reduction of MRI). After analysis of the 1 month results (including baseline and 1 month Core laboratory echocardiographic and hemodynamic data) of the first 5 implanted patients, a decision will be made to implant an additional 5 patients,
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sydney, Australia
- St. Vincent Hospital
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New South Wales
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New Lambton Heights, New South Wales, Australia, 2305
- John Hunter Hospital
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Prague, Czechia
- Homolka Hospital
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New York
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New York, New York, United States, 10029
- Mt. Sinai Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
- RV volume ≥ LV volume on echo estimate; OR
- Evidence of RV dysfunction defined by echo as an RV fractional area change < 35%
- Evidence of pulmonary hypertension with PVR ≥4 Woods Units
- Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 <1L.
- Currently participating in an investigational drug or device study that may interfere with the conduct and outcome of this study.
- Life expectancy less than 12 months for non-cardiovascular reasons
- Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
- Known or suspected allergy to nickel
- Women of child bearing potential
- Currently requiring dialysis; or e-GFR <25ml/min
- Systolic blood pressure >170 mmHg despite appropriate medical management
- Subjects with existing or surgically closed (with a patch) Atrial Septal Defects. Subjects with a Patent Foramen Ovale (PFO), who have elevated filling pressure despite the PFO are allowed
- Subjects on immunosuppression or systemic steroid treatment
- In the opinion of the investigator, the subject is not an appropriate candidate for the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention
IASD Implantation
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Single arm for implant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percent of subjects who experience major adverse cardiac and/or cerebrovascular events (MACCE)
Time Frame: 6 months
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The primary endpoint will be peri-procedural, and 6 months Major Adverse Cardiac and Cerebrovascular Events (MACCE) and systemic embolic events in patients implanted with the IASD.
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6 months
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The percent of subjects who have successful device implantation
Time Frame: Index Procedure
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Deployment at the intended location during the index procedure
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Index Procedure
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The percent of subjects left to right flow through the device
Time Frame: 6 months
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Left to right flow through the device at 6 months as assessed by an echocardiographic core laboratory
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jan Komtebedde, DVM, Corvia Medical
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1502
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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