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Trial record 3 of 7 for:    IASD

REDUCE LAP-HFREF TRIAL

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ClinicalTrials.gov Identifier: NCT03093961
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Corvia Medical

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Heart Failure Device: IASD implant Not Applicable

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,


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Intervention
IASD Implantation
Device: IASD implant
Single arm for implant




Primary Outcome Measures :
  1. The percent of subjects who experience major adverse cardiac and/or cerebrovascular events (MACCE) [ Time Frame: 6 months ]
    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.

  2. The percent of subjects who have successful device implantation [ Time Frame: Index Procedure ]
    Deployment at the intended location during the index procedure

  3. The percent of subjects left to right flow through the device [ Time Frame: 6 months ]
    Left to right flow through the device at 6 months as assessed by an echo-cardiographic core laboratory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chronic symptomatic Heart Failure (HF) documented by the following:

    1. 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
    2. 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
  2. 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
  3. Age ≥ 18 years old
  4. Reduced Left ventricular ejection fraction between 20% and 40% as documented by echocardiography, radio nuclide ventriculography, or MRI within the past 3 months
  5. 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

  6. 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
  7. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams

Exclusion Criteria:

  1. Patients who are not receiving GDMT for specified reasons
  2. NT-Pro BNP < 100 pmol/L (if in sinus rhythm), or <300 pmol/L (if in atrial fibrillation)
  3. Myocardial infarction (MI) and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
  4. Cardiac Resynchronization Therapy initiated within the past 3 months
  5. Automated Implantable Cardioverter Defibrillator (AICD) placed within past 3 months
  6. Severe heart failure defined by all of the following:

    1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
    2. Cardiac Index < 2.0 L/min/m2
    3. Requiring inotropic infusion (continuous or intermittent) within the past 3 months.
    4. Listed on transplant waiting list
  7. Ability to perform the 6 minute walk Test >600m
  8. Known clinically significant un-revascularized coronary artery disease, defined as: epi-cardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
  9. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months or recurrent DVT/pulmonary emboli
  10. Presence of significant valve disease defined by echocardiography as:

    1. Mitral valve regurgitation defined as grade > 2+ MR
    2. Tricuspid valve regurgitation defined as grade > 2+ TR;
    3. Aortic valve disease defined as ≥ 2+ AR or moderate AS
  11. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin analogue; or has a documented coagulopathy
  12. Atrial fibrillation with resting HR > 100 BPM
  13. Arterial Oxygen saturation < 95% on room air
  14. Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase; Hepatic cirrhosis; Hypoalbuminemia
  15. Resting RAP > 14 mmHg
  16. Right ventricular dysfunction, defined as

    1. More than mild RV dysfunction as determined by TTE: OR
    2. TAPSE < 1.4 cm: OR
    3. RV volume ≥ LV volume on echo estimate; OR
    4. Evidence of RV dysfunction defined by echo as an RV fractional area change < 35%
  17. Evidence of pulmonary hypertension with PVR ≥4 Woods Units
  18. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 <1L.
  19. Currently participating in an investigational drug or device study that may interfere with the conduct and outcome of this study.
  20. Life expectancy less than 12 months for non-cardiovascular reasons
  21. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
  22. Known or suspected allergy to nickel
  23. Women of child bearing potential
  24. Currently requiring dialysis; or e-GFR <25ml/min
  25. Systolic blood pressure >170 mmHg despite appropriate medical management
  26. Subjects with existing Atrial Septal Defects. Subjects with a Patent Foramen Ovale (PFO), who have elevated filling pressure despite the PFO are allowed
  27. Subjects on immunosuppression or systemic steroid treatment
  28. In the opinion of the investigator, the subject is not an appropriate candidate for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093961


Contacts
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Contact: Jan Komtebedde, DVM 9786546113 jkomtebedde@corviamedical.com
Contact: Jennifer Seale, MPH 9786546124 jseale@corviamedical.com

Locations
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United States, New York
Mt. Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Srinivas Dukkupati, MD         
Australia
St. Vincent Hospital Recruiting
Sydney, Australia
Contact: David Muller, MD         
Czechia
Homolka Hospital Recruiting
Prague, Czechia
Contact: Petr Neuzil, MD         
Sponsors and Collaborators
Corvia Medical
Investigators
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Study Director: Jan Komtebedde, DVM Corvia Medical

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Responsible Party: Corvia Medical
ClinicalTrials.gov Identifier: NCT03093961     History of Changes
Other Study ID Numbers: 1502
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases