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Extended IASD Investigation: REDUCE LAP-HF IV

Primary Purpose

Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IASD System II
Sponsored by
Corvia Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Select Inclusion Criteria:

  • Chronic symptomatic heart failure with preserved or mid-range left ventricular ejection fraction (HFpEF or HFrEF)
  • Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams

Select Exclusion Criteria:

  • Myocardial infarction and/or percutaneous cardiac intervention within past 3 months; Coronary artery bypass surgery in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months
  • Advanced heart failure
  • History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
  • Significant heart valve disease
  • Chronic pulmonary disease
  • Women of childbearing potential
  • Severe obstructive sleep apnea not treated with CPAP or other measures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure.

    Outcomes

    Primary Outcome Measures

    Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months
    Total rate (first plus recurrent) per patient year of heart failure (HF) admissions or healthcare facility visits for IV diuresis for HF up to 24 months, analyzed when the last subject completes 12 month follow-up, and time-to-first HF event
    Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months

    Secondary Outcome Measures

    Cardiovascular mortality through 12 months
    Non-fatal, ischemic stroke through 12 months
    New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min/1.73 m2) through 12 months
    Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery.
    Thrombo-embolic complications (TIA, systemic embolization) through 12 months
    ≥30% increase in right ventricular size/decrease in TAPSE through 12 months
    Newly acquired persistent or permanent AF or atrial flutter through 12 months
    Total rate per patient year of heart failure admissions or healthcare facility visits for IV diuresis or visits with intensification of oral diuresis for HF through 24 months, analyzed when the last subject completes 12 months follow-up
    Change in New York Heart Association (NYHA) functional Class between baseline and 12 months
    Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score between baseline and 12 months, categorized as ≤0, >0 - 5, >5 - 10, >10 - 15, >15 - 20, >20 - 25, >25.

    Full Information

    First Posted
    November 6, 2020
    Last Updated
    July 26, 2021
    Sponsor
    Corvia Medical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04632160
    Brief Title
    Extended IASD Investigation: REDUCE LAP-HF IV
    Official Title
    A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawn pending formal analysis of REDUCE LAP-HF II Pivotal Study results
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    January 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Corvia Medical

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Multicenter, Prospective, Open Label, Single Arm, Clinical Trial. The primary objective of this clinical trial is to further evaluate the safety and clinical efficacy of the IASD System II in symptomatic heart failure patients with an left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT); and to compare the safety and efficacy results to those from the treatment arm of the REDUCE LAP-HF Randomized Trial II (Corvia protocol 1601).
    Detailed Description
    Participants are screened against non-invasive eligibility criteria and scheduled for a hemodynamic evaluation. Following right heart catheterization at rest and during supine bicycle exercise, patients will undergo a brief intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) exam for septal suitability. Eligible patients continue with, fluoroscopically and echo guided transseptal puncture and IASD System II implant procedure. If a previously unknown protocol exclusion is discovered during the index procedure, and device is not implanted, participant is followed for 30 days, and then exits the study. Participants return for follow-up exams 30 days after the implant procedure and annually for 5 years after the implant procedure. In-person visits will take place for the first 2 years. Telephone follow-up and medical chart review will be conducted for years 3-5.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure.
    Intervention Type
    Device
    Intervention Name(s)
    IASD System II
    Other Intervention Name(s)
    Interatrial Shunt Device
    Intervention Description
    The implant is placed across the interatrial septum using a percutaneous transcatheter approach.
    Primary Outcome Measure Information:
    Title
    Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months
    Time Frame
    12 Month
    Title
    Total rate (first plus recurrent) per patient year of heart failure (HF) admissions or healthcare facility visits for IV diuresis for HF up to 24 months, analyzed when the last subject completes 12 month follow-up, and time-to-first HF event
    Time Frame
    Up to 24 Months
    Title
    Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months
    Time Frame
    12 Month
    Secondary Outcome Measure Information:
    Title
    Cardiovascular mortality through 12 months
    Time Frame
    12 Months
    Title
    Non-fatal, ischemic stroke through 12 months
    Time Frame
    12 Months
    Title
    New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min/1.73 m2) through 12 months
    Time Frame
    12 Months
    Title
    Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery.
    Time Frame
    12 Months
    Title
    Thrombo-embolic complications (TIA, systemic embolization) through 12 months
    Time Frame
    12 Months
    Title
    ≥30% increase in right ventricular size/decrease in TAPSE through 12 months
    Time Frame
    12 Months
    Title
    Newly acquired persistent or permanent AF or atrial flutter through 12 months
    Time Frame
    12 Months
    Title
    Total rate per patient year of heart failure admissions or healthcare facility visits for IV diuresis or visits with intensification of oral diuresis for HF through 24 months, analyzed when the last subject completes 12 months follow-up
    Time Frame
    Up to 24 months
    Title
    Change in New York Heart Association (NYHA) functional Class between baseline and 12 months
    Time Frame
    12 Months
    Title
    Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score between baseline and 12 months, categorized as ≤0, >0 - 5, >5 - 10, >10 - 15, >15 - 20, >20 - 25, >25.
    Time Frame
    12 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Select Inclusion Criteria: Chronic symptomatic heart failure with preserved or mid-range left ventricular ejection fraction (HFpEF or HFrEF) Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams Select Exclusion Criteria: Myocardial infarction and/or percutaneous cardiac intervention within past 3 months; Coronary artery bypass surgery in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months Advanced heart failure History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months Significant heart valve disease Chronic pulmonary disease Women of childbearing potential Severe obstructive sleep apnea not treated with CPAP or other measures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sanijv Shah, MD
    Organizational Affiliation
    Northwestern Memorial Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marty Leon, MD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Extended IASD Investigation: REDUCE LAP-HF IV

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