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REDUCE LAP-HF TRIAL II

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ClinicalTrials.gov Identifier: NCT03088033
Recruitment Status : Active, not recruiting
First Posted : March 23, 2017
Last Update Posted : February 22, 2023
Sponsor:
Information provided by (Responsible Party):
Corvia Medical

Study Description
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Brief Summary:
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

Condition or disease Intervention/treatment Phase
Heart Failure Device: IASD System II implant Other: intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) Not Applicable

Detailed Description:

Following supine bicycle exercise testing to assess eligibility, the eligible patients are randomized to the treatment or control group.

All patients will be sedated, and both treatment and control arm patients will undergo placement of a femoral venous access sheath after randomization.

Patients randomized to the 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. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.

Patients will be evaluated at pre-specified time intervals and followed for 5 years.

All patients will be unblinded after the 24 month follow up visit.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 608 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
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
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : July 29, 2021
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Patients randomized to the 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.
 Device: IASD System II implant
The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.
Sham Comparator: Control
Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
 Other: intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.


Outcome Measures
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Primary Outcome Measures :
  1. Composite Primary Endpoint [ Time Frame: Up to 24 months ]
    The primary endpoint is the composite of (a) incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months; (b) total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12 months follow-up, and time-to-first HF event; and (c) change in baseline KCCQ total summary score at 12 months.


Secondary Outcome Measures :
  1. Composite safety endpoint defined as follows: [ Time Frame: 12 months ]
    1. Cardiovascular mortality
    2. Non-fatal, ischemic stroke
    3. New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min)
    4. Major adverse cardiac events through 12-months defined as: i. Cardiac death; ii. Myocardial infarction; iii. Cardiac tamponade; iv. Emergency cardiac surgery
    5. Thrombo-embolic complications (TIA, systemic embolization)
    6. Newly acquired persistent or permanent AF or atrial flutter through
    7. ≥30% increase in RV size/decrease in TAPSE

  2. Rate of heart failure admissions [ Time Frame: Up to 24 months ]
    Total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits, or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12-month follow-up

  3. Change in NYHA Class [ Time Frame: 12 months ]
    Change in NYHA functional Class assessed by a blinded physician between baseline and 12 months

  4. Change in Kansas City Cardiomyopathy Questionnaire [ Time Frame: 12 months ]
    Change in KCCQ score between baseline and 12 months, categorized as ≤0, >0 - 5, >5 - 10, >10 - 15, >15 - 20, >20 - 25, >25.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

SELECT INCLUSION CRITERIA

  • Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

    • Symptoms of HF requiring current treatment with diuretics for ≥ 30 days AND
    • NYHA class II with a history of > NYHA class II; OR NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
    • ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
  • Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure (with no significant changes [>100% increase or 50% decrease], excluding diuretic dose change for a minimum of 4 weeks prior to screening) that is expected to be maintained without change for 6 months
  • Age ≥ 40 years old, LV ejection fraction (EF) ≥ 40% within the past 3 months, without previously documented EF <30% (within the past 3 years)
  • Elevated PCWP with a gradient compared to right atrial pressure (RAP), documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mmHg, and greater than RAP by ≥ 5 mmHg

SELECT EXCLUSION CRITERIA

  • MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months.
  • Cardiac Resynchronization Therapy initiated within the past 6 months

  • Advanced heart failure defined as one or more of the below:

    • ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF;
    • Cardiac index < 2.0 L/min/m2
    • Inotropic infusion (continuous or intermittent) for EF< 40% within the past 6 months
    • Patient is on the cardiac transplant waiting list
  • Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
  • History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months

  • Presence of significant valve disease defined by the site cardiologist as:

    • Mitral valve regurgitation defined as grade ≥ 3+ MR
    • Tricuspid valve regurgitation defined as grade ≥ 2+ TR
    • Aortic valve disease defined as ≥ 2+ AR or > moderate AS
  • Known clinically significant untreated carotid artery stenosis likely to require intervention
  • Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
Contacts and Locations
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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): NCT03088033


Locations
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Sponsors and Collaborators
Corvia Medical
Investigators
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Principal Investigator: Sanjiv Shah, MD Northwestern Memorial Hospital
Principal Investigator: Marty Leon, MD Columbia University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Corvia Medical
ClinicalTrials.gov Identifier: NCT03088033    
Other Study ID Numbers: 1601
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases