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REDUCE LAP-HF TRIAL II

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ClinicalTrials.gov Identifier: NCT03088033
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Corvia Medical

Tracking Information
First Submitted Date  ICMJE March 14, 2017
First Posted Date  ICMJE March 23, 2017
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
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) admissions or healthcare facility visits for IV diuresis 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • 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
  • Rate of heart failure admissions [ Time Frame: Up to 24 months ]
    Total rate (first plus recurrent) per patient year of heart failure (HF) admissions or healthcare facility visits for IV diuresis, or visits with intensification of oral diuresis for HF up to 24 months, analyzed when the last randomized subject completes 12-month follow-up
  • Change in NYHA Class [ Time Frame: 12 months ]
    Change in NYHA functional Class assessed by a blinded physician between baseline and 12 months
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REDUCE LAP-HF TRIAL II
Official Title  ICMJE A Study to Evaluate the Corvia Medical, Inc. IASD® System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure
Brief Summary Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
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. Patients randomized to the control arm will be allowed to cross-over to the treatment arm at ≥ 24 months post-control procedure provided patient selection criteria are met at that time. Cross-over patients will then be followed for 5 years after cross-over.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: IASD System II implant
  • 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.
    Intervention: Other: intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2018)
608
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE August 2027
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 5 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jan Komtebedde, DVM 978-654-6113 jkomtebedde@corviamedical.com
Contact: Katie Romcevich, BSBA kromcevich@corviamedical.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Croatia,   Denmark,   France,   Germany,   Italy,   Japan,   Netherlands,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03088033
Other Study ID Numbers  ICMJE 1601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Corvia Medical
Study Sponsor  ICMJE Corvia Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanjiv Shah, MD Northwestern Memorial Hospital
Principal Investigator: Marty Leon, MD Columbia University Irving Medical Center
PRS Account Corvia Medical
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP