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REDUCE LAP-HF TRIAL II (REDUCELAPHF II)

This study is currently recruiting participants.
Verified October 2017 by Corvia Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT03088033
First Posted: March 23, 2017
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Corvia Medical
  Purpose
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

Condition Intervention
Heart Failure Device: IASD System II implant Other: intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Corvia Medical:

Primary Outcome Measures:
  • Cardiovascular mortality or non-fatal, ischemic stroke through 6 months; 2. Change in baseline KCCQ at 6 months. [ Time Frame: 6 months ]
    Treatment groups will be compared over time through 6 months at a two-sided 0.05 level of significance across the composite primary endpoint using the Finkelstein-Schoenfeld approach


Secondary Outcome Measures:
  • Composite of Cardiovascular mortality through 12 months and Rate of total HF admissions/healthcare facility visits for IV or intensification of oral diuresis for HF through 12 months; 3. Change in KCCQ score between baseline and 12 months. [ Time Frame: 12 months ]
    The composite major secondary endpoint will be compared between treatments using the Finkelstein-Schoenfeld method

  • Change in 6MWT distance between baseline and 6 months. [ Time Frame: 6 months ]
    Analysis on this endpoint will be performed on the ITT and PP populations, with the ITT considered the primary analysis population.


Estimated Enrollment: 380
Actual Study Start Date: June 1, 2017
Estimated Study Completion Date: July 2024
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
    • NYHA class II with a history of > NYHA class II; 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 (emergency department/acute care 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 LA pressure 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 OR a > 10 mmHg increase of end-expiratory PCWP during supine ergometer exercise compared to resting PCWP, 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
  • Severe 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
  • Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
  Contacts and Locations
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


Contacts
Contact: Jan Komtebedde, DVM 978-654-6113 jkomtebedde@corviamedical.com
Contact: Jennifer Seale, MPH 978-654-6124 jseale@corviamedical.com

  Show 45 Study Locations
Sponsors and Collaborators
Corvia Medical
Investigators
Principal Investigator: Sanjiv Shah, MD Northwestern Memorial Hospital
Principal Investigator: Ted Feldman, MD Evanston Northshore Healthcare
  More Information

Responsible Party: Corvia Medical
ClinicalTrials.gov Identifier: NCT03088033     History of Changes
Other Study ID Numbers: Protocol 1601
First Submitted: March 14, 2017
First Posted: March 23, 2017
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Heart Failure
Heart Diseases
Cardiovascular Diseases