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Trial record 1 of 3 for:    REDUCE LAP-HF I
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REDUCE LAP-HF RANDOMIZED TRIAL I

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600234
Recruitment Status : Active, not recruiting
First Posted : November 9, 2015
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Corvia Medical

Brief Summary:
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Inter-Atrial Shunt Device Other: Intracardiac Echo Not Applicable

Detailed Description:
The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction >40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: REDUCE LAP-HF RANDOMIZED TRIAL I: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
Study Start Date : December 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Treatment with Inter-Atrial Shunt Device
Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.
Device: Inter-Atrial Shunt Device
An implantable device placed in the interatrial septum
Other Name: IASD

Placebo Comparator: Control
Once all study criteria have been met, if randomized to this arm, patients will not receive the implant. They will undergo an intracardiac echo only, with the option to crossover at 1 year.
Other: Intracardiac Echo
Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.




Primary Outcome Measures :
  1. Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE) [ Time Frame: 1 Month Post Implant ]

    The primary safety outcome measure is the incidence of one or more of the following major adverse cardiac, cerebrovascular embolic, or renal events (MACCRE) defined as:

    1. Cardiovascular death through 1-month post implant;
    2. Embolic stroke through 1-months post implant;
    3. Device and or procedure related adverse cardiac events through 1-month post implant;
    4. New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min) through 1-month post implant

  2. Change in supine exercise pulmonary capillary wedge pressure (PCWP) [ Time Frame: 1 Month Post Implant ]
    Change in supine exercise pulmonary capillary wedge pressure (PCWP), as assessed by an independent blinded hemodynamic core laboratory, across the four values measured at each visit (values at 20W, 40W, 60W and 80W).


Secondary Outcome Measures :
  1. Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline [ Time Frame: 1 Month ]
  2. Cardiovascular death [ Time Frame: 12 Months ]
  3. Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF [ Time Frame: 12 Months ]
  4. Change in Quality Of Life Questionnaire (EQ-5D) [ Time Frame: 12 Months ]
  5. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score) [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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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

Key Inclusion Criteria:

  • Chronic symptomatic Heart Failure
  • Ongoing stable GDMT HF management and management of potential comorbidities
  • Age ≥ 40 years old
  • LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction <30%.
  • Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg

Key Exclusion Criteria:

  • MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
  • Cardiac Resynchronization Therapy initiated within the past 6 months
  • Severe heart failure
  • 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
  • Known clinically significant untreated carotid artery stenosis
  • Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation

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): NCT02600234


Locations
Show Show 21 study locations
Sponsors and Collaborators
Corvia Medical
Investigators
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Principal Investigator: Sanjiv Shah, MD Northwestern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Corvia Medical
ClinicalTrials.gov Identifier: NCT02600234    
Other Study ID Numbers: 1501
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases