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Extended IASD Investigation: REDUCE LAP-HF IV

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.
 
ClinicalTrials.gov Identifier: NCT04632160
Recruitment Status : Not yet recruiting
First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Corvia Medical

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).


Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Heart Failure With Mid Range Ejection Fraction Device: IASD System II Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Treatment
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
The implant is placed across the interatrial septum using a percutaneous transcatheter approach.
Other Name: Interatrial Shunt Device




Primary Outcome Measures :
  1. Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months [ Time Frame: 12 Month ]
  2. 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 ]
  3. Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months [ Time Frame: 12 Month ]

Secondary Outcome Measures :
  1. Cardiovascular mortality through 12 months [ Time Frame: 12 Months ]
  2. Non-fatal, ischemic stroke through 12 months [ Time Frame: 12 Months ]
  3. 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 ]
  4. Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery. [ Time Frame: 12 Months ]
  5. Thrombo-embolic complications (TIA, systemic embolization) through 12 months [ Time Frame: 12 Months ]
  6. ≥30% increase in right ventricular size/decrease in TAPSE through 12 months [ Time Frame: 12 Months ]
  7. Newly acquired persistent or permanent AF or atrial flutter through 12 months [ Time Frame: 12 Months ]
  8. 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 ]
  9. Change in New York Heart Association (NYHA) functional Class between baseline and 12 months [ Time Frame: 12 Months ]
  10. 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 ]


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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 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

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): NCT04632160


Contacts
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Contact: Jan Komtebedde, DVM 978-654-6113 jkomtebedde@corviamedical.com
Contact: Katie Romcevich, BSBA kromcevich@corviamedical.com

Sponsors and Collaborators
Corvia Medical
Investigators
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Principal Investigator: Sanijv Shah, MD Northwestern Memorial Hospital
Principal Investigator: Marty Leon, MD Columbia University Irving Medical Center
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Responsible Party: Corvia Medical
ClinicalTrials.gov Identifier: NCT04632160    
Other Study ID Numbers: 2001
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
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