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Trial record 1 of 9 for:    IASD
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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

Tracking Information
First Submitted Date  ICMJE November 6, 2020
First Posted Date  ICMJE November 17, 2020
Last Update Posted Date November 17, 2020
Estimated Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2020)
  • Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months [ Time Frame: 12 Month ]
  • 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 ]
  • Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months [ Time Frame: 12 Month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2020)
  • Cardiovascular mortality through 12 months [ Time Frame: 12 Months ]
  • Non-fatal, ischemic stroke through 12 months [ Time Frame: 12 Months ]
  • 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 ]
  • Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery. [ Time Frame: 12 Months ]
  • Thrombo-embolic complications (TIA, systemic embolization) through 12 months [ Time Frame: 12 Months ]
  • ≥30% increase in right ventricular size/decrease in TAPSE through 12 months [ Time Frame: 12 Months ]
  • Newly acquired persistent or permanent AF or atrial flutter through 12 months [ Time Frame: 12 Months ]
  • 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 ]
  • Change in New York Heart Association (NYHA) functional Class between baseline and 12 months [ Time Frame: 12 Months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extended IASD Investigation: REDUCE LAP-HF IV
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, 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).

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure With Preserved Ejection Fraction
  • Heart Failure With Mid Range Ejection Fraction
Intervention  ICMJE Device: IASD System II
The implant is placed across the interatrial septum using a percutaneous transcatheter approach.
Other Name: Interatrial Shunt Device
Study Arms  ICMJE 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.
Intervention: Device: IASD System II
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 11, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2027
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04632160
Other Study ID Numbers  ICMJE 2001
Has Data Monitoring Committee No
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: Sanijv Shah, MD Northwestern Memorial Hospital
Principal Investigator: Marty Leon, MD Columbia University Irving Medical Center
PRS Account Corvia Medical
Verification Date November 2020

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