Extended IASD Investigation: REDUCE LAP-HF IV
Primary Purpose
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IASD System II
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months
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
Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months
Secondary Outcome Measures
Cardiovascular mortality through 12 months
Non-fatal, ischemic stroke through 12 months
New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min/1.73 m2) through 12 months
Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery.
Thrombo-embolic complications (TIA, systemic embolization) through 12 months
≥30% increase in right ventricular size/decrease in TAPSE through 12 months
Newly acquired persistent or permanent AF or atrial flutter through 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
Change in New York Heart Association (NYHA) functional Class between baseline and 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04632160
Brief Title
Extended IASD Investigation: REDUCE LAP-HF IV
Official Title
A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn pending formal analysis of REDUCE LAP-HF II Pivotal Study results
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corvia Medical
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
IASD System II
Other Intervention Name(s)
Interatrial Shunt Device
Intervention Description
The implant is placed across the interatrial septum using a percutaneous transcatheter approach.
Primary Outcome Measure Information:
Title
Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months
Time Frame
12 Month
Title
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
Title
Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months
Time Frame
12 Month
Secondary Outcome Measure Information:
Title
Cardiovascular mortality through 12 months
Time Frame
12 Months
Title
Non-fatal, ischemic stroke through 12 months
Time Frame
12 Months
Title
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
Title
Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery.
Time Frame
12 Months
Title
Thrombo-embolic complications (TIA, systemic embolization) through 12 months
Time Frame
12 Months
Title
≥30% increase in right ventricular size/decrease in TAPSE through 12 months
Time Frame
12 Months
Title
Newly acquired persistent or permanent AF or atrial flutter through 12 months
Time Frame
12 Months
Title
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
Title
Change in New York Heart Association (NYHA) functional Class between baseline and 12 months
Time Frame
12 Months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanijv Shah, MD
Organizational Affiliation
Northwestern Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marty Leon, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extended IASD Investigation: REDUCE LAP-HF IV
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