Heart Failure With Preserved Ejection Fraction Clinical Trial
Official title:
A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
NCT number | NCT04632160 |
Other study ID # | 2001 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2021 |
Est. completion date | January 1, 2027 |
Verified date | July 2021 |
Source | Corvia Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 1, 2027 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Corvia Medical |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months | 12 Month | ||
Primary | 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 | Up to 24 Months | ||
Primary | Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months | 12 Month | ||
Secondary | Cardiovascular mortality through 12 months | 12 Months | ||
Secondary | Non-fatal, ischemic stroke through 12 months | 12 Months | ||
Secondary | New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min/1.73 m2) through 12 months | 12 Months | ||
Secondary | Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery. | 12 Months | ||
Secondary | Thrombo-embolic complications (TIA, systemic embolization) through 12 months | 12 Months | ||
Secondary | =30% increase in right ventricular size/decrease in TAPSE through 12 months | 12 Months | ||
Secondary | Newly acquired persistent or permanent AF or atrial flutter through 12 months | 12 Months | ||
Secondary | 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 | Up to 24 months | ||
Secondary | Change in New York Heart Association (NYHA) functional Class between baseline and 12 months | 12 Months | ||
Secondary | 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. | 12 Months |
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