Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-12-01
2027-01-01
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
IASD System II
The implant is placed across the interatrial septum using a percutaneous transcatheter approach.
Interventions
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IASD System II
The implant is placed across the interatrial septum using a percutaneous transcatheter approach.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Corvia Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Sanijv Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital
Marty Leon, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Other Identifiers
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2001
Identifier Type: -
Identifier Source: org_study_id
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