Extended IASD Investigation: REDUCE LAP-HF IV

NCT04632160 | Withdrawn FDA Device

• 1 other identifier: 2001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Heart Failure With Preserved Ejection Fraction; Heart Failure With Mid Range Ejection Fraction

Outcome Measures

Primary Outcomes (3)

• Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months

  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

  Up to 24 Months

• Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months

  12 Month

Secondary Outcomes (10)

• Cardiovascular mortality through 12 months

  12 Months

• Non-fatal, ischemic stroke through 12 months

  12 Months

• New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min/1.73 m2) through 12 months

  12 Months

• Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery.

  12 Months

• Thrombo-embolic complications (TIA, systemic embolization) through 12 months

  12 Months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

IASD System II DEVICE

The implant is placed across the interatrial septum using a percutaneous transcatheter approach.

Also known as: Interatrial Shunt Device

Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corvia Medical: lead

Study Officials

• Sanijv Shah, MD

  Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Marty Leon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 17, 2020
• Study Start: December 1, 2021
• Primary Completion: January 1, 2022
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share