REDUCE LAP-HF RANDOMIZED TRIAL I

Corvia Medical

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Other: Intracardiac Echo; Device: Inter-Atrial Shunt Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02600234

1501

Details and patient eligibility

About

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

Full description

The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction >40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated.

Enrollment: 44 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Chronic symptomatic Heart Failure
• Ongoing stable GDMT HF management and management of potential comorbidities
• Age ≥ 40 years old
• LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction <30%.
• Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg

Key Exclusion Criteria:

• MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
• Cardiac Resynchronization Therapy initiated within the past 6 months
• Severe heart failure
• Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
• History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
• Presence of significant valve disease
• Known clinically significant untreated carotid artery stenosis
• Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Treatment with Inter-Atrial Shunt Device

Experimental group

Description:

Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.

Treatment:

Device: Inter-Atrial Shunt Device

Control

Placebo Comparator group

Description:

Once all study criteria have been met, if randomized to this arm, patients will not receive the implant. They will undergo an intracardiac echo only, with the option to crossover at 1 year.

Treatment:

Other: Intracardiac Echo