REDUCE LAP-HFREF TRIAL

NCT03093961 | Active Not Recruiting FDA Device

• 1 other identifier: 1502
• Study Type: interventional
• Target: 10
• Locations: 3 countries
• Sites: 4

Brief Summary

The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• The percent of subjects who experience major adverse cardiac and/or cerebrovascular events (MACCE)

  The primary endpoint will be peri-procedural, and 6 months Major Adverse Cardiac and Cerebrovascular Events (MACCE) and systemic embolic events in patients implanted with the IASD.

  6 months

• The percent of subjects who have successful device implantation

  Deployment at the intended location during the index procedure

  Index Procedure

• The percent of subjects left to right flow through the device

  Left to right flow through the device at 6 months as assessed by an echocardiographic core laboratory

  6 months

Study Arms (1)

Intervention

EXPERIMENTAL

IASD Implantation

Device: IASD implant

Interventions

IASD implant DEVICE

Single arm for implant

Intervention

Eligibility Criteria

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

You may qualify if:

• Chronic symptomatic Heart Failure (HF) documented by the following:
• New York Heart Association (NYHA) Class III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit, and signs (e.g. any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
• One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify), or one emergency department visit with IV treatment for HF within the 12 months prior to study entry
• Ongoing stable GDMT for HF (Class I, and IIa recommendations) according to the 2016 ACC/AHA Guidelines for the management of Heart Failure (with no significant changes \[\>100% increase or 50% decrease\], excluding diuretic dose changes for a minimum of 3 months prior to screening), which is expected to be maintained without change for 6 months
• Age ≥ 18 years old
• Reduced Left ventricular ejection fraction between 20% and 40% as documented by echocardiography, radio nuclide ventriculography, or MRI within the past 3 months
• Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by:
• a. Resting end expiratory PCWP ≥ 18 mmHg, and greater than RAP by ≥ 5 mmHg
• Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, as approved by the IRB
• Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
• Trans-septal catheterization by femoral vein access is determined to be feasible

You may not qualify if:

• Patients who are not receiving GDMT for specified reasons
• NT-Pro BNP \< 100 pg/mL (if in sinus rhythm), or \<300 pg/mL (if in atrial fibrillation); or BNP \< 70 pg/mL (if in sinus rhythm), or \< 200 pg/mL (if in atrial fibrillation)
• Myocardial infarction (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 3 months
• Automated Implantable Cardioverter Defibrillator (AICD) placed within past 3 months
• Severe heart failure defined by all of the following:
• ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
• Cardiac Index \< 2.0 L/min/m2
• Requiring inotropic infusion (continuous or intermittent) within the past 3 months.
• Listed on transplant waiting list
• Ability to perform the 6 minute walk Test \>600m
• Known clinically significant un-revascularized coronary artery disease, defined as: epi-cardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
• History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months or recurrent DVT/pulmonary emboli
• Presence of significant valve disease defined by echocardiography as:
• Mitral valve regurgitation defined as grade \> 2+ MR

Sponsors & Collaborators

• Corvia Medical: lead

Study Sites (4)

Mt. Sinai Hospital

New York, New York, 10029, United States

Location

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

St. Vincent Hospital

Sydney, Australia

Location

Homolka Hospital

Prague, Czechia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jan Komtebedde, DVM

  Corvia Medical

  STUDY DIRECTOR

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: March 15, 2017
• First Posted: March 28, 2017
• Study Start: March 10, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

US (1); AU (2); CZ (1)