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Active, Not Recruiting

NCT Number: NCT02600234

REDUCE LAP-HF RANDOMIZED TRIAL I

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Alfred Hospital, Melbourne, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inter-Atrial Shunt Device

Device

An implantable device placed in the interatrial septum

Other names: IASD

Intracardiac Echo

Other

Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.

Primary outcomes

  1. Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE)

    Time frame: 1 Month Post Implant

    The primary safety outcome measure is the incidence of one or more of the following major adverse cardiac, cerebrovascular embolic, or renal events (MACCRE) defined as:

    • Cardiovascular death through 1-month post implant;
    • Embolic stroke through 1-months post implant;
    • Device and or procedure related adverse cardiac events through 1-month post implant;
    • New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min) through 1-month post implant

  2. Change in supine exercise pulmonary capillary wedge pressure (PCWP)

    Time frame: 1 Month Post Implant

    Change in supine exercise pulmonary capillary wedge pressure (PCWP), as assessed by an independent blinded hemodynamic core laboratory, across the four values measured at each visit (values at 20W, 40W, 60W and 80W).

Secondary outcomes

  1. Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline

    Time frame: 1 Month

  2. Cardiovascular death

    Time frame: 12 Months

  3. Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF

    Time frame: 12 Months

  4. Change in Quality Of Life Questionnaire (EQ-5D)

    Time frame: 12 Months

  5. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score)

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Corvia Medical

Industry

Registry information

Official study title

REDUCE LAP-HF RANDOMIZED TRIAL I: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

Important dates

Study start
2015
Primary completion
2016
Study completion
2026
First posted
Nov 9, 2015
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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