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REDUCE LAP-HF RANDOMIZED TRIAL I

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02600234
First Posted: November 9, 2015
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Corvia Medical
  Purpose
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

Condition Intervention
Heart Failure Device: Inter-Atrial Shunt Device Other: Intracardiac Echo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Corvia Medical:

Primary Outcome Measures:
  • The change in supine exercise PCWP from baseline [ Time Frame: 1 Month Post Procedure ]
  • The composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal events (MACCRE) [ Time Frame: 1 Month Post Procedure ]

Enrollment: 44
Study Start Date: December 2015
Estimated Study Completion Date: December 2022
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with Inter-Atrial Shunt Device
Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.
Device: Inter-Atrial Shunt Device
An implantable device placed in the interatrial septum
Other Name: IASD
Placebo Comparator: Control
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.
Other: Intracardiac Echo
Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600234


  Show 28 Study Locations
Sponsors and Collaborators
Corvia Medical
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corvia Medical
ClinicalTrials.gov Identifier: NCT02600234     History of Changes
Other Study ID Numbers: 1501
First Submitted: November 5, 2015
First Posted: November 9, 2015
Last Update Posted: August 23, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases