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REDUCE LAP-HF RANDOMIZED TRIAL I

Primary Purpose

Heart Failure

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Inter-Atrial Shunt Device
Intracardiac Echo
Sponsored by
Corvia Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona College of Medicine
  • Yale University
  • Northwestern University
  • Evanston Northshore Healthcare
  • Cardiovascular Institute of the South
  • Ochsner Medical Center
  • Massachusetts General Hospital
  • University of Michigan Health System
  • Mayo Clinic
  • Columbia University Medical Center/NewYork Presbyterian Hospital
  • Mt. Sinai Hospital
  • New York University
  • Wake Forest
  • Ohio Health
  • Ohio State University College of Medicine
  • University of Pennsylvania
  • Medical University of South Carolina
  • The Alfred Hospital
  • OLVZ Aalst
  • UMC Groningen
  • Golden Jubilee Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment with Inter-Atrial Shunt Device

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE)
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
Change in supine exercise pulmonary capillary wedge pressure (PCWP)
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 Outcome Measures

Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline
Cardiovascular death
Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF
Change in Quality Of Life Questionnaire (EQ-5D)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score)

Full Information

First Posted
November 5, 2015
Last Updated
March 8, 2023
Sponsor
Corvia Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02600234
Brief Title
REDUCE LAP-HF RANDOMIZED TRIAL I
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corvia Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Inter-Atrial Shunt Device
Arm Type
Experimental
Arm Description
Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Inter-Atrial Shunt Device
Other Intervention Name(s)
IASD
Intervention Description
An implantable device placed in the interatrial septum
Intervention Type
Other
Intervention Name(s)
Intracardiac Echo
Intervention Description
Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.
Primary Outcome Measure Information:
Title
Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE)
Description
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
Time Frame
1 Month Post Implant
Title
Change in supine exercise pulmonary capillary wedge pressure (PCWP)
Description
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).
Time Frame
1 Month Post Implant
Secondary Outcome Measure Information:
Title
Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline
Time Frame
1 Month
Title
Cardiovascular death
Time Frame
12 Months
Title
Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF
Time Frame
12 Months
Title
Change in Quality Of Life Questionnaire (EQ-5D)
Time Frame
12 Months
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score)
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjiv Shah, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona College of Medicine
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Evanston Northshore Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
41809
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Columbia University Medical Center/NewYork Presbyterian Hospital
City
New York
State/Province
New York
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
Country
United States
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Ohio Health
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Ohio State University College of Medicine
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
The Alfred Hospital
City
Melbourne
Country
Australia
Facility Name
OLVZ Aalst
City
Aalst
Country
Belgium
Facility Name
UMC Groningen
City
Groningen
Country
Netherlands
Facility Name
Golden Jubilee Hospital
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31753198
Citation
Obokata M, Reddy YNV, Shah SJ, Kaye DM, Gustafsson F, Hasenfubeta G, Hoendermis E, Litwin SE, Komtebedde J, Lam C, Burkhoff D, Borlaug BA. Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Nov 26;74(21):2539-2550. doi: 10.1016/j.jacc.2019.08.1062.
Results Reference
derived
PubMed Identifier
30167646
Citation
Shah SJ, Feldman T, Ricciardi MJ, Kahwash R, Lilly S, Litwin S, Nielsen CD, van der Harst P, Hoendermis E, Penicka M, Bartunek J, Fail PS, Kaye DM, Walton A, Petrie MC, Walker N, Basuray A, Yakubov S, Hummel SL, Chetcuti S, Forde-McLean R, Herrmann HC, Burkhoff D, Massaro JM, Cleland JGF, Mauri L. One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial: A Randomized Clinical Trial. JAMA Cardiol. 2018 Oct 1;3(10):968-977. doi: 10.1001/jamacardio.2018.2936.
Results Reference
derived
PubMed Identifier
29142012
Citation
Feldman T, Mauri L, Kahwash R, Litwin S, Ricciardi MJ, van der Harst P, Penicka M, Fail PS, Kaye DM, Petrie MC, Basuray A, Hummel SL, Forde-McLean R, Nielsen CD, Lilly S, Massaro JM, Burkhoff D, Shah SJ; REDUCE LAP-HF I Investigators and Study Coordinators. Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]): A Phase 2, Randomized, Sham-Controlled Trial. Circulation. 2018 Jan 23;137(4):364-375. doi: 10.1161/CIRCULATIONAHA.117.032094. Epub 2017 Nov 15.
Results Reference
derived
PubMed Identifier
27330010
Citation
Feldman T, Komtebedde J, Burkhoff D, Massaro J, Maurer MS, Leon MB, Kaye D, Silvestry FE, Cleland JG, Kitzman D, Kubo SH, Van Veldhuisen DJ, Kleber F, Trochu JN, Auricchio A, Gustafsson F, Hasenfubeta G, Ponikowski P, Filippatos G, Mauri L, Shah SJ. Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure: Rationale and Design of the Randomized Trial to REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I). Circ Heart Fail. 2016 Jul;9(7):e003025. doi: 10.1161/CIRCHEARTFAILURE.116.003025.
Results Reference
derived

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REDUCE LAP-HF RANDOMIZED TRIAL I

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