Clinical trial NCT02600234: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Corvia Medical
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE)
timeFrame: 1 Month Post Implant
measure: Change in supine exercise pulmonary capillary wedge pressure (PCWP)
timeFrame: 1 Month Post Implant
Secondary outcomes:
measure: Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline
timeFrame: 1 Month
measure: Cardiovascular death
timeFrame: 12 Months
measure: Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF
timeFrame: 12 Months
measure: Change in Quality Of Life Questionnaire (EQ-5D)
timeFrame: 12 Months
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona College of Medicine
state: Arizona
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: Evanston Northshore Healthcare
state: Illinois
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center/NewYork Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Columbus
country: United States
facility: Ohio Health
state: Ohio
city: Columbus
country: United States
facility: Ohio State University College of Medicine
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Aalst
country: Belgium
facility: OLVZ Aalst
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Glasgow
country: United Kingdom
facility: Golden Jubilee Hospital
Study officials:
affiliation: Northwestern University
name: Sanjiv Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.