REDUCE LAP-HF RANDOMIZED TRIAL I
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| ClinicalTrials.gov Identifier: NCT02600234 |
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Recruitment Status :
Active, not recruiting
First Posted : November 9, 2015
Last Update Posted : March 10, 2023
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Sponsor:
Corvia Medical
Information provided by (Responsible Party):
Corvia Medical
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Brief Summary:
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure | Device: Inter-Atrial Shunt Device Other: Intracardiac Echo | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 44 participants |
| 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 |
| Study Start Date : | December 2015 |
| Actual Primary Completion Date : | December 2016 |
| Estimated Study Completion Date : | August 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Failure
| Arm | Intervention/treatment |
|---|---|
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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.
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Device: Inter-Atrial Shunt Device
An implantable device placed in the interatrial septum
Other Name: IASD |
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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.
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Other: Intracardiac Echo
Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage. |
Primary Outcome Measures :
- 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
- 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 Outcome Measures :
- Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline [ Time Frame: 1 Month ]
- Cardiovascular death [ Time Frame: 12 Months ]
- Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF [ Time Frame: 12 Months ]
- Change in Quality Of Life Questionnaire (EQ-5D) [ Time Frame: 12 Months ]
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score) [ Time Frame: 12 Months ]
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| 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
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
Locations
Show 21 study locations
Sponsors and Collaborators
Corvia Medical
Investigators
| Principal Investigator: | Sanjiv Shah, MD | Northwestern University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Corvia Medical |
| ClinicalTrials.gov Identifier: | NCT02600234 |
| Other Study ID Numbers: |
1501 |
| First Posted: | November 9, 2015 Key Record Dates |
| Last Update Posted: | March 10, 2023 |
| Last Verified: | June 2022 |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |