Heart FailureNCT03093961
REDUCE LAP-HFREF TRIAL
A study testing IASD implant in people with Heart Failure, run by Corvia Medical at 4 sites in 3 countries.
Trial summary
The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- IASD implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 10 Mar 2017to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic symptomatic Heart Failure (HF) documented by the following:
- New York Heart Association (NYHA) Class III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit, and signs (e.g. any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
- One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify), or one emergency department visit with IV treatment for HF within the 12 months prior to study entry
- Ongoing stable GDMT for HF (Class I, and IIa recommendations) according to the 2016 ACC/AHA Guidelines for the management of Heart Failure (with no significant changes [>100% increase or 50% decrease], excluding diuretic dose changes for a minimum of 3 months prior to screening), which is expected to be maintained without change for 6 months
- Age ≥ 18 years old
- Reduced Left ventricular ejection fraction between 20% and 40% as documented by echocardiography, radio nuclide ventriculography, or MRI within the past 3 months
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- Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by:
- Resting end expiratory PCWP ≥ 18 mmHg, and greater than RAP by ≥ 5 mmHg
- Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, as approved by the IRB
- Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
- Trans-septal catheterization by femoral vein access is determined to be feasible
Who cannot join
- Patients who are not receiving GDMT for specified reasons
- NT-Pro BNP < 100 pg/mL (if in sinus rhythm), or <300 pg/mL (if in atrial fibrillation); or BNP < 70 pg/mL (if in sinus rhythm), or < 200 pg/mL (if in atrial fibrillation)
- Myocardial infarction (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 3 months
- Automated Implantable Cardioverter Defibrillator (AICD) placed within past 3 months
- Severe heart failure defined by all of the following:
Show all 39Show fewer
- ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
- Cardiac Index < 2.0 L/min/m2
- Requiring inotropic infusion (continuous or intermittent) within the past 3 months.
- Listed on transplant waiting list
- Ability to perform the 6 minute walk Test >600m
- Known clinically significant un-revascularized coronary artery disease, defined as: epi-cardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
- History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months or recurrent DVT/pulmonary emboli
- Presence of significant valve disease defined by echocardiography as:
- Mitral valve regurgitation defined as grade > 2+ MR
- Tricuspid valve regurgitation defined as grade > 2+ TR;
- Aortic valve disease defined as ≥ 2+ AR or moderate AS
- Subject is contraindicated to receive either dual antiplatelet therapy or warfarin analogue; or has a documented coagulopathy
- Atrial fibrillation with resting HR > 100 BPM
- Arterial Oxygen saturation < 95% on room air
- Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase; Hepatic cirrhosis; Hypoalbuminemia
- Resting RAP > 14 mmHg
- Right ventricular dysfunction, defined as
- More than mild RV dysfunction as determined by TTE: OR
- TAPSE < 1.4 cm: OR
- RV volume ≥ LV volume on echo estimate; OR
- Evidence of RV dysfunction defined by echo as an RV fractional area change < 35%
- Evidence of pulmonary hypertension with PVR ≥4 Woods Units
- Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 <1L.
- Currently participating in an investigational drug or device study that may interfere with the conduct and outcome of this study.
- Life expectancy less than 12 months for non-cardiovascular reasons
- Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
- Known or suspected allergy to nickel
- Women of child bearing potential
- Currently requiring dialysis; or e-GFR <25ml/min
- Systolic blood pressure >170 mmHg despite appropriate medical management
- Subjects with existing or surgically closed (with a patch) Atrial Septal Defects. Subjects with a Patent Foramen Ovale (PFO), who have elevated filling pressure despite the PFO are allowed
- Subjects on immunosuppression or systemic steroid treatment
- In the opinion of the investigator, the subject is not an appropriate candidate for the study
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Australia2 sites
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
St. Vincent Hospital
Sydney
About this study
Official title: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure With Reduced Ejection Fraction
The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT).
Read the detailed description
The intended clinical indication of the IASD System II is the reduction of elevated LAP in patients with symptomatic heart failure with reduced ejection fraction, despite appropriate medical management. The implant is designed with a center barrel opening that, in the setting of elevated LAP, allows left to right flow. Since many of the symptoms these patients experience are believed to be due to elevated LAP, the IASD System II has the potential to significantly reduce symptoms and improve the quality of life in patients with otherwise limited treatment options.
The study design is a prospective, non-randomized, single-arm feasibility trial. This study will implant up to 10 subjects. The population will include heart failure patients with reduced ejection fraction, and elevated left sided filling pressures, who remain symptomatic despite GDMT, including optimal doses of recommended pharmaceutical treatments, surgical, and device intervention(s) (CRT, AICD, reduction of MRI). After analysis of the 1 month results (including baseline and 1 month Core laboratory echocardiographic and hemodynamic data) of the first 5 implanted patients, a decision will be made to implant an additional 5 patients,
- Conditions
- Heart Failure
- Being tested
- IASD implant
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASD implantDevice
Single arm for implant
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | IASD Implantation Receives: Device: IASD implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of subjects who experience major adverse cardiac and/or cerebrovascular events (MACCE)
The primary endpoint will be peri-procedural, and 6 months Major Adverse Cardiac and Cerebrovascular Events (MACCE) and systemic embolic events in patients implanted with the IASD.
Measured: 6 months
The percent of subjects who have successful device implantation
Deployment at the intended location during the index procedure
Measured: Index Procedure
The percent of subjects left to right flow through the device
Left to right flow through the device at 6 months as assessed by an echocardiographic core laboratory
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start10 Mar 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corvia Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Komtebedde, DVM, Study director, Corvia Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093961
- Sponsor's protocol ID
- 1502
- Status last verified
- Feb 2024
- First submitted
- 15 Mar 2017
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT03093961
- Acronym / sponsor ID
- 1502
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Corvia MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT).
Detailed description
The intended clinical indication of the IASD System II is the reduction of elevated LAP in patients with symptomatic heart failure with reduced ejection fraction, despite appropriate medical management. The implant is designed with a center barrel opening that, in the setting of elevated LAP, allows left to right flow. Since many of the symptoms these patients experience are believed to be due to elevated LAP, the IASD System II has the potential to significantly reduce symptoms and improve the quality of life in patients with otherwise limited treatment options.
The study design is a prospective, non-randomized, single-arm feasibility trial. This study will implant up to 10 subjects. The population will include heart failure patients with reduced ejection fraction, and elevated left sided filling pressures, who remain symptomatic despite GDMT, including optimal doses of recommended pharmaceutical treatments, surgical, and device intervention(s) (CRT, AICD, reduction of MRI). After analysis of the 1 month results (including baseline and 1 month Core laboratory echocardiographic and hemodynamic data) of the first 5 implanted patients, a decision will be made to implant an additional 5 patients,
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: IASD implantIASD Implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Chronic symptomatic Heart Failure (HF) documented by the following:
- Ongoing stable GDMT for HF (Class I, and IIa recommendations) according to the 2016 ACC/AHA Guidelines for the management of Heart Failure (with no significant changes [>100% increase or 50% decrease], excluding diuretic dose changes for a minimum of 3 months prior to screening), which is expected to be maintained without change for 6 months
- Age ≥ 18 years old
- Reduced Left ventricular ejection fraction between 20% and 40% as documented by echocardiography, radio nuclide ventriculography, or MRI within the past 3 months
- Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by:
Key exclusion criteria (39 listed)
- Patients who are not receiving GDMT for specified reasons
- NT-Pro BNP < 100 pg/mL (if in sinus rhythm), or <300 pg/mL (if in atrial fibrillation); or BNP < 70 pg/mL (if in sinus rhythm), or < 200 pg/mL (if in atrial fibrillation)
- Myocardial infarction (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 3 months
- Automated Implantable Cardioverter Defibrillator (AICD) placed within past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IASD implantSingle arm for implant | Device | Intervention |
Primary outcome
The percent of subjects who experience major adverse cardiac and/or cerebrovascular events (MACCE)
Time frame: 6 months
The primary endpoint will be peri-procedural, and 6 months Major Adverse Cardiac and Cerebrovascular Events (MACCE) and systemic embolic events in patients implanted with the IASD.
The percent of subjects who have successful device implantation
Time frame: Index Procedure
Deployment at the intended location during the index procedure
The percent of subjects left to right flow through the device
Time frame: 6 months
Left to right flow through the device at 6 months as assessed by an echocardiographic core laboratory
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Komtebedde, DVM study director
Corvia Medical
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASD implant in people with Heart Failure, run by Corvia Medical at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, United States, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent of subjects who experience major adverse cardiac and/or cerebrovascular events (MACCE) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.