Heart FailureEASE HFNCT05403372
Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
A study testing PAS-C System in people with Heart Failure, run by InterShunt Technologies, Inc. at 1 site in Georgia.
Trial summary
This is a prospective, single arm feasibility study to establish safety and performance of the PAS-C System in subjects with heart failure and elevated left atrial pressure. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- PAS-C System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGeorgia
- Study dates
- 7 May 2022to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented chronic, symptomatic heart failure and NYHA Class II, Class III or ambulatory Class IV at the time of screening visit and receiving guideline directed medical therapy.
- At least one hospitalization or emergency department visit with heart failure as the primary or secondary diagnosis or intravenous diuretic treatment for heart failure or documentation of elevated BNP.
- LVEF ≥ 40%.
- Echocardiographic evidence of diastolic dysfunction during the baseline echocardiography:
- Per baseline exercise right heart catheterization, site measured elevated left atrial pressure with a gradient compared to right atrial pressure.
Who cannot join
- Stroke or thromboembolic event in the past 6 months.
- Severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 2.0 L/min/m2, LVEDD > 6 cm, or received inotropic therapy for LVEF less than 40% within 6 months prior to enrollment.
- Any of the following within 3 months prior to enrollment: myocardial infarction, percutaneous cardiac intervention, CABG, cardiac resynchronization therapy, AICD, or indicated for coronary revascularization at the time of enrollment.
- More than moderate valve disease (mitral, tricuspid, aortic) at the time of enrollment.
- Chronic pulmonary disease requiring continuous home oxygen or hospitalization within prior 12 months for pulmonary disease.
- BMI > 40.
Show all 10Show fewer
- 6-minute Walk Test distance less than 100 m or greater than 450 m performed during baseline screening, or unable to perform baseline bicycle exercise test.
- Any of the following at the time of baseline screening: moderate or worse right heart dysfunction, requires dialysis, atrial fibrillation with ventricular rate > 100 bpm, systolic blood pressure greater than 170 mmHg (average of 3 measurements at baseline).
- Evidence of precapillary pulmonary hypertension defined as PVR > 2 Wood units at rest, TPG > 15 at rest or with exercise, resting RA > 15 mmHg, or RA to PCWP ratio > 0.7 at rest and with exercise.
- Anatomic anomaly that precludes creation of interatrial shunt.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, single arm feasibility study to establish safety and performance of the PAS-C System in subjects with heart failure and elevated left atrial pressure.
- Conditions
- Heart Failure
- Being tested
- PAS-C System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAS-C SystemDevice
The InterShunt PAS-C System is a transcatheter system that creates a shunt by excising tissue from the interatrial septum resulting in a left to right atrial shunt that off-loads elevated left atrial pressure, potentially reducing symptoms and improving quality of life. The PAS-C System does not require a permanent implant to maintain patency of the interatrial shunt.
| Study group | Role | What they receive |
|---|---|---|
| InterShunt PAS-C | Experimental | Not described Receives: Device: PAS-C System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization.
The proportion of subjects who experience a composite MACCE or systemic embolization event.
Measured: 1 month
Secondary outcomes (1)
Echocardiogram evidence of interatrial shunt with left to right atrial flow
Proportion of subjects with visible shunt demonstrating left to right atrial flow as determined by echocardiographer
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start7 May 2022
- Primary completion6 Aug 2022
- Study completionAug 2023 (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 (actual)
Sponsor and investigators
- Lead sponsor
- InterShunt Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403372
- Sponsor's protocol ID
- 21-004
- Acronym
- EASE HF
- Status last verified
- Feb 2023
- First submitted
- 24 May 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
- ClinicalTrials.gov ID
- NCT05403372
- Acronym / sponsor ID
- EASE HF / 21-004
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- InterShunt Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 May 2022 (actual)
- Primary completion
- 6 Aug 2022 (actual)
- Study completion
- Aug 2023 (estimated)
- First posted
- 3 Jun 2022 (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.
This is a prospective, single arm feasibility study to establish safety and performance of the PAS-C System in subjects with heart failure and elevated left atrial pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InterShunt PAS-C | Experimental | Device: PAS-C System |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented chronic, symptomatic heart failure and NYHA Class II, Class III or ambulatory Class IV at the time of screening visit and receiving guideline directed medical therapy.
- At least one hospitalization or emergency department visit with heart failure as the primary or secondary diagnosis or intravenous diuretic treatment for heart failure or documentation of elevated BNP.
- LVEF ≥ 40%.
- Echocardiographic evidence of diastolic dysfunction during the baseline echocardiography:
- Per baseline exercise right heart catheterization, site measured elevated left atrial pressure with a gradient compared to right atrial pressure.
Key exclusion criteria (10 listed)
- Stroke or thromboembolic event in the past 6 months.
- Severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 2.0 L/min/m2, LVEDD > 6 cm, or received inotropic therapy for LVEF less than 40% within 6 months prior to enrollment.
- Any of the following within 3 months prior to enrollment: myocardial infarction, percutaneous cardiac intervention, CABG, cardiac resynchronization therapy, AICD, or indicated for coronary revascularization at the time of enrollment.
- More than moderate valve disease (mitral, tricuspid, aortic) at the time of enrollment.
- Chronic pulmonary disease requiring continuous home oxygen or hospitalization within prior 12 months for pulmonary disease.
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 |
|---|---|---|
| PAS-C SystemThe InterShunt PAS-C System is a transcatheter system that creates a shunt by excising tissue from the interatrial septum resulting in a left to right atrial shunt that off-loads elevated left atrial pressure, potentially reducing symptoms and improving quality of life. The PAS-C System does not require a permanent implant to maintain patency of the interatrial shunt. | Device | InterShunt PAS-C |
Primary outcome
The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization.
Time frame: 1 month
The proportion of subjects who experience a composite MACCE or systemic embolization event.
1 secondary outcome
Echocardiogram evidence of interatrial shunt with left to right atrial flow
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAS-C System in people with Heart Failure, run by InterShunt Technologies, Inc. at 1 site in Georgia.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. 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?
Results are not available in the source record.
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 proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization. (time frame: 1 month). 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 1 Mar 2023.