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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03093961




Registration number
NCT03093961
Ethics application status
Date submitted
15/03/2017
Date registered
28/03/2017
Date last updated
17/04/2019

Titles & IDs
Public title
REDUCE LAP-HFREF TRIAL
Scientific 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
Secondary ID [1] 0 0
1502
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - IASD implant

Experimental: Intervention - IASD Implantation


Treatment: Devices: IASD implant
Single arm for implant

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
The percent of subjects who have successful device implantation - Deployment at the intended location during the index procedure
Timepoint [2] 0 0
Index Procedure
Primary outcome [3] 0 0
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 echo-cardiographic core laboratory
Timepoint [3] 0 0
6 months

Eligibility
Key inclusion criteria
1. Chronic symptomatic Heart Failure (HF) documented by the following:

1. 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

2. 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

2. 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

3. Age = 18 years old

4. Reduced Left ventricular ejection fraction between 20% and 40% as documented by
echocardiography, radio nuclide ventriculography, or MRI within the past 3 months

5. Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP)
documented by:

a. Resting end expiratory PCWP = 18 mmHg, and greater than RAP by = 5 mmHg

6. 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

7. Subject is willing to comply with clinical investigation procedures and agrees to
return for all required follow-up visits, tests, and exams
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are not receiving GDMT for specified reasons

2. NT-Pro BNP < 100 pmol/L (if in sinus rhythm), or <300 pmol/L (if in atrial
fibrillation)

3. Myocardial infarction (MI) and/or percutaneous cardiac intervention within past 3
months; CABG in past 3 months, or current indication for coronary revascularization

4. Cardiac Resynchronization Therapy initiated within the past 3 months

5. Automated Implantable Cardioverter Defibrillator (AICD) placed within past 3 months

6. Severe heart failure defined by all of the following:

1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;

2. Cardiac Index < 2.0 L/min/m2

3. Requiring inotropic infusion (continuous or intermittent) within the past 3
months.

4. Listed on transplant waiting list

7. Ability to perform the 6 minute walk Test >600m

8. Known clinically significant un-revascularized coronary artery disease, defined as:
epi-cardial coronary artery stenosis associated with angina or other evidence of
coronary ischemia.

9. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or
pulmonary emboli within the past 6 months or recurrent DVT/pulmonary emboli

10. Presence of significant valve disease defined by echocardiography as:

1. Mitral valve regurgitation defined as grade > 2+ MR

2. Tricuspid valve regurgitation defined as grade > 2+ TR;

3. Aortic valve disease defined as = 2+ AR or moderate AS

11. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin
analogue; or has a documented coagulopathy

12. Atrial fibrillation with resting HR > 100 BPM

13. Arterial Oxygen saturation < 95% on room air

14. Significant hepatic impairment defined as 3X upper limit of normal of transaminases,
total bilirubin, or alkaline phosphatase; Hepatic cirrhosis; Hypoalbuminemia

15. Resting RAP > 14 mmHg

16. Right ventricular dysfunction, defined as

1. More than mild RV dysfunction as determined by TTE: OR

2. TAPSE < 1.4 cm: OR

3. RV volume = LV volume on echo estimate; OR

4. Evidence of RV dysfunction defined by echo as an RV fractional area change < 35%

17. Evidence of pulmonary hypertension with PVR =4 Woods Units

18. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic
pulmonary disease defined as FEV1 <1L.

19. Currently participating in an investigational drug or device study that may interfere
with the conduct and outcome of this study.

20. Life expectancy less than 12 months for non-cardiovascular reasons

21. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation

22. Known or suspected allergy to nickel

23. Women of child bearing potential

24. Currently requiring dialysis; or e-GFR <25ml/min

25. Systolic blood pressure >170 mmHg despite appropriate medical management

26. Subjects with existing Atrial Septal Defects. Subjects with a Patent Foramen Ovale
(PFO), who have elevated filling pressure despite the PFO are allowed

27. Subjects on immunosuppression or systemic steroid treatment

28. In the opinion of the investigator, the subject is not an appropriate candidate for
the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincent Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Czechia
State/province [2] 0 0
Prague

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Corvia Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/show/NCT03093961
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jan Komtebedde, DVM
Address 0 0
Corvia Medical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jan Komtebedde, DVM
Address 0 0
Country 0 0
Phone 0 0
9786546113
Fax 0 0
Email 0 0
jkomtebedde@corviamedical.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03093961