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Heart Failure With Preserved Ejection FractionNCT04632160

Extended IASD Investigation: REDUCE LAP-HF IV

A study testing IASD System II in people with Heart Failure With Preserved Ejection Fraction and Heart Failure With Mid Range Ejection Fraction, run by Corvia Medical.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Multicenter, Prospective, Open Label, Single Arm, Clinical Trial. The primary objective of this clinical trial is to further evaluate the safety and clinical efficacy of the IASD System II in symptomatic heart failure patients with an left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling… Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
IASD System II
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Dec 2021to 1 Jan 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Select Inclusion Criteria:

  • Chronic symptomatic heart failure with preserved or mid-range left ventricular ejection fraction (HFpEF or HFrEF)
  • Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams

Select Exclusion Criteria:

  • Myocardial infarction and/or percutaneous cardiac intervention within past 3 months; Coronary artery bypass surgery in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months
  • Advanced heart failure
  • History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
  • Significant heart valve disease
  • Chronic pulmonary disease
  • Women of childbearing potential
  • Severe obstructive sleep apnea not treated with CPAP or other measures

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

Multicenter, Prospective, Open Label, Single Arm, Clinical Trial.

The primary objective of this clinical trial is to further evaluate the safety and clinical efficacy of the IASD System II in symptomatic heart failure patients with an left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT); and to compare the safety and efficacy results to those from the treatment arm of the REDUCE LAP-HF Randomized Trial II (Corvia protocol 1601).

Read the detailed description

Participants are screened against non-invasive eligibility criteria and scheduled for a hemodynamic evaluation. Following right heart catheterization at rest and during supine bicycle exercise, patients will undergo a brief intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) exam for septal suitability.

Eligible patients continue with, fluoroscopically and echo guided transseptal puncture and IASD System II implant procedure. If a previously unknown protocol exclusion is discovered during the index procedure, and device is not implanted, participant is followed for 30 days, and then exits the study.

Participants return for follow-up exams 30 days after the implant procedure and annually for 5 years after the implant procedure. In-person visits will take place for the first 2 years. Telephone follow-up and medical chart review will be conducted for years 3-5.

Being tested
IASD System II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IASD System IIDevice

    Also called Interatrial Shunt Device

    The implant is placed across the interatrial septum using a percutaneous transcatheter approach.

Study groups in NCT04632160
Study groupRoleWhat they receive
TreatmentExperimentalTreatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure.
Receives: Device: IASD System II

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months

    Measured: 12 Month

  2. Total rate (first plus recurrent) per patient year of heart failure (HF) admissions or healthcare facility visits for IV diuresis for HF up to 24 months, analyzed when the last subject completes 12 month follow-up, and time-to-first HF event

    Measured: Up to 24 Months

  3. Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months

    Measured: 12 Month

Secondary outcomes (10)

  1. Cardiovascular mortality through 12 months

    Measured: 12 Months

  2. Non-fatal, ischemic stroke through 12 months

    Measured: 12 Months

  3. New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min/1.73 m2) through 12 months

    Measured: 12 Months

  4. Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery.

    Measured: 12 Months

  5. Thrombo-embolic complications (TIA, systemic embolization) through 12 months

    Measured: 12 Months

  6. ≥30% increase in right ventricular size/decrease in TAPSE through 12 months

    Measured: 12 Months

  7. Newly acquired persistent or permanent AF or atrial flutter through 12 months

    Measured: 12 Months

  8. Total rate per patient year of heart failure admissions or healthcare facility visits for IV diuresis or visits with intensification of oral diuresis for HF through 24 months, analyzed when the last subject completes 12 months follow-up

    Measured: Up to 24 months

  9. Change in New York Heart Association (NYHA) functional Class between baseline and 12 months

    Measured: 12 Months

  10. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score between baseline and 12 months, categorized as ≤0, >0 - 5, >5 - 10, >10 - 15, >15 - 20, >20 - 25, >25.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Why it stopped: Withdrawn pending formal analysis of REDUCE LAP-HF II Pivotal Study results

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04632160
Sponsor's protocol ID
2001
Status last verified
Jul 2021
First submitted
6 Nov 2020
Last updated
2 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IASD System II in people with Heart Failure With Preserved Ejection Fraction and Heart Failure With Mid Range Ejection Fraction, run by Corvia Medical.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: withdrawn, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months (time frame: 12 Month). 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?

On the ClinicalTrials.gov record for NCT04632160.

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 2 Aug 2021.

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