Heart FailureNCT04781660
First in Man Study of Implantable Alginate Hydrogel
A study testing Implantable Alginate Hydrogel in people with Heart Failure, run by Xijing Hospital at 1 site in China.
Trial summary
The objective of this clinical research is to evaluate the safety and effectiveness of Implantable Alginate Hydrogel to reconstruct the left ventricle in the treatment of heart failure Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Implantable Alginate Hydrogel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Jan 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients must have been able and willing to give written informed consent
- The patients should be adult (age≥ 18 years and <75 years) males or females
- The patients must have been on stable, evidence-based therapy for HF
- The Patients have a LVEF ≤35%
- NYHA is classified as grade III or IV
- If female, the patients must have been (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of the study device.
Who cannot join
- Have undergone any therapeutic traumatic heart surgery within 30 days.
- Hemodynamic instability or cardiogenic shock.
- Right-sided HF.
- Patients who presented with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis.
- History of Constrictive pericarditis.
- History of stroke (within 60 days prior to the surgical procedure).
Show all 13Show fewer
- History of myocardial infarction (within 30 days prior to the surgical procedure).
- An LV wall thickness of the LV free-wall, at the mid-ventricular level, of < 6 mm.
- Serum creatinine > 2.0 mg/dL, or calculate creatinine clearance rate <25 mL/min
- Clinically significant liver enzyme abnormalities, i.e., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2 times the upper limit of normal and/or bilirubin more than 50% above the upper limit of normal.
- Had been receiving concurrently an investigational product in another clinical trial or had received an investigational product in another clinical trial in the 30 days prior to enrollment.
- A life expectancy of < 1 year due to comorbidities .
- Unfit for the minimal invasive treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Air Force Military Medical University
Xi’an, Shanxi
About this study
Official title: A Clinical Research for Safety and Feasibility of Implantable Alginate Hydrogel as a Method of Left Ventricular Restoration in Patients With Heart Failure
The objective of this clinical research is to evaluate the safety and effectiveness of Implantable Alginate Hydrogel to reconstruct the left ventricle in the treatment of heart failure
- Conditions
- Heart Failure
- Being tested
- Implantable Alginate Hydrogel
- Keywords
- caused by ischemic cardiomyopathy, caused by non-ischemic cardiomyopathy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Alginate HydrogelDevice
Implantable Alginate Hydrogel is a single use, multiple component device. It is expected to be used as a space-occupying material implanted into the myocardium to affect the shape of the left ventricle and reduce the clinical symptoms of patients with left ventricular ischemia and non-ischemic cardiomyopathy.
The hydrogel serves as an artificial myocardial filler to stop the continuous expansion of the ventricle and restore it to a more favorable shape and size. The expected clinical effect of the Implanted Alginate Hydrogel is to reduce the clinical symptoms of patients and improve the quality of life by improving the structure and function of the failing heart.
| Study group | Role | What they receive |
|---|---|---|
| Implantable Alginate Hydrogel | Experimental | All patients will be treated with Implantable Alginate Hydrogel Receives: Device: Implantable Alginate Hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Serious Adverse Device Events
Definition of SADE: Any complications related to the device include but not limited: death, stroke, permanent damage to the heart, any situation that requires further intervention, etc.
Measured: 30 days after implantation
Secondary outcomes (7)
Device successfully Setup rate
Device successfully Setup defined as:
- The device reaches the expected implant location
- Implant the hydrogel accurately in the left ventricle wall for 6~12 implant points.
- Remove the delivery system
Measured: immediately after the implantation
Incidence of SAE
Rate of Serious Adverse Events occurred during procedure and follow-up
Measured: Within 6 months after implantation
NHYA Class level changes rate between baseline and 6 months' follow-up
Measured: 6 months after implantation
Quality of life changes rate between baseline and 6 months' follow-up
Measured: 6 months after implantation
Rate of Rehospitalization due to heart failure
Rehospitalization due to heart failure within 6 months after implantation
Measured: within 6 months after implantation
LVEF changes rate between baseline and 6 months' follow-up
Measured: 6 months after implantation
Size of LV changes rate between baseline and 6 months' follow-up
Measured: 6 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Jan 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.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ling Tao, Professor, Principal investigator, The First Affiliated Hospital of Air Force Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781660
- Sponsor's protocol ID
- DK/CQ/CM-001-CIP-01
- Status last verified
- Feb 2021
- First submitted
- 1 Mar 2021
- Last updated
- 4 Mar 2021
- Results posted
- 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 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research for Safety and Feasibility of Implantable Alginate Hydrogel as a Method of Left Ventricular Restoration in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT04781660
- Acronym / sponsor ID
- DK/CQ/CM-001-CIP-01
- Conditions
- Heart Failure
- Keywords
- caused by ischemic cardiomyopathy, caused by non-ischemic cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 4 Mar 2021 (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 clinical research is to evaluate the safety and effectiveness of Implantable Alginate Hydrogel to reconstruct the left ventricle in the treatment of heart failure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable Alginate Hydrogel | Experimental | Device: Implantable Alginate HydrogelAll patients will be treated with Implantable Alginate Hydrogel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patients must have been able and willing to give written informed consent
- The patients should be adult (age≥ 18 years and <75 years) males or females
- The patients must have been on stable, evidence-based therapy for HF
- The Patients have a LVEF ≤35%
- NYHA is classified as grade III or IV
Key exclusion criteria (13 listed)
- Have undergone any therapeutic traumatic heart surgery within 30 days.
- Hemodynamic instability or cardiogenic shock.
- Right-sided HF.
- Patients who presented with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis.
- History of Constrictive pericarditis.
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 |
|---|---|---|
| Implantable Alginate HydrogelImplantable Alginate Hydrogel is a single use, multiple component device. It is expected to be used as a space-occupying material implanted into the myocardium to affect the shape of the left ventricle and reduce the clinical symptoms of patients with left ventricular ischemia and non-ischemic cardiomyopathy. The hydrogel serves as an artificial myocardial filler to stop the continuous expansion of the ventricle and restore it to a more favorable shape and size. The expected clinical effect of the Implanted Alginate Hydrogel is to reduce the clinical symptoms of patients and improve the quality of life by improving the structure and function of the failing heart. | Device | Implantable Alginate Hydrogel |
Primary outcome
Rate of Serious Adverse Device Events
Time frame: 30 days after implantation
Definition of SADE: Any complications related to the device include but not limited: death, stroke, permanent damage to the heart, any situation that requires further intervention, etc.
7 secondary outcomes
Device successfully Setup rate
Time frame: immediately after the implantation
Incidence of SAE
Time frame: Within 6 months after implantation
NHYA Class level changes rate between baseline and 6 months' follow-up
Time frame: 6 months after implantation
Quality of life changes rate between baseline and 6 months' follow-up
Time frame: 6 months after implantation
Rate of Rehospitalization due to heart failure
Time frame: within 6 months after implantation
LVEF changes rate between baseline and 6 months' follow-up
Time frame: 6 months after implantation
Size of LV changes rate between baseline and 6 months' follow-up
Time frame: 6 months after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- 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.
Ling Tao, Professor principal investigator
The First Affiliated Hospital of Air Force Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Alginate Hydrogel in people with Heart Failure, run by Xijing Hospital at 1 site in China.
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 6 inclusion and 13 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 4 Mar 2021. 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 China. 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?
Rate of Serious Adverse Device Events (time frame: 30 days after implantation). 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 4 Mar 2021.