Heart FailureALIVE-EANCT05710042
ALIVE Expended Access - Clinical Study
A study testing Revivent TC System in people with Heart Failure and Left Ventricle Remodeling, run by BioVentrix at 2 sites in United States.
Trial summary
A prospective, multi-center, single-arm study. This study will enroll a maximum of 35 subjects treated with the Revivent TC System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Ventricle Remodeling
- What is being tested?
- Revivent TC System
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 18 years old or older;
- LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) scar;
- LV Aneurysm/Scar Location: Defined as a scar involving septum and/or anterior, apical or anterolateral regions of the left ventricle as evidenced by cardiac imaging and referred for surgical management;
- Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging;
- Left Ventricular Ejection Fraction < 45%;
- Left ventricular end-systolic volume index ≥50 mL/m2;
Show all 12Show fewer
- Suffering from heart failure symptoms as defined by NYHA Classification > 2 not responsive to medical therapy;
- Patient completed 6 Minute Walk Test and MLHF Quality of Life Questionnaire (can be performed at baseline visit);
- Patient is on adequate Guideline Directed Medical Therapy (GDMT);
- Subject or a legally authorized representative must provide written informed consent;
- Agree to required follow-up visits; and
- Female subject of childbearing potential does not plan pregnancy for at least one year following the index procedure. For a female of childbearing potential, a pregnancy test must be performed with negative results known within seven days prior to index procedure.
Who cannot join
- Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 60 days prior to enrollment;
- Valvular heart disease, which in the opinion of the investigator, will require surgery;
- Functional Mitral Regurgitation greater than moderate (i.e. EROA>20mm sq.) and primary MR (including MR due to papillary muscle rupture);
- Need for coronary revascularization, in the opinion of the site investigator;
- Peak Systolic Pulmonary Arterial Pressure > 60 mm Hg via echo or right heart catheterization and/or evidence of cor pulmonale;
- Myocardial Infarction within 90 days prior to enrollment;
Show all 20Show fewer
- Within the last six months, a prior CVA or TIA, or any intracranial hemorrhage, or any permanent neurologic deficit, or any known intracranial pathology;
- Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission;
- Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac; Page 6 of 64 BioVentrix CIP-0067, Rev A
- Chronic renal failure with a serum creatinine >2.5 mg/dL and/or GFR<30ml/min;
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- Presence of significant ventricular arrhythmias
- Contraindication or inability to adhere to systemic anticoagulation;
- Known hypersensitivity or contraindication to device materials;
- Previous pericardiotomy or left thoracotomy;
- Pathology/previous surgery/radiation therapy of the right neck that would interfere with placement of a 14F delivery catheter;
- Prior open heart surgery or significant pericarditis;
- Calcified ventricular wall in the area of intended anchor implants as verified by cardiac imaging;
- Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by cardiac imaging that has not been adequately treated with anticoagulant.
- Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms ALIVE-EA (American Less Invasive Ventricular Enhancement-Expanded Access)
A prospective, multi-center, single-arm study. This study will enroll a maximum of 35 subjects treated with the Revivent TC System.
Read the detailed description
The purpose of this study is to allow the continued use of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure while the pivotal trial for the BioVentrix Revivent TC System is continuing through the follow up phase and the PMA documentation is prepared and reviewed by FDA.
- Conditions
- Heart Failure, Left Ventricle Remodeling
- Being tested
- Revivent TC System
- Keywords
- Heart Failure, Left Ventricular Remodeling
- Medical subject headings
- Heart Failure, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revivent TC SystemDevice
The Revivent TC System is indicated for patients suffering from symptomatic heart failure referred for treatment of left ventricular antero-septal aneurysms/scars that are contiguous and includes both anterior and septal components.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- BioVentrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg W Stone, MD, Principal investigator, Icahn School of Medicine at Mount Sinai, New York, NYJerry Estep, MD, Principal investigator, Cleveland Clinic Florida, Weston, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710042
- Sponsor's protocol ID
- CIP-0067
- Acronym
- ALIVE-EA
- Status last verified
- Apr 2025
- First submitted
- 24 Jan 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms ALIVE-EA (American Less Invasive Ventricular Enhancement-Expanded Access)
- ClinicalTrials.gov ID
- NCT05710042
- Acronym / sponsor ID
- ALIVE-EA / CIP-0067
- Conditions
- Heart Failure, Left Ventricle Remodeling
- Keywords
- Heart Failure, Left Ventricular Remodeling
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- BioVentrixIndustry (pharma, biotech, devices)
- First posted
- 2 Feb 2023 (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.
A prospective, multi-center, single-arm study. This study will enroll a maximum of 35 subjects treated with the Revivent TC System.
Detailed description
The purpose of this study is to allow the continued use of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure while the pivotal trial for the BioVentrix Revivent TC System is continuing through the follow up phase and the PMA documentation is prepared and reviewed by FDA.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 years old or older;
- LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) scar;
- LV Aneurysm/Scar Location: Defined as a scar involving septum and/or anterior, apical or anterolateral regions of the left ventricle as evidenced by cardiac imaging and referred for surgical management;
- Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging;
- Left Ventricular Ejection Fraction < 45%;
Key exclusion criteria (20 listed)
- Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 60 days prior to enrollment;
- Valvular heart disease, which in the opinion of the investigator, will require surgery;
- Functional Mitral Regurgitation greater than moderate (i.e. EROA>20mm sq.) and primary MR (including MR due to papillary muscle rupture);
- Need for coronary revascularization, in the opinion of the site investigator;
- Peak Systolic Pulmonary Arterial Pressure > 60 mm Hg via echo or right heart catheterization and/or evidence of cor pulmonale;
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 |
|---|---|---|
| Revivent TC SystemThe Revivent TC System is indicated for patients suffering from symptomatic heart failure referred for treatment of left ventricular antero-septal aneurysms/scars that are contiguous and includes both anterior and septal components. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Related trials for Heart Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
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.
Gregg W Stone, MD principal investigator
Icahn School of Medicine at Mount Sinai, New York, NY
Jerry Estep, MD principal investigator
Cleveland Clinic Florida, Weston, FL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revivent TC System in people with Heart Failure and Left Ventricle Remodeling, run by BioVentrix at 2 sites in United States.
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 12 inclusion and 20 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 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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 10 Apr 2025.