Ventricular Dysfunction, LeftNCT02931240
BioVentrix Revivent TC™ System Clinical Study
A study testing Revivent TC in people with Ventricular Dysfunction, Left, run by BioVentrix at 30 sites in 4 countries.
Trial summary
A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in an active control… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ventricular Dysfunction, Left
- What is being tested?
- Revivent TC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 29 Aug 2017to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- 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;
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- 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 Candidates for the study group must meet ALL of the inclusion criteria.
- Candidates allocated to active concurrent control pool of patients must meet all inclusion criteria (including LV Aneurysm/Scar Presence), WITH THE EXCEPTION OF ONE OF THE FOLLOWING:
- They have undergone previous pericardiotomy, left thoracotomy, or open heart surgery, or
- The LV Aneurysm/Scar location does not permit treatment with the study device, or
- The patient elects to be enrolled in the control group
Who cannot join
- Candidates will be excluded from the study and active concurrent control group if ANY of the following conditions are present:
- 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 degenerative 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;
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- Myocardial Infarction within 90 days prior to enrollment;
- 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;
- 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
- The following exclusion criteria apply only to the treatment group and do not apply to the concurrent control cohort:
- 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
30 sites in 4 countries.
30 sites in 4 countries
United States25 sites
University of Michigan
Ann Arbor, Michigan, 48109-5856
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
Hackensack University Medical Center
Hackensack, New Jersey, 07601
UPMC Pinnacle
Harrisburg, Pennsylvania, 17101
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Terrebonne General Medical Center
Houma, Louisiana, 70360
CHI St. Luke's Health-Baylor St. Luke's Medical Center
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Ronald Regan UCLA Medical Center
Los Angeles, California, 90024
WellStar Health System
Marietta, Georgia, 30060
Baptist Hospital of Maimi
Miami, Florida, 33176
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Mount Sinai Hospital
New York, New York, 10029
New York Presbyterian Hospital
New York, New York, 10065
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute
Phoenix, Arizona, 85004
University of California, San Francisco
San Francisco, California, 94143
Memorial Medical Center
Springfield, Illinois, 62781
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
Winchester Medical Center
Winchester, Virginia, 22601
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, 27157
Greece2 sites
Hygeia Hospital
Athens, 151 23
Interbalkan Medical Center
Thessaloniki
United Kingdom2 sites
Papworth Hospital NHS Foundation Trust
Cambridge, CB23 3RE
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
About this study
Official title: Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)
A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in an active control group.
Read the detailed description
The Revivent TC System is indicated for patients referred for surgical treatment of left ventricular scar that is contiguous, and includes both anterior and septal components. Primary and Secondary Effectiveness Endpoints will compare data from the patients treated with the Revivent TC System to a control pool of patients who comply with all aspects of the protocol except scar location and are not treated with the investigational devices but remain on Guideline Directed Medical Therapy (GDMT). The primary safety and effectiveness endpoints will be evaluated at 12 months post procedure. The study will be conducted at a maximum of 20 clinical centers.
- Conditions
- Ventricular Dysfunction, Left
- Being tested
- Revivent TC
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revivent TCDevice
Treatment of LV scar
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the Revivent TC System Receives: Device: Revivent TC |
| Control Pool | No intervention | Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all cause death, mechanical support, emergent cardiac surgery, prolonged mechanical ventilation, renal failure and clinically important stroke compared to data from the STS database for surgical LV aneurysm repair.
Composite primary safety endpoint of all cause death, placement of a mechanical support device intra or post-op (IABP, VAD, ECMO or catheter based), emergent cardiac surgery including reoperation for bleeding or tamponade, prolonged mechanical ventilation, renal failure and clinically important stroke (Rankin Score of 4 or higher) through 30-days post procedure. Data from the patients treated with the Revivent TC System will be compared to surgical outcomes data from the Society for Thoracic Surgery database for surgical LV aneurysm repair.
Measured: 1 Month
The rate of all cause of death, mechanical support, and operation (or re-operation) for HF, bleeding or tamponade from 1 through 12 months post procedure compared to untreated patients who remain on Guideline Directed Medical Therapy (GDMT).
A composite of all cause of death, placement of a mechanical support device and operation (or re-operation) for HF, bleeding or tamponade from 1 through 12 months (day 31 through 365) post procedure. Data from patients treated with the Revivent TC System will be compared to data from a control pool of patients who comply with all aspects of the protocol except scar (aneurysm) location and are not treated with the investigational devices remain on Guideline Directed Medical Therapy (GDMT). Patients in the GDMT group will be evaluated from day 31 through 365 after the date of enrollment into the study.
Measured: 1 Year
Secondary outcomes (1)
The rate of re-hospitalization and improvement of HF Symptoms in patients treated with the test device compared to patients who are maintained on Guideline Directed Medical Therapy.
Composite primary effectiveness endpoint consisting of:
- No hospital readmission for new or worsening heart failure, and
- Improvement in MLHF Quality of Life score by >10 points, and
- Improvement in 6 Minute Walk Distance by >25 meters, and
- Improvement in NYHA Classification > 1 grade.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start29 Aug 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular Dysfunction, LeftStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioVentrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew S Wechsler, MD, Principal investigator, Drexel University College of MedicineGregg W Stone, MD, Principal investigator, Icahn School of Medicine at Mount SinaiJerry D Estep, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931240
- Sponsor's protocol ID
- CIP-0066
- Status last verified
- Aug 2023
- First submitted
- 30 Sep 2016
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Estep JD, Ben-Yehuda O, Wechsler AS, Puri R, Kao AC, Heimes JK, Pfeiffer MP, Boehmer JP, Ninios V, Zaman A, Stone GW. Transcatheter Left Ventricular Reconstruction in Heart Failure Patients With Prior Anterior Myocardial Infarction: The Prospective ALIVE Trial. JACC Heart Fail. 2025 Feb;13(2):296-308. doi: 10.1016/j.jchf.2024.09.023. Epub 2025 Jan 8.
PubMed 39797846
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. 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)
- ClinicalTrials.gov ID
- NCT02931240
- Acronym / sponsor ID
- CIP-0066
- Conditions
- Ventricular Dysfunction, Left
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- BioVentrixIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- 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, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in an active control group.
Detailed description
The Revivent TC System is indicated for patients referred for surgical treatment of left ventricular scar that is contiguous, and includes both anterior and septal components. Primary and Secondary Effectiveness Endpoints will compare data from the patients treated with the Revivent TC System to a control pool of patients who comply with all aspects of the protocol except scar location and are not treated with the investigational devices but remain on Guideline Directed Medical Therapy (GDMT). The primary safety and effectiveness endpoints will be evaluated at 12 months post procedure. The study will be conducted at a maximum of 20 clinical centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Revivent TCTreatment with the Revivent TC System |
| Control Pool | No intervention | –Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 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 (22 listed)
- Candidates will be excluded from the study and active concurrent control group if ANY of the following conditions are present:
- 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 degenerative MR (including MR due to papillary muscle rupture);
- Need for coronary revascularization, in the opinion of the site investigator;
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 TCTreatment of LV scar | Device | Treatment |
Primary outcome
Incidence of all cause death, mechanical support, emergent cardiac surgery, prolonged mechanical ventilation, renal failure and clinically important stroke compared to data from the STS database for surgical LV aneurysm repair.
Time frame: 1 Month
Composite primary safety endpoint of all cause death, placement of a mechanical support device intra or post-op (IABP, VAD, ECMO or catheter based), emergent cardiac surgery including reoperation for bleeding or tamponade, prolonged mechanical ventilation, renal failure and clinically important stroke (Rankin Score of 4 or higher) through 30-days post procedure. Data from the patients treated with the Revivent TC System will be compared to surgical outcomes data from the Society for Thoracic Surgery database for surgical LV aneurysm repair.
The rate of all cause of death, mechanical support, and operation (or re-operation) for HF, bleeding or tamponade from 1 through 12 months post procedure compared to untreated patients who remain on Guideline Directed Medical Therapy (GDMT).
Time frame: 1 Year
A composite of all cause of death, placement of a mechanical support device and operation (or re-operation) for HF, bleeding or tamponade from 1 through 12 months (day 31 through 365) post procedure. Data from patients treated with the Revivent TC System will be compared to data from a control pool of patients who comply with all aspects of the protocol except scar (aneurysm) location and are not treated with the investigational devices remain on Guideline Directed Medical Therapy (GDMT). Patients in the GDMT group will be evaluated from day 31 through 365 after the date of enrollment into the study.
1 secondary outcome
The rate of re-hospitalization and improvement of HF Symptoms in patients treated with the test device compared to patients who are maintained on Guideline Directed Medical Therapy.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 39797846Estep JD, Ben-Yehuda O, Wechsler AS, Puri R, Kao AC, Heimes JK, Pfeiffer MP, Boehmer JP, Ninios V, Zaman A, Stone GW. Transcatheter Left Ventricular Reconstruction in Heart Failure Patients With Prior Anterior Myocardial Infarction: The Prospective ALIVE Trial. JACC Heart Fail. 2025 Feb;13(2):296-308. doi: 10.1016/j.jchf.2024.09.023. Epub 2025 Jan 8.
- Sponsor Web SiteLink provided by the sponsor.
- 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.
Andrew S Wechsler, MD principal investigator
Drexel University College of Medicine
Gregg W Stone, MD principal investigator
Icahn School of Medicine at Mount Sinai
Jerry D Estep, MD principal investigator
The Cleveland Clinic
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revivent TC in people with Ventricular Dysfunction, Left, run by BioVentrix at 30 sites in 4 countries.
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 16 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Greece, United Kingdom, Czechia. 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?
This study is still under way. Results are not available in the source record yet.
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 all cause death, mechanical support, emergent cardiac surgery, prolonged mechanical ventilation, renal failure and clinically important stroke compared to data from the STS database for surgical LV aneurysm repair. (time frame: 1 Month). The study lists 2 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 NCT02931240, which also lists 1 linked publication.
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 22 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.