Heart FailurePhase 1ReviventTC1NCT02553785
Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy
A Phase 1 study testing Revivent TC in people with Heart Failure, run by BioVentrix at 1 site in Spain.
Trial summary
This study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix Revivent TransCatheter (TC) System for left ventricular (LV) volume reduction in heart failure (HF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- 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
- 89 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Dec 2019
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80;
- Left Ventricular Ejection Fraction (LVEF) >15% and ≤ 45%;
- New York Heart Association (NYHA) Functional Class II-IV;
- Left Ventricular End Systolic Volume (LVESVI) ≥60 cc/m² but ≤ 120 cc/ m²
- Contiguous acontractile (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) regions of the left ventricle as evidenced by a Cardiac Magnetic Resonance (CMR) or Computed Tomography (CT);
- Maintained standard medical management for at least 90 days, and at stable target (or maximum tolerated) dosages;
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- Willing and competent to complete informed consent;
- Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by CMR or CT;
- Agree to required follow-up visits
Who cannot join
- Calcified ventricular wall in the area of intended scar exclusion as verified by echocardiography or equivalent;
- Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent;
- Cardiac Resynchronization Therapy (CRT) device placement ≤ 60 days prior to enrollment;
- Significant diastolic dysfunction, defined as a pseudo-normal Doppler filling pattern with E/A ratio > 2;
- Thin walled, paradoxically moving septal scar that would preclude successful support of the anchor pairs as evidenced by CMR;
- Cardiac valve disease which, in the opinion of the investigator, will require surgery;
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- Intolerance or unwillingness to take anti-coagulation medication;
- Functioning pacemaker leads in antero-apical right ventricle, which, in the opinion of the investigator, would interfere with anchor placement;
- Pulmonary Arterial Pressure > 60 mm Hg via echo;
- Myocardial Infarction within 90 days prior to enrollment;
- Previous Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) which resulted, in the opinion of the investigator, in a significant residual neurological deficit;
- Aorto iliac disease that would preclude fem-fem bypass.
- Previous right neck surgery, previous pericardiotomy, previous left chest surgery;
- Co-morbid disease process with life expectancy of less than one year;
- Patients with lung, kidney and/or liver transplant;
- Chronic renal failure with a serum creatinine >2 mg/dL;
- Inoperable coronary disease with significant ischemia;
- Pregnant or planning to become pregnant during the study;
- Enrolled in any concurrent study other than observational.
- Previous left thoracotomy
- Pulmonary disease that would preclude single lung ventilation
Trial locations and contacts
1 site in 1 country.
About this study
This study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix Revivent TransCatheter (TC) System for left ventricular (LV) volume reduction in heart failure (HF).
Read the detailed description
The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the feasibility of using the BioVentrix Revivent TC System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.
The objective of this study is to determine the safety and functionality of a device that enables left ventricle (LV) volume and radius reduction through scar exclusion in appropriate patients suffering from systolic HF. Use of this device replicates the geometric reconfiguration of the ventricle achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating heart, and creates the option of eliminating the use of Cardiopulmonary Bypass.
The System utilizes anchors that are implanted into the scarred portion of the heart, rendering the ventricle smaller, and is employed in a cardiac surgical setting without the use of cardiopulmonary bypass. The Revivent TC anchors may be implanted through a sternotomy or through a mini-thoracotomy and jugular access. Eligible subjects will be limited to those whose ventricular dysfunction is due to ischemic cardiomyopathy caused, by a previous (greater than 90 days) myocardial infarction (MI) with acontractile (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region.
- Conditions
- Heart Failure
- Being tested
- Revivent TC
- Keywords
- BioVentrix, Revivent, Revivent TC
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revivent TCDevice
| Study group | Role | What they receive |
|---|---|---|
| Revivent TC | Experimental | Surgical treatment of left ventricle using the Revivent TC System Receives: Device: Revivent TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Overall rate of serious adverse events (SAEs)
Measured: 6 months
Primary Efficacy Endpoint
Decrease in LV volume (left ventricular end-systolic volume index) compared to Baseline
Measured: 6 months
Secondary outcomes (6)
Secondary Safety Endpoint
Rate of Serious Adverse Device Effects
Measured: 6 months
Secondary Efficacy Endpoint
Change in Left Ventricular Ejection Fraction compared to Baseline
Measured: 6 months
Secondary Efficacy Endpoint
Hospital readmission for Heart Failure
Measured: 6 months
Secondary Efficacy Endpoint
Change in NYHA failure class compared to Baseline
Measured: 6 months
Secondary Efficacy Endpoint
Change in a standardized 6-minute corridor walk test compared to Baseline
Measured: 6 months
Secondary Efficacy Endpoint
Change in Quality of Life (QOL) by Minnesota Living with Heart Failure (MLHF) Questionnaire compared to Baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2019
- Study completionDec 2019
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioVentrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553785
- Sponsor's protocol ID
- CIP-0056
- Acronym
- ReviventTC1
- Status last verified
- Mar 2021
- First submitted
- 15 Sep 2015
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the BioVentrix Revivent TC for the Treatment of Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02553785
- Acronym / sponsor ID
- ReviventTC1 / CIP-0056
- Conditions
- Heart Failure
- Keywords
- BioVentrix, Revivent, Revivent TC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- BioVentrixIndustry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Study start
- Jun 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 18 Sep 2015 (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.
This study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix Revivent TransCatheter (TC) System for left ventricular (LV) volume reduction in heart failure (HF).
Detailed description
The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the feasibility of using the BioVentrix Revivent TC System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.
The objective of this study is to determine the safety and functionality of a device that enables left ventricle (LV) volume and radius reduction through scar exclusion in appropriate patients suffering from systolic HF. Use of this device replicates the geometric reconfiguration of the ventricle achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating heart, and creates the option of eliminating the use of Cardiopulmonary Bypass.
The System utilizes anchors that are implanted into the scarred portion of the heart, rendering the ventricle smaller, and is employed in a cardiac surgical setting without the use of cardiopulmonary bypass. The Revivent TC anchors may be implanted through a sternotomy or through a mini-thoracotomy and jugular access. Eligible subjects will be limited to those whose ventricular dysfunction is due to ischemic cardiomyopathy caused, by a previous (greater than 90 days) myocardial infarction (MI) with acontractile (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revivent TC | Experimental | Device: Revivent TCSurgical treatment of left ventricle using the Revivent TC System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 - 80;
- Left Ventricular Ejection Fraction (LVEF) >15% and ≤ 45%;
- New York Heart Association (NYHA) Functional Class II-IV;
- Left Ventricular End Systolic Volume (LVESVI) ≥60 cc/m² but ≤ 120 cc/ m²
- Contiguous acontractile (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) regions of the left ventricle as evidenced by a Cardiac Magnetic Resonance (CMR) or Computed Tomography (CT);
Key exclusion criteria (21 listed)
- Calcified ventricular wall in the area of intended scar exclusion as verified by echocardiography or equivalent;
- Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent;
- Cardiac Resynchronization Therapy (CRT) device placement ≤ 60 days prior to enrollment;
- Significant diastolic dysfunction, defined as a pseudo-normal Doppler filling pattern with E/A ratio > 2;
- Thin walled, paradoxically moving septal scar that would preclude successful support of the anchor pairs as evidenced by CMR;
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 | Device | Revivent TC |
Primary outcome
Primary Safety Endpoint
Time frame: 6 months
Overall rate of serious adverse events (SAEs)
Primary Efficacy Endpoint
Time frame: 6 months
Decrease in LV volume (left ventricular end-systolic volume index) compared to Baseline
6 secondary outcomes
Secondary Safety Endpoint
Time frame: 6 months
Secondary Efficacy Endpoint
Time frame: 6 months
Secondary Efficacy Endpoint
Time frame: 6 months
Secondary Efficacy Endpoint
Time frame: 6 months
Secondary Efficacy Endpoint
Time frame: 6 months
Secondary Efficacy Endpoint
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Sponsor WebsiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Revivent TC in people with Heart Failure, run by BioVentrix at 1 site in Spain.
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 9 inclusion and 21 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: finished, as of the sponsor's last update on 12 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 Spain. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Safety Endpoint (time frame: 6 months). 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?
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 12 Mar 2021.