Heart FailureCONFIGURE-HFNCT01568138
Prospective Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy
A study testing PliCath HF System in people with Heart Failure, run by BioVentrix at 4 sites in 4 countries.
Trial summary
The purpose of the study is to determine the safety, and feasibility of a device, which enables LV volume and radius reduction through scar exclusion in patients whose systolic HF is due to ischemic cardiomyopathy. Appropriate subjects will have akinetic or dyskinetic scar located in the antero-septal LV distribution. 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?
- PliCath HF System
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2010to Aug 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80
- 15% ≥ LVEF ≤ 45%
- NYHA FC II-III
- 60 cc/m² ≥ LVESV/I ≤ 120 cc/m²
- Acontractile (akinetic and/or dyskinetic) scar located in the antero-septalapical region due to prior infarction as evidenced by an echocardiogram and/or an MRI
- 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 an echocardiogram and/or an MRI
- Agree to required follow-up visits
Who cannot join
- Calcified ventricular wall in the akinetic region
- Thrombus or intra-ventricular mass in left atrium or ventricle Cardiac Resynchronization Therapy (CRT) device placement within prior 60 days of enrollment
- Significant diastolic dysfunction, defined as a pseudonormal 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 an MRI
- Cardiac valve disease which, in the opinion of the investigator, will require surgery
- Mitral Regurgitation > 1+
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- Intolerance or unwillingness to take warfarin
- Functioning pacemaker leads in antero-apical RV which, in the opinion of the investigator, would interfere with anchor placement.
- Pulmonary Arterial Pressure > 60 mm Hg
- Myocardial Infarction within prior 90 days enrollment
- Previous CVA or TIA which resulted, in the opinion of the investigator, in a significant residual neurological deficit
- 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
- Pregnant or planning to become pregnant during the study
- Enrolled in any concurrent study other than observational
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: This Study is a Multi-center, Prospective, Single-armed, Study Designed to Evaluate the Safety and Feasibility of the BioVentrix PliCath HF System for Left Ventricular (LV) Volume and Radius Reduction Through Scar Exclusion in Patients Whose Systolic HF is Due to Ischemic Cardiomyopathy.
The purpose of the study is to determine the safety, and feasibility of a device, which enables LV volume and radius reduction through scar exclusion in patients whose systolic HF is due to ischemic cardiomyopathy.
Appropriate subjects will have akinetic or dyskinetic scar located in the antero-septal LV distribution. Use of this device replicates the geometric reconfiguration of the ventricle achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating, unsupported heart, thereby creating the option of avoiding the use of cardiopulmonary bypass pump (CBP).
Read the detailed description
Congestive heart failure is the "epidemic" of cardiovascular disease (Eugene Braunwald, NEJM 1997), yet there is no cure. The American Heart Association (AHA) reports the nearly five million Americans are afflicted. Approximately 1.5 million admissions in the US are due to heart failure (HF); it is the number one cost-item for Medicare, comprising 6% of its total expenditures.
In view of the limitations of existing therapy, physicians have sought alternative treatments. In this regard, there has been longstanding interest in surgical reconstruction of the failing heart. The underlying premise has been to surgically reduce the size of the ventricular chamber by removing a portion of the ventricular wall to decrease chamber radius. A reduction of chamber radius reduces wall stress for a given pressure so that the remaining muscle is put into a more favorable mechanical state.
The BioVentrix PliCath HF System consists of implantable anchors, the delivery system, and accessories, which are sterile and biocompatible. These devices are used in the reconfiguration of the abnormal cardiac geometry that is causing dysfunction by excluding a portion of the left ventricular chamber.
The procedure is based on the premise that the beneficial effects of Left Ventricular Reconstruction (LVR) via radius and volume reduction, can be realized by excluding a portion of the scarred left ventricle wall circumference. The procedure is similar to a Dor procedure except that it utilizes a series of anchors in place of the Fontan stitch and patch to exclude infarcted tissue and reduce the size of the left ventricle chamber and the scarred left ventricle wall. Because the ventricle is not resected, it is possible to do the procedure without a cardiopulmonary bypass pump.
The validity of this concept has been documented. Geometric confirmation was initially accomplished in a bench model, where radius was decreased by 24% and volume was diminished by 35% after exclusion of an antero-septal wall segment in dilated, explanted porcine hearts.
When using the PliCath System in accomplishing LV reconfiguration, the fundamental technical maneuver is placement of a hollow needle through a predetermined site in the anterior wall scar, across the LV chamber, and through a predetermined site in the scarred interventricular septum. Once achieved, a flexible guidewire is advanced through the needle and into the free right ventricular (RV) chamber. Once the wire is completely through the septum, a dilator enables passage of a 14Fr Introducer to traverse the needle route, allowing introduction of an internal, elongated anchor which can be oriented into appropriate alignment and matched with an external anchor of identical length and alignment. The anchors, which are placed in the RV and on the epicardium as a result of the original needle passage, can be brought toward each other until contact between the two walls is established and they are apposed along their lengths. The action is repeated (i.e., repeated needle sticks and anchor placement), along the long axis of the LV until a linear portion of antero-lateral wall is in contact with a corresponding portion of the septum, excluding the entire intervening wall segment from the circumference of the chamber.
The device is designed to allow removal at any stage of deployment prior to removal of the "Leash" attached to the hinged, internal anchor.
- Conditions
- Heart Failure
- Being tested
- PliCath HF System
- Keywords
- 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.
PliCath HF SystemDevice
Also called Epicardial Catheter-based Ventricular Restoration, Left or Surgical Ventricular Reconstruction, Dor
To evaluate the safety and feasibility of the BioVentrix PliCath HF Epicardial Catheter-based Ventricular Reduction (ECVR) System for left ventricular (LV) volume reduction in heart failure (HF). The System utilizes anchors that are implanted into the scarred portion of the heart, rendering the ventricle smaller.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of overall rate of serious adverse device effects
The primary safety endpoint is an assessment of the overall rate of serious adverse device effects through 12 months as adjudicated by the Data Monitoring Committee.
Measured: 12 Months Post-operative
Secondary outcomes (1)
Assessment of overall rate of serious adverse events
The secondary safety endpoint is an assessment of the overall rate of serious adverse events through 12 months as adjudicated by the Data Monitoring Committee.
Measured: 12 Months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startAug 2010
- Primary completionAug 2015
- Study completionAug 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioVentrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University, Centro Diagnostico Italiano, Advance Research Associates
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568138
- Sponsor's protocol ID
- 20032-P
- Acronym
- CONFIGURE-HF
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2012
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study is a Multi-center, Prospective, Single-armed, Study Designed to Evaluate the Safety and Feasibility of the BioVentrix PliCath HF System for Left Ventricular (LV) Volume and Radius Reduction Through Scar Exclusion in Patients Whose Systolic HF is Due to Ischemic Cardiomyopathy.
- ClinicalTrials.gov ID
- NCT01568138
- Acronym / sponsor ID
- CONFIGURE-HF / 20032-P
- Conditions
- Heart Failure
- Keywords
- Ventricular Remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- BioVentrixIndustry (pharma, biotech, devices)
- Collaborators
- Ohio State University, Centro Diagnostico Italiano, Advance Research Associates
- Study start
- Aug 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Apr 2012 (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.
The purpose of the study is to determine the safety, and feasibility of a device, which enables LV volume and radius reduction through scar exclusion in patients whose systolic HF is due to ischemic cardiomyopathy.
Appropriate subjects will have akinetic or dyskinetic scar located in the antero-septal LV distribution. Use of this device replicates the geometric reconfiguration of the ventricle achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating, unsupported heart, thereby creating the option of avoiding the use of cardiopulmonary bypass pump (CBP).
Detailed description
Congestive heart failure is the "epidemic" of cardiovascular disease (Eugene Braunwald, NEJM 1997), yet there is no cure. The American Heart Association (AHA) reports the nearly five million Americans are afflicted. Approximately 1.5 million admissions in the US are due to heart failure (HF); it is the number one cost-item for Medicare, comprising 6% of its total expenditures.
In view of the limitations of existing therapy, physicians have sought alternative treatments. In this regard, there has been longstanding interest in surgical reconstruction of the failing heart. The underlying premise has been to surgically reduce the size of the ventricular chamber by removing a portion of the ventricular wall to decrease chamber radius. A reduction of chamber radius reduces wall stress for a given pressure so that the remaining muscle is put into a more favorable mechanical state.
The BioVentrix PliCath HF System consists of implantable anchors, the delivery system, and accessories, which are sterile and biocompatible. These devices are used in the reconfiguration of the abnormal cardiac geometry that is causing dysfunction by excluding a portion of the left ventricular chamber.
The procedure is based on the premise that the beneficial effects of Left Ventricular Reconstruction (LVR) via radius and volume reduction, can be realized by excluding a portion of the scarred left ventricle wall circumference. The procedure is similar to a Dor procedure except that it utilizes a series of anchors in place of the Fontan stitch and patch to exclude infarcted tissue and reduce the size of the left ventricle chamber and the scarred left ventricle wall. Because the ventricle is not resected, it is possible to do the procedure without a cardiopulmonary bypass pump.
The validity of this concept has been documented. Geometric confirmation was initially accomplished in a bench model, where radius was decreased by 24% and volume was diminished by 35% after exclusion of an antero-septal wall segment in dilated, explanted porcine hearts.
When using the PliCath System in accomplishing LV reconfiguration, the fundamental technical maneuver is placement of a hollow needle through a predetermined site in the anterior wall scar, across the LV chamber, and through a predetermined site in the scarred interventricular septum. Once achieved, a flexible guidewire is advanced through the needle and into the free right ventricular (RV) chamber. Once the wire is completely through the septum, a dilator enables passage of a 14Fr Introducer to traverse the needle route, allowing introduction of an internal, elongated anchor which can be oriented into appropriate alignment and matched with an external anchor of identical length and alignment. The anchors, which are placed in the RV and on the epicardium as a result of the original needle passage, can be brought toward each other until contact between the two walls is established and they are apposed along their lengths. The action is repeated (i.e., repeated needle sticks and anchor placement), along the long axis of the LV until a linear portion of antero-lateral wall is in contact with a corresponding portion of the septum, excluding the entire intervening wall segment from the circumference of the chamber.
The device is designed to allow removal at any stage of deployment prior to removal of the "Leash" attached to the hinged, internal anchor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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
- 15% ≥ LVEF ≤ 45%
- NYHA FC II-III
- 60 cc/m² ≥ LVESV/I ≤ 120 cc/m²
- Acontractile (akinetic and/or dyskinetic) scar located in the antero-septalapical region due to prior infarction as evidenced by an echocardiogram and/or an MRI
Key exclusion criteria (16 listed)
- Calcified ventricular wall in the akinetic region
- Thrombus or intra-ventricular mass in left atrium or ventricle Cardiac Resynchronization Therapy (CRT) device placement within prior 60 days of enrollment
- Significant diastolic dysfunction, defined as a pseudonormal 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 an MRI
- Cardiac valve disease which, in the opinion of the investigator, will require surgery
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 |
|---|---|---|
| PliCath HF SystemAlso: Epicardial Catheter-based Ventricular Restoration, Left or Surgical Ventricular Reconstruction, DorTo evaluate the safety and feasibility of the BioVentrix PliCath HF Epicardial Catheter-based Ventricular Reduction (ECVR) System for left ventricular (LV) volume reduction in heart failure (HF). The System utilizes anchors that are implanted into the scarred portion of the heart, rendering the ventricle smaller. | Device | – |
Primary outcome
Assessment of overall rate of serious adverse device effects
Time frame: 12 Months Post-operative
The primary safety endpoint is an assessment of the overall rate of serious adverse device effects through 12 months as adjudicated by the Data Monitoring Committee.
1 secondary outcome
Assessment of overall rate of serious adverse events
Time frame: 12 Months post-operative
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 11 Mar 2021.
- Sponsor company web siteLink 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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PliCath HF System in people with Heart Failure, run by BioVentrix at 4 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 9 inclusion and 16 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 11 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 4 sites in Latvia, Lithuania, Poland, Russia. 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?
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?
Assessment of overall rate of serious adverse device effects (time frame: 12 Months Post-operative). 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 11 Mar 2021.