Heart FailureCONFIGURE-HFNCT01568164
Safety and Efficacy Study of the BioVentrix PliCath HF System
A study testing PliCath HF System in people with Heart Failure, run by BioVentrix at 19 sites in 11 countries.
Trial summary
The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 19 sitesin 11 countries
- Study dates
- Mar 2012to Dec 2019
- 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;
- Left Ventricular Ejection Fraction (LVEF) >15% and ≤ 45%;
- NYHA FC 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 CMR or 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 RV, 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 CVA or 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;
- Pregnant or planning to become pregnant during the study;
- Enrolled in any concurrent study other than observational.
Trial locations and contacts
19 sites in 11 countries.
19 sites in 11 countries
Italy6 sites
Spedali Civili di Cardiochirurgia
Brescia, 1 25123
IRCCS Istituto Policlinico San Donato
Milan, 20097
Ospedale San Raffaele
Milan, 20132
Padova University Hospital
Padova, I-35128
Azienda Ospedaliera S.Camillo-Forlanini
Rome, 87
Ospedale Le Molinetto
Torino, 10126
France2 sites
Bordeaux University Hospital Cardiology
Bordeaux, 33604
Hospital Pitie Sal Petirere Institute of Cardiology
Paris, 75013
Poland2 sites
Polish American Hospital
Katowice, 40-534
Jagiellonian University
Krakow, 31-202
United Kingdom2 sites
Kings College Hospital
London, SE594S
The Royal Brompton Hospital
London, SW36NP
About this study
Official title: Phase II Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy
The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.
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 reports the nearly five million Americans are afflicted. Approximately 1.5 million admissions in the US are due to heart failure; it is the number one cost-item for Medicare, comprising 6% of its total expenditures.
BioVentrix has developed the PliCath heart failure system, which is used to place permanent cardiac implants into the heart for the purpose of excluding scar, reconfiguring abnormal cardiac geometry that is causing dysfunction, by excluding an abnormal portion of the ventricular wall. Conceptually, the final configuration in SVR can be achieved by placing these implants.
The procedure called PliCath Epicardial Catheter-based Ventricular Restoration System (ECVR) is designed for left ventricular volume reduction in patients with heart failure in a magnitude similar to that of the predicate surgical procedure, but much less invasively. The PliCath HF System utilizes anchors that are implanted into the scarred portion of the heart, which when deployed, exclude some of the scar similar to what is excluded by cinching the purse string suture with the patch, rendering the ventricle smaller, and is employed in a surgical setting, with and without the use of cardiopulmonary bypass.
The PliCath HF System has anchors (implants) that are deployed using fluoroscopic imaging.
- Conditions
- Heart Failure
- Being tested
- PliCath HF System
- Keywords
- Epicardial Catheter-based Restoration, Surgical/Left Ventricular Reconstruction, Ventricular Remodeling, Dor
- 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, Dor, Surgical/Left Ventricular Reconstruction
This study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix PliCath HF System for left ventricular volume restoration in patients with ischemic cardiomyopathy.
| Study group | Role | What they receive |
|---|---|---|
| Device Treatment | Experimental | Treatment with the investigational device. Receives: Device: PliCath HF System |
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.
An assessment of the overall rate of serious adverse events (SAEs) at 1 year and 2 years as adjudicated by the Data Monitoring Committee (DMC).
Measured: 24 Months
Primary Efficacy Endpoint - Reduction in LV Volume
An assessment of measurable decrease in LV volume by either an echo or a CMR at 6 months, 1 year and 2 years.
Measured: 24 Months
Secondary outcomes (5)
Secondary Safety Endpoint: Assessment of overall rate of serious adverse device effects.
The secondary safety endpoint will be an assessment of the overall rate of serious adverse device effects (SADEs) through 2 years as adjudicated by the DMC.
Measured: 24 Months post operatively
Secondary Efficacy Endpoint: • Change in Left Ventricular Ejection Fraction
Change in Left Ventricular Ejection Fraction (LVEF)as measured by ECHO or MRI.
Measured: 24 Months
Secondary Efficacy Endpoint: Hospital readmission for HF
Hospital readmission for HF including surgical intervention such as Ventricular Assist Device, Cardiac Resynchronization Therapy, Intra-Aortic Balloon Pump, or transplant;
Measured: 24 Months
Secondary Efficacy Endpoint: Clinical utility
Change in NYHA Class, Change in a standardized 6-minute corridor walk test; Change in Quality of Life (QOL) by Minnesota Living with Heart Failure (MLHF) Questionnaire.
Measured: 24 Months
Secondary Efficacy Endpoint: NT-proBNP
Change in NT-proBNP levels
Measured: 24 Months
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 startMar 2012
- Primary completionDec 2019
- Study completionDec 2019
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 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioVentrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University, CDI Centro Diagnostico Italiano S.p.A, Advance Research Associates
- Responsible party
- Sponsor
- Investigators
- Lon Annest, MD, Study director, Chief Medical Officer, BioVentrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568164
- Sponsor's protocol ID
- CIP-0015
- 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
Publications
Wechsler AS, Sadowski J, Kapelak B, Bartus K, Kalinauskas G, Rucinskas K, Samalavicius R, Annest L. Durability of epicardial ventricular restoration without ventriculotomy. Eur J Cardiothorac Surg. 2013 Sep;44(3):e189-92; discussion e192. doi: 10.1093/ejcts/ezt292. Epub 2013 Jun 5.
PubMed 23739293
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
- Phase II Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01568164
- Acronym / sponsor ID
- CONFIGURE-HF / CIP-0015
- Conditions
- Heart Failure
- Keywords
- Epicardial Catheter-based Restoration, Surgical/Left Ventricular Reconstruction, Ventricular Remodeling, Dor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- BioVentrixIndustry (pharma, biotech, devices)
- Collaborators
- Ohio State University, CDI Centro Diagnostico Italiano S.p.A, Advance Research Associates
- Study start
- Mar 2012
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (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 this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.
Detailed description
Congestive heart failure is the "epidemic" of cardiovascular disease (Eugene Braunwald, NEJM 1997), yet there is no cure. The American Heart Association reports the nearly five million Americans are afflicted. Approximately 1.5 million admissions in the US are due to heart failure; it is the number one cost-item for Medicare, comprising 6% of its total expenditures.
BioVentrix has developed the PliCath heart failure system, which is used to place permanent cardiac implants into the heart for the purpose of excluding scar, reconfiguring abnormal cardiac geometry that is causing dysfunction, by excluding an abnormal portion of the ventricular wall. Conceptually, the final configuration in SVR can be achieved by placing these implants.
The procedure called PliCath Epicardial Catheter-based Ventricular Restoration System (ECVR) is designed for left ventricular volume reduction in patients with heart failure in a magnitude similar to that of the predicate surgical procedure, but much less invasively. The PliCath HF System utilizes anchors that are implanted into the scarred portion of the heart, which when deployed, exclude some of the scar similar to what is excluded by cinching the purse string suture with the patch, rendering the ventricle smaller, and is employed in a surgical setting, with and without the use of cardiopulmonary bypass.
The PliCath HF System has anchors (implants) that are deployed using fluoroscopic imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Treatment | Experimental | Device: PliCath HF SystemTreatment with the investigational device. |
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%;
- NYHA FC 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 CMR or CT;
Key exclusion criteria (18 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 |
|---|---|---|
| PliCath HF SystemAlso: Epicardial Catheter-based Ventricular Restoration, Dor, Surgical/Left Ventricular ReconstructionThis study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix PliCath HF System for left ventricular volume restoration in patients with ischemic cardiomyopathy. | Device | Device Treatment |
Primary outcome
Primary Safety Endpoint - Overall rate of serious adverse events.
Time frame: 24 Months
An assessment of the overall rate of serious adverse events (SAEs) at 1 year and 2 years as adjudicated by the Data Monitoring Committee (DMC).
Primary Efficacy Endpoint - Reduction in LV Volume
Time frame: 24 Months
An assessment of measurable decrease in LV volume by either an echo or a CMR at 6 months, 1 year and 2 years.
5 secondary outcomes
Secondary Safety Endpoint: Assessment of overall rate of serious adverse device effects.
Time frame: 24 Months post operatively
Secondary Efficacy Endpoint: • Change in Left Ventricular Ejection Fraction
Time frame: 24 Months
Secondary Efficacy Endpoint: Hospital readmission for HF
Time frame: 24 Months
Secondary Efficacy Endpoint: Clinical utility
Time frame: 24 Months
Secondary Efficacy Endpoint: NT-proBNP
Time frame: 24 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 11 Mar 2021.
- Results publication: PubMed 23739293Wechsler AS, Sadowski J, Kapelak B, Bartus K, Kalinauskas G, Rucinskas K, Samalavicius R, Annest L. Durability of epicardial ventricular restoration without ventriculotomy. Eur J Cardiothorac Surg. 2013 Sep;44(3):e189-92; discussion e192. doi: 10.1093/ejcts/ezt292. Epub 2013 Jun 5.
- 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.
Lon Annest, MD study director
Chief Medical Officer, BioVentrix
19 sites in 11 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 19 sites in 11 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 18 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 19 sites in Italy, France, Poland, United Kingdom, Austria and 6 more countries. 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?
Primary Safety Endpoint - Overall rate of serious adverse events. (time frame: 24 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?
On the ClinicalTrials.gov record for NCT01568164, 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 11 Mar 2021.