Heart FailureCorCinch-HFrEFNCT03533517
Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction
A study testing AccuCinch® Ventricular Restoration in people with Heart Failure and Cardiomyopathy, Dilated, run by Ancora Heart, Inc. at 18 sites in United States.
Trial summary
This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiomyopathy, Dilated
- What is being tested?
- AccuCinch® Ventricular Restoration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 18 sitesUnited States
- Study dates
- 23 Aug 2018to 28 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study patient is at least 18-years old
- Ejection Fraction: ≥20 and ≤40%
- LV end-diastolic diameter ≥55 mm
- Symptom Status: NYHA III-IV (i.e., ambulatory)
- Treatment and compliance with optimal guideline directed medical and device-based therapies for heart failure (unless contraindicated or intolerant) for at least 3 months and stable doses for 1 month with stable defined as no more than 100% increase or 50% decrease of total daily doses.
- Patients with left bundle branch block pattern and QRS duration >150ms are required to have a CRT device for at least 3 months
- Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment
- Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
Who cannot join
- Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
- Mitral regurgitation grade 3 (moderate-severe) or more
- Prior surgical, transcatheter, or percutaneous mitral valve intervention
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization
- Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
- Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures)
Show all 24Show fewer
- NYHA class IV (i.e., non-ambulatory)
- Significant RV dysfunction (TAPSE < 14)
- Severe tricuspid regurgitation
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
- Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 20F system)
- Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)
- Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis
- Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
- Active bacterial endocarditis
- History of any stroke within the prior 3 months or Modified Rankin Scale ≥ 4 disability from any prior stroke
- Subjects in whom anticoagulation or antiplatelet therapy is contraindicated
- Known allergy to nitinol, polyester, or polyethylene
- Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure.
- Life expectancy < 1 year due to non-cardiac conditions
- Currently participating in another interventional investigational study
- Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month
- Subjects on high dose steroids or immunosuppressant therapy
- Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
University of Virginia School of Medicine
Charlottesville, Virginia, 22908
The Christ Hospital
Cincinnati, Ohio, 45219
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17101
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Baylor College of Medicine St. Luke's Medical Center
Houston, Texas, 77020
Nebraska Heart Institute / Nebraska Heart Hospital
Lincoln, Nebraska, 68526
University of Louisville
Louisville, Kentucky, 40202
Minneapolis Heart Foundation Institute
Minneapolis, Minnesota, 55407
Mt. Sinai
New York, New York, 10029
Columbia University Medical Center/NYPH
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Carilion Roanoke Memorial
Roanoke, Virginia, 24014
Intermountain Medical Center
Salt Lake City, Utah, 84109
University of California, San Francisco
San Francisco, California, 94143
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: An Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study
This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).
Read the detailed description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020.
- Conditions
- Heart Failure, Cardiomyopathy, Dilated
- Being tested
- AccuCinch® Ventricular Restoration
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuCinch® Ventricular RestorationDevice
AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)
| Study group | Role | What they receive |
|---|---|---|
| AccuCinch® Ventricular Restoration System | Experimental | Not described Receives: Device: AccuCinch® Ventricular Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by device-related or procedure-related major adverse events (MAEs)
Device-related or procedure-related major adverse events (MAEs)
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start23 Aug 2018
- Primary completion26 Mar 2021
- Study completion28 Feb 2026 (estimated)
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ancora Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Zapien, MS, CCRA, Study director, Ancora Heart, Inc.Ulrich Jorde, MD, Principal investigator, Montefiore Medical CenterAzeem Latib, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533517
- Sponsor's protocol ID
- 5017
- Acronym
- CorCinch-HFrEF
- Status last verified
- Jan 2025
- First submitted
- 11 May 2018
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study
- ClinicalTrials.gov ID
- NCT03533517
- Acronym / sponsor ID
- CorCinch-HFrEF / 5017
- Conditions
- Heart Failure, Cardiomyopathy, Dilated
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ancora Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 23 May 2018 (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.
This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).
Detailed description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AccuCinch® Ventricular Restoration System | Experimental | Device: AccuCinch® Ventricular Restoration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Study patient is at least 18-years old
- Ejection Fraction: ≥20 and ≤40%
- LV end-diastolic diameter ≥55 mm
- Symptom Status: NYHA III-IV (i.e., ambulatory)
- Treatment and compliance with optimal guideline directed medical and device-based therapies for heart failure (unless contraindicated or intolerant) for at least 3 months and stable doses for 1 month with stable defined as no more than 100% increase or 50% decrease of total daily doses.
Key exclusion criteria (24 listed)
- Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
- Mitral regurgitation grade 3 (moderate-severe) or more
- Prior surgical, transcatheter, or percutaneous mitral valve intervention
- Untreated clinically significant coronary artery disease (CAD) requiring revascularization
- Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
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 |
|---|---|---|
| AccuCinch® Ventricular RestorationAccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF) | Device | AccuCinch® Ventricular Restoration System |
Primary outcome
Safety measured by device-related or procedure-related major adverse events (MAEs)
Time frame: 30-day
Device-related or procedure-related major adverse events (MAEs)
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 30 Jan 2025.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Michael Zapien, MS, CCRA study director
Ancora Heart, Inc.
Ulrich Jorde, MD principal investigator
Montefiore Medical Center
Azeem Latib, MD principal investigator
Montefiore Medical Center
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AccuCinch® Ventricular Restoration in people with Heart Failure and Cardiomyopathy, Dilated, run by Ancora Heart, Inc. at 18 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 8 inclusion and 24 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 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
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?
Safety measured by device-related or procedure-related major adverse events (MAEs) (time frame: 30-day). 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 30 Jan 2025.