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Heart FailureNCT03183895

Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study

A study testing Left ventricular restoration in people with Heart Failure and Cardiomyopathies, run by Ancora Heart, Inc. at 19 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Cardiomyopathies
What is being tested?
Left ventricular restoration
Type of treatment
Medical device
How many people
132 participants
Where
19 sitesin 10 countries
Study dates
15 Jan 2019to Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Subjects who present with heart failure with or without functional mitral regurgitation due to dilated cardiomyopathy of ischemic or non-ischemic etiology
  • For subjects with FMR, severity of FMR: ≥ Moderate 2+
  • For subjects without FMR, LVEDD ≥ 55 mm
  • Ejection Fraction: ≥20 to ≤40%
  • Symptom Status: NYHA II-IVa
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  • Patients to be considered for the present study will be required to have received all appropriate guidelines-recommended therapies for at least 3 months prior to the enrollment with stable doses of drugs for at least 1 month.
  • Surgical risk:
  • For patients with FMR only: the Heart Team must assess as high-risk and may utilize risk score or comorbidities to demonstrate high risk features. High risk for mitral valve surgery is defined utilizing established risk scores (STS, Euro-Score II) in conjunction with comorbidities as recommended by MVARC (frailty index; major organ system compromise not to be improved postoperatively; procedure specific impediments) (MVARC Part 1)
  • For all patients: Subject is eligible for cardiac surgery (namely, the patient is in a condition that allows a potential conversion to open surgery in case of procedural complications). This criterion adds a safety level for the patients
  • Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
  • Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment

Who cannot join

  • Life expectancy <1 yr due to noncardiac conditions
  • NYHA functional class IVb or ACC/AHA stage D heart failure
  • Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or nonischemic etiology
  • Fixed pulmonary artery systolic pressure >70 mm Hg
  • Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction
Show all 35Show fewer
  • Mitral valve anatomy which may preclude proper device treatment
  • Mitral valve area <4.0 cm2 (if new device therapy may further decrease the mitral orifice area)
  • Any prior mitral valve surgery or transcatheter mitral valve procedure
  • Stroke or transient ischemic event within 30 days
  • Modified Rankin Scale ≥ 4 disability
  • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Severe symptomatic carotid stenosis (>70% by ultrasound).
  • Myocardial infarction ≤ 30 days
  • Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
  • Tricuspid valve disease requiring surgery or severe tricuspid regurgitation (per ASE guidelines; core lab assessment)
  • Aortic valve disease requiring surgery
  • Moderate or severe aortic valve stenosis or regurgitation
  • Aortic valve prosthesis
  • Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus, or vegetation
  • Need for any cardiovascular surgery (other than for MV disease)
  • Active endocarditis
  • Anatomical pathology/constraints preventing appropriate access/implant of the AccuCinch System (e.g., femoral arteries will not support an 20F system)
  • Known allergy to nickel, polyester, or polyethylene
  • Active infections requiring current antibiotic therapy
  • Subjects in whom transesophageal echocardiography is contraindicated
  • Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)
  • Subjects in whom anticoagulation or antiplatelet therapy is contraindicated
  • 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 procedure.
  • Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 1 month
  • Absence of CRT with class I indication criteria for biventricular pacing (left bundle branch block pattern and QRS duration ≥150 ms)
  • Subjects on high dose steroids or immunosuppressant therapy
  • Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits
  • Patient is unable or unwilling to sign written patient information sheet and informed consent form before study enrollment. This study excludes vulnerable populations as defined in protocol section 18.

Trial locations and contacts

19 sites in 10 countries.

19 sites in 10 countries

France6 sites

  • Hôpital Cardio-Vasculaire Louis Pradel

    Bron, 69500

  • Hôpital de La Timone

    Marseille, 13005

  • Paris Hôpital de la Pitié-Salpêtrière

    Paris, 75013

  • Pessac (CHU Bordeaux)

    Pessac, Avenue Magellen, 33600

  • Hôpital Civil de Strasbourg

    Strasbourg, 67000

  • Clinique Pasteur

    Toulouse

Other trials in France

Italy3 sites

  • Maria Cecilia Hospital

    Cotignola, Via Madonna Di Genova, 1,, 48033

  • IRCCS Policlinico San Donato

    Milan, Piazza Edmondo Malan, 1 San Donato Milanese,, 20037

  • Ospedale San Raffaele

    Milan, Via Olgettina, 60,, 20132

Other trials in Italy

Belgium2 sites

  • Onze Lieve Vrouwziekenhuis

    Aalst, Aaslt, 9300

  • AZ Sint-Jan Brugge

    Bruges, 10800

Other trials in Belgium

Netherlands2 sites

  • St. Antonius Ziekenhuis

    Nieuwegein

  • Erasmus Medical Center

    Rotterdam, 3015 GD

Other trials in Netherlands

Belarus1 site

  • Republican Scientific and Practical Centre of Cardiology

    Minsk, 220036

Other trials in Belarus

Czechia1 site

  • Na Homolce Hospital

    Prague, 15030

Other trials in Czechia

Lithuania1 site

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, 08661

Other trials in Lithuania

Poland1 site

  • Medical University of Warsaw

    Warsaw, 02-097

Other trials in Poland

Switzerland1 site

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

United Kingdom1 site

  • Royal Brompton & Harefield NHS Trust

    London, Sydney St, Chelsea, London, SW3 6NP

Other trials in United Kingdom

About this study

Official title: Safety and Performance Evaluation of the AccuCinch® Ventricular Restoration System for the Treatment of Heart Failure With or Without Functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy - The CorCinch-EU Study

This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy

Read the detailed description

The primary objectives of this study are to evaluate the safety and performance of the AccuCinch Ventricular Repair System for the treatment of heart failure and functional mitral regurgitation in symptomatic adult patients with or without functional mitral regurgitation (FMR) and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who remain symptomatic despite optimized medical therapy.

Subjects with FMR must present with at least moderate FMR, a reduced ejection fraction (≤40%) and high operative risk as assessed by the Heart Team. The Heart Team may utilize established risk scores (STS, Euro-Score II) in conjunction with comorbidities as recommended by MVARC (frailty index; major organ system compromise not to be improved postoperatively; procedure specific impediments).

Subjects without FMR must present a markedly dilated left ventricle with LVEDD ≥ 55 mm and reduced ejection fraction (≤40%). These patients are not potential candidates for "conventional intervention", because their mitral valve is not in need of repair or replacement. Therefore, AccuCinch represents the sole treatment option for these patients, who are not selected on the basis of high surgical risk.

Being tested
Left ventricular restoration
Medical subject headings
Heart Failure, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left ventricular restorationDevice

    The AccuCinch® Ventricular Repair System, implanted in the sub-valvular space of the left ventricle, is intended to reduce significant symptomatic mitral regurgitation and reverse left ventricular remodeling due to dilated cardiomyopathy of either ischemic or non-ischemic etiology via percutaneous interventional methods.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety outcome: 30-day major adverse events (MAEs)

    Major adverse event (MAE) where MAE is a composite of the following device- or procedure-related events:

    1. All-cause mortality
    2. Stroke
    3. Life-threatening bleeding (MVARC scale)
    4. Major vascular complications
    5. Major cardiac structural complications
    6. Myocardial infarction or coronary ischemia requiring PCI or CABG
    7. Stage 2 or 3 acute kidney injury (includes new dialysis)
    8. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for >48 h.
    9. Emergency surgery or re-intervention related to the device or access procedure

    Measured: 30-day

Secondary outcomes (6)

  1. Technical success: Successful access, delivery, and retrieval of AccuCinch System components, successful deployment of the AccuCinch implant without need for unplanned or emergency surgery or re-intervention

    Successful access, delivery, and retrieval of all AccuCinch catheters. Deployment and correct positioning of the intended AccuCinch implant, and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure measured upon completion of the procedure.

    Measured: 30-day

  2. Structural performance: Assessment of device integrity

    No migration, embolization, detachment, fracture, hemolysis, thrombosis or endocarditis; and no para-device complications (erosion, effusion requiring surgery or drainage or producing tamponade, damage to the MV apparatus)

    Measured: 30-day

  3. Clinical outcome: Freedom from re-hospitalizations or re-interventions for the underlying condition

    Freedom from re-hospitalizations or re-interventions for the underlying condition

    Measured: 30-day

  4. Clinical outcome: Improvement in NYHA functional class

    Improvement in NYHA functional class when compared to baseline assessment

    Measured: 30-day

  5. Clinical outcome: Improvement in six-minute walk test

    Improvement in six-minute walk test (6MWT) when compared to baseline assessment

    Measured: 30-day

  6. Clinical outcome: Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL)

    Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) when compared to baseline

    Measured: 30-day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2017
  2. Study start15 Jan 2019
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03183895
Sponsor's protocol ID
4631
Status last verified
Jan 2025
First submitted
7 Jun 2017
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Left ventricular restoration in people with Heart Failure and Cardiomyopathies, run by Ancora Heart, Inc. at 19 sites in 10 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 12 inclusion and 35 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 29 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 19 sites in France, Italy, Belgium, Netherlands, Belarus and 5 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?

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 outcome: 30-day 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?

On the ClinicalTrials.gov record for NCT03183895.

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 29 Jan 2025.

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