AzTrials
AzTrials

Severe Functional Mitral Regurgitation and Heart FailureLVRECOVERNCT02153892

Feasibility of the AccuCinch® System for Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function

A study testing GDS Accucinch System in people with Severe Functional Mitral Regurgitation and Heart Failure, run by Ancora Heart, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GDS Accucinch System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteAustralia
Study dates
Aug 2014to Jan 2018
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years
  • Subjects with severe symptomatic functional mitral regurgitation of ≥ 3+ secondary to left ventricular (LV) remodeling and/or annular remodeling, as measured in accordance with the current ASE guidelines and suitable for treatment in accordance with the current AHA/ACC guidelines:
  • Left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 40%
  • Stable cardiac medical regimen for heart failure for at least 1 month
  • Stable NYHA Classification (Class III and above) for at least 1 month
  • The subject has been informed of the nature of the study, agrees to its provisions, including the possibility of conversion to surgery, and has provided written informed consent.

Who cannot join

  • Candidates will be excluded from the study if any of the following conditions are present:
  • Myocardial infarction within 90 days of the intended treatment with the device
  • Prior surgical, transcatheter, or percutaneous mitral valve intervention or mitral valve prosthesis
  • Subject has untreated coronary artery disease, which in the opinion of the treating physician and/or heart team, is clinically significant and requires revascularization
  • Non-ambulatory NYHA Class IV symptoms of heart failure or subjects in cardiogenic shock or with hemodynamic instability requiring IV inotropic support or mechanical support devices
  • Subject has the need for emergent surgery for any reason
Show all 32Show fewer
  • Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained
  • Echocardiography evidence of primary mitral valve disease causing MR or MS;
  • Moderate to severe pulmonary hypertension (PA systolic pressure ≥ 80 mm Hg) as assessed by echocardiography
  • Evidence of mitral valve stenosis with an estimated valve area less than 3.5 cm2
  • Mitral valve pathology that would prevent adequate function of the GDS Accucinch System
  • Subject is on dialysis or estimated GFR < 30mL/min/1.73m2 (Cockcroft-Gault Formula)d d Israni AK, et al. Laboratory Assessment of Kidney Disease, in Brenner and Rector's The Kidney, 9th ed. chapter 25
  • Greater than mild mitral annular calcification observed by fluoroscopy
  • Presence of aortic valve prosthesis
  • Moderate to severe aortic valve stenosis or calcification observed by echocardiography or fluoroscopy
  • Severe aortic arch calcification or mobile aortic atheroma observed by echocardiography or fluoroscopy
  • Active bacterial endocarditis or active sepsis
  • History of bleeding diathesis or coagulopathy
  • History of stroke within the prior 6 months
  • Subjects in whom anticoagulation is contraindicated
  • Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
  • Concurrent medical condition with a life expectancy of less than 12 months
  • Currently participating in another investigational drug or device study that has not reached its primary endpoint
  • Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, immunological abnormalities, and hematological abnormalities)
  • Subject with indication for concomitant surgery such as coronary artery bypass graft (CABG), aortic valve reconstruction or replacement, left ventricular remodeling surgery and congenital repair
  • Any cardiac resynchronization therapy within the last 9 months prior to treatment
  • Subject on high dose steroids or immunosuppressant therapy
  • Current problems with substance abuse (e.g. alcohol, illegal drugs, etc.)
  • Female subjects who are pregnant, lactating, or planning pregnancy within next the 36 months. Note: Childbearing age should be instructed to use safe contraception during their participation in this study.
  • Subjects who are unable or unwilling to comply with the follow-up schedule and requirements
  • Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to study required medications, to nickel, or to polyurethanes
  • Femoral artery lumen diameter of < 5.5 mm, or severe ilio-femoral tortuosity or calcification that would prevent safe placement of the 16Fr introducer sheath

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Monash Health

    Melbourne, Victoria, 3168

Other trials in Australia

About this study

Official title: Clinical Protocol - A Feasibility Study Using the AccuCinch® System in the Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function

To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.

Being tested
GDS Accucinch System
Keywords
Functional Mitral Regurgitation, Heart Failure, Ventricular Reshaping
Medical subject headings
Heart Failure

What participants receive

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

  • GDS Accucinch SystemDevice

    Percutaneous Coronary Intervention

Study groups in NCT02153892
Study groupRoleWhat they receive
Multi-center, prospective, single-arm studyOtherTo assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.
Receives: Device: GDS Accucinch System

What is being measured

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

  1. Procedural Success

    Successful use and implantation of an Accucinch System without Major Adverse Events (MAE) defined as the occurrence of any of the following: All-cause mortality, Device and/or procedure-related death; Peri-procedural myocardial infarction (MI) < or equal to 72 hrs after index procedure; Major stroke; Urgent or emergent conversion to surgery or repeat procedure (surgical or interventional therapy) for mitral valve or heart failure related deterioration; Left ventricular perforation; Major vascular complications; Major bleeding (including cardiac tamponade)

    Measured: 72 hours post-procedure

  2. Device Success

    Successful vascular access, delivery, and retrieval of the delivery system; Ability to establish access to the sub-annular groove, to deploy the Anchors, and the Anchor Links, to apply tension to the Cinch Cable, to reshape the mitral annulus, to deploy the Lock, and to cut the Cinch Cable; Intended performance of the Accucinch System measured by TTE acutely post-cinch with a reduction of MR by at least one grade

    Measured: 24 hours post-procedure

  3. Clinical Safety Measures

    Defined as freedom from MAE at discharge or 7 days post-procedure, whichever comes first; Safety measures will be reviewed and adjudicated by an independent clinical events committee (CEC); Echocardiographic measures will be assessed by an independent echocardiography core laboratory

    Measured: 7 day post procedure

Secondary outcomes (4)

  1. Clinical Measure

    NYHA Class improvement of at lease one score from baseline

    Measured: 30 day post-procedure

  2. Echocardiographic Measures - Composite

    Mitral Valve Measures: One grade reduction in MR (e.g. 3+ to 2+), or; Reduction in PISA EROA at least 25% from baseline, or; Reduction in Regurgitant Volume at least 25% Left Ventricular Measures: Reduction in Left Ventricular size (Left Ventricular End Diastolic Dimension - LVEDD) at least 5% from baseline, or: Reduction in Left Ventricular volume (Left Ventricular End Diastolic Volume -LVEDV) at least 5%, or Increase in ejection fraction (LVEF) at least 10% from baseline Left Atrial Measures: Left atrial volume index (biplane area-length method). The above echocardiographic measures will be assessed by an independent core laboratory

    Measured: 30 days post-procedure

  3. Clinical Measure

    6-minute walk test compared to baseline

    Measured: 30 day post-procedure

  4. Clinical Measure

    Quality of Life (KCCQ Questionnaire) compared to baseline

    Measured: 30 day post-procedure

Timeline

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

  1. First posted3 Jun 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionOct 2015
  4. Study completionJan 2018

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02153892
Sponsor's protocol ID
3870
Acronym
LVRECOVER
Status last verified
May 2018
First submitted
28 May 2014
Last updated
17 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing GDS Accucinch System in people with Severe Functional Mitral Regurgitation and Heart Failure, run by Ancora Heart, Inc. at 1 site in Australia.

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 6 inclusion and 32 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 17 May 2018. 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 Australia. 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?

Procedural Success (time frame: 72 hours post-procedure). The study lists 3 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 NCT02153892.

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 17 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in