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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02153892




Registration number
NCT02153892
Ethics application status
Date submitted
28/05/2014
Date registered
3/06/2014
Date last updated
17/05/2018

Titles & IDs
Public title
Feasibility of the AccuCinch® System for Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function
Scientific 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
Secondary ID [1] 0 0
3870
Universal Trial Number (UTN)
Trial acronym
LVRECOVER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Functional Mitral Regurgitation and Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - GDS Accucinch System

Other: Multi-center, prospective, single-arm study - To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.


Treatment: Devices: GDS Accucinch System
Percutaneous Coronary Intervention
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Procedural Success
Timepoint [1] 0 0
72 hours post-procedure
Primary outcome [2] 0 0
Device Success
Timepoint [2] 0 0
24 hours post-procedure
Primary outcome [3] 0 0
Clinical Safety Measures
Timepoint [3] 0 0
7 day post procedure
Secondary outcome [1] 0 0
Clinical Measure
Timepoint [1] 0 0
30 day post-procedure
Secondary outcome [2] 0 0
Echocardiographic Measures - Composite
Timepoint [2] 0 0
30 days post-procedure
Secondary outcome [3] 0 0
Clinical Measure
Timepoint [3] 0 0
30 day post-procedure
Secondary outcome [4] 0 0
Clinical Measure
Timepoint [4] 0 0
30 day post-procedure

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2018
Sample size
Target
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ancora Heart, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.
Trial website
https://clinicaltrials.gov/study/NCT02153892
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Zapien
Address 0 0
Ancora Heart, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02153892