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

NCT02153892 | Completed DMC

• 1 other identifier: 3870
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Severe Functional Mitral Regurgitation and Heart Failure

Keywords

Functional Mitral Regurgitation; Heart Failure; Ventricular Reshaping

Outcome Measures

Primary Outcomes (3)

• 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)

  72 hours post-procedure

• 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

  24 hours post-procedure

• 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

  7 day post procedure

Secondary Outcomes (4)

• Clinical Measure

  30 day post-procedure

• Echocardiographic Measures - Composite

  30 days post-procedure

• Clinical Measure

  30 day post-procedure

• Clinical Measure

  30 day post-procedure

Other Outcomes (1)

• Additional Measures - Composite

  Collected at baseline, peri- and post-procedure, discharge or 7-days (whichever comes first) 30-day, 3, 6, and 12 months and at 2 and 3 years post procedure

Study Arms (1)

Multi-center, prospective, single-arm study

OTHER

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

Device: GDS Accucinch System

Interventions

GDS Accucinch System DEVICE

Percutaneous Coronary Intervention

Multi-center, prospective, single-arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ancora Heart, Inc.: lead

Study Sites (1)

Monash Health

Melbourne, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael Zapien

  Ancora Heart, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 3, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

AU (1)