Safety and Performance of the AccuCinch® System

NCT02624960 | Withdrawn

• 1 other identifier: 4432
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, multi-center, open-label controlled study that will assess the safety and performance of the Accucinch System to induce left ventricular reverse remodeling and reduce the severity of functional mitral regurgitation in symptomatic adult patients with mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who are of high operative risk.

Conditions

Heart Failure; Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

• The additive reduction in the mitral annular axial dimensions (anteroposterior plus commissure-to-commissure axes) measured via echocardiography, paired by subject

  The differences between baseline and 6 months in the sum of the two annulus measures will be calculated for each subject and the mean change tested via the paired t-test.

  6 months

Secondary Outcomes (3)

• Device Success: Percentage of patients in whom all pre-specified device performance endpoints are met but no pre-specified device complications are met.

  30 Days, 6 months, 12 months, and 2 years

• Procedural Safety: Incidence rate of the occurrence of the individual pre-specified safety events that occur within 30 days of the index procedure

  30 days after the index procedure

• Long Term Safety: Incidence rate of the occurrence of the individual pre-specified safety events at 6 months, 1 year, and 2 years.

  6 months, 1 year, 2 years post index procedure

Study Arms (1)

Accucinch Implant

EXPERIMENTAL

Accucinch Implant procedure is completed

Device: Accucinch Implant

Interventions

Accucinch Implant DEVICE

Percutaneous implantation of the Accucinch Implant in the mitral subannular space

Accucinch Implant

Eligibility Criteria

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

You may qualify if:

• Study patient is an adult of legal consent age
• Severity of FMR: ≥ Moderate
• Ejection Fraction: ≥20 to ≤60%
• Symptom Status: NYHA II-IVa
• Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month
• Surgical risk: Subject is eligible for cardiac surgery

You may not qualify if:

• Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets)
• Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
• Prior surgical, transcatheter, or percutaneous mitral valve intervention
• Untreated clinically significant coronary artery disease requiring revascularization
• Hemodynamic instability: Hypotension or requirement for inotropic support or mechanical hemodynamic support
• Any planned cardiac surgery or interventions within the next 6 months
• NYHA class IVb (i.e., non-ambulatory) or ACC/AHA Stage D heart failure
• Fixed pulmonary artery systolic pressure \>70 mmHg
• Severe tricuspid regurgitation
• Modified Rankin Scale ≥ 4 disability
• 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
• Mitral valve area less than 4.0 cm2
• Anatomical pathology/constraints preventing appropriate access/implant of the GDS Accucinch System
• Renal insufficiency
• Mitral annular calcification

Sponsors & Collaborators

• Ancora Heart, Inc.: lead

MeSH Terms

Conditions

Heart Failure; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Study Officials

• Joachim Schofer, MD, PhD

  Medical Director, Medical Care Center Hamburg; Dept Chief, Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg Germany

  PRINCIPAL INVESTIGATOR

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: December 1, 2015
• First Posted: December 9, 2015
• Study Start: September 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2019
• Last Updated: July 27, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share