Recruiting

Phase 1

iCoapsysVIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study

Sponsor:

Myocor

Code:

NCT00512005

Conditions

Mitral Valve Regurgitation

Left Ventricular Dysfunction

Heart Failure

Mitral Insufficiency

Mitral Incompetence

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Percutaneous mitral valve repair

Study Details

Brief summary:

The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement.

Conditions

Mitral Valve Regurgitation

Left Ventricular Dysfunction

Heart Failure

Mitral Insufficiency

Mitral Incompetence

Study ID

NCT00512005

Start date

Jan, 2008

Status verified date

May, 2008

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.
NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF greater than or equal to 30%

Key Exclusion Criteria:

History of pericarditis.
Creatinine > 2.2 at the time of the procedure
INR > 1.8 at the time of the procedure
Prior pericardial intervention (including CABG, pericardiotomy or pericardiocentesis).
Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).
Any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure
Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis).
Structural abnormality of the mitral valve
Valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention.
Pericardial effusion >5 mm via echocardiography.
Posterior wall end-diastolic dimension >1.3 cm.
Left ventricular end diastolic diameter > 7.0 cm.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Percutaneous mitral valve repair

Ventricular reshaping to treat functional mitral insufficiency

Primary outcome measure

Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System [ Time Frame: Intra-procedure and peri-procedure ]

Central Contacts and Locations

Central contacts

Cyril J. Schweich, MD

763 494 5400 schweich@myocor.com

Adam K Hoyhtya, MS

763 494 5430 hoyhtya@myocor.com

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Pamela Hyde, RN

404-712-7665 Pamela.hyde@emoryhealthcare.org

Principal Investigator:

Peter Block, MD

Evanston Northwestern Healthcare - Evanston Hospital

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Claudia Focks

847-570-2366 cfocks@enh.org

Principal Investigator:

Theodore Feldman, MD

Shawnee Mission Hospital

Recruiting

Shawnee Mission, Kansas, United States, 66204

Contacts

Millie Salkind

913-671-6516 msalkind@kcheart.com

Principal Investigator:

Paul Kramer, MD

Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55440

Contacts

Sara Olson, RN

612-863-7601 sara.olson@allina.com

Principal Investigator:

Wesley Pedersen, MD

More Information

Sponsor

Myocor

Last update posted

Jun 24, 2009

Last verified

May, 2008

Keywords

Functional Mitral Regurgitation (FMR)
Ischemic Mitral Regurgitation
Less invasive repair
Percutaneous MV repair
Mitral Valve Repair
Heart Failure
Left Ventricular Dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Myocor on 2009-06-24.