Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation.

An Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device Used to Reduce Mitral Regurgitation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28876

Enrollment

Registered

2008-05-20

Start date

2006-06-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure Mitral Regurgitation Mitral valve disease Mitral valve insufficiency Hartfalen Mitralisklepinsufficiëntie Mitralisklep Kleplijden

Interventions

Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Symptomatic heart failure 2. Functional MR 2+ - 4+ 3. LVEF < 45%

Exclusion criteria

Exclusion criteria: 1. MR of organic origins 2. Significant co-morbidities

Design outcomes

Primary

Measure	Time frame
Percent of patients who remain free from device-related major adverse events: - death - myocardial infarction - tamponade - emergent cardiac surgery at 6 months.	—

Secondary

Measure	Time frame
- Percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction in mitral anterior posterior dimension at 6 months. - Improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: * decrease in NYHA class, or increase in Minnesota Living with Heart Failure score, or increase in exercise capacity at 30 days and 6 months.	—

Measure

Time frame

- Percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction in mitral anterior posterior dimension at 6 months. - Improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: * decrease in NYHA class, or increase in Minnesota Living with Heart Failure score, or increase in exercise capacity at 30 days and 6 months.

—

Contacts

Public ContactL. Pierard

Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman Bâtiment B 35 · B-4000 Liège 1

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)