Safety and Efficacy clinical trial of the PTMA System to reduce mitral valve regurgitation in heart failure.

A multi-center, open-label, single-arm study of the Safety and Efficacy of the Percutaneous TransvenOus Mitral AnnuloplastY System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20121

Enrollment

Registered

2008-10-30

Start date

2008-10-30

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 valve, Mitral valve insufficiency, Mitral regurgitation, Valve disease

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Moderate functional MR 2. Symptomatic heart failure 3. LV dysfunction (25% /= 50 years

Exclusion criteria

Exclusion criteria: 1. MR of organic origins 2. Severe mitral leaflet tethering 3. Not capable of walking 100 meters in 6 minutes 4. Existing bi-ventricular pacemaker with leads in the coronary sinus or its tributaries 5. Significant co-morbidities

Design outcomes

Primary

Measure	Time frame
- Safety: freedom from MACE rate - Efficacy: Quantitative MR reduction at 6 months and device success.	—

Secondary

Measure	Time frame
- Safety - Efficacy	—

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)