Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients

A Multi-center Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00787293

Acronym

PTOLEMY-2

Enrollment

Registered

2008-11-07

Start date

2008-10-31

Completion date

2015-11-30

Last updated

2011-02-14

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

Conditions

Heart Failure, Mitral Regurgitation

Keywords

Heart Failure, Mitral Regurgitation, Percutaneous, Coronary sinus

Brief summary

Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.

Interventions

DEVICEPTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant

Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Functional MR 2+ - 4+ * Symptomatic heart failure, NYHA Class II to IV * LVEF \> 25% or \< 50% OR dilated mitral annulus \> 30mm

Exclusion criteria

* MR of organic origin * Severe mitral leaflet tethering * History of MI or PCI within 60 days of study procedure * Inability to walk a minimum of 100 meters in 6 minutes * Significant left main stenosis or proximal circumflex stent * Indication of non-patent CSO or discontinuous CS-GCV-AIV * Bi-ventricular with leads in CS or other devices impeding device placement * Severe aortic valvular disease * Chronic corticosteroid use other than \< 20mg prednisone for arthritis * Significant co-morbidities

Design outcomes

Primary

Measure	Time frame
Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months	30 days to 6 months

Secondary

Measure	Time frame
% of patients experiencing procedure or device-related adverse events	30 days to 6 months
Technical procedural success: % of patients maintaining a reduction of mitral annulus A/P dimension, sustained MR reduction, and decrease in left ventricular dimensions to specified degrees	6 months
Clinical status: % of treated patients exhibiting improvements in defined QoL parameters	6 months

Countries

Belgium, Czechia, Germany, Netherlands, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026