NCT00572091

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1 heart-failure

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 6, 2008

Status Verified

November 1, 2008

Enrollment Period

1.2 years

First QC Date

December 10, 2007

Last Update Submit

November 5, 2008

Conditions

Heart FailureMitral Regurgitation

Keywords

Heart FailureMitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • percent of patients who remain free from device-related major adverse events: death, myocardial infarction, tamponade, emergent cardiac surgery

    30 days

Secondary Outcomes (2)

  • percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction in mitral anterior posterior dimension

    30 days

  • improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in 6 minute walk, improvement in VO2 max.

    30 days

Study Arms (1)

1

EXPERIMENTAL

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

Device: PTMA Implant

Interventions

PTMA ImplantDEVICE

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

1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic heart failure
  • functional MR 2+ - 4+
  • LVEF 20% - 50%

You may not qualify if:

  • MR of organic origins
  • significant co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen

Aachen, D-52057, Germany

Location

MeSH Terms

Conditions

Heart FailureMitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart Valve Diseases

Study Officials

  • Rainer Hoffmann, MD

    Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 12, 2007

Study Start

February 1, 2007

Primary Completion

April 1, 2008

Study Completion

November 1, 2008

Last Updated

November 6, 2008

Record last verified: 2008-11

Locations

DE(1)