Clinical Trial: Rheos® Diastolic Heart Failure Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Rheos® Diastolic Heart Failure Trial
Brief Summary: The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be followed up to one year post implant.
Detailed Summary:
Sponsor: CVRx, Inc.
Current Primary Outcome:
- Assess left ventricular mass index (LVMI). [ Time Frame: at six months post- randomization. ]
- Assess safety by evaluating all adverse events. [ Time Frame: through six months post -implant ]
Original Primary Outcome:
- Assess left ventricular mass index (LVMI). [ Time Frame: at six months post- randomizatiom. ]
- Assess safety by evaluating all adverse events. [ Time Frame: through six months post -implant ]
Current Secondary Outcome: To assess difference between randomization groups in blood pressure changes, blood levels and quality of life. [ Time Frame: six months post-implant ]
Original Secondary Outcome: Same as current
Information By: CVRx, Inc.
Dates:
Date Received: July 17, 2008
Date Started: July 2008
Date Completion:
Last Updated: October 19, 2016
Last Verified: October 2016
