Long-term results of the DelIVery for Pulmonary Arterial Hypertension trial.

ABSTRACT:

Background

The DelIVery for Pulmonary Arterial Hypertension clinical trial was a multi-center, prospective, single arm, Investigational Device Exemption study utilizing a fully implantable, programmable intravascular delivery system consisting of a pump and a catheter for intravenous treprostinil. The study met its primary endpoint and demonstrated that the intravascular delivery system significantly reduced catheter related complications at 22,000 subject-days of follow-up compared with a predefined objective performance criterion. Here we summarize the results obtained during a 6.4-year follow-up period.

Methods

Throughout study follow-up, participants had clinic visits and medication refills at least every 12 weeks (dependent on the subjects' dose). All adverse events and

SUBMITTER: Gomberg-Maitland M 

PROVIDER: S-EPMC6831973 | biostudies-literature | 2019 Oct-Dec

REPOSITORIES: biostudies-literature