Ongoing Support for Pump Refills in the DelIVery for Pulmonary Arterial Hypertension Study

Overview

About this study

The purpose of this study is to provide ongoing support for pump refills, and replacement systems when needed, to the remaining 30 subjects in the DelIVery for PAH Study. This study will also provide monitoring and periodic reporting of safety of the Pulmonary Arterial Hypertension Implantable Vasodilator Therapy (“PIVoT”) investigational system.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient is currently enrolled in the DelIVery for PAH Study (G100017).
  • The physician and patient determine that continued use of the PIVoT system is medically advisable.
  • Patient is willing to sign and date the Patient Informed Consent Form.

Exclusion Criteria:

  • < 18 years of age. 
  • Contraindications to device implantation, including replacement or system modification can be found in the PIVoT Technical Manual.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/30/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Frantz, M.D.

Closed for enrollment

Contact information:

Pulmonary Hypertension Research Team

(507) 538-7297

More information

Publications

Publications are currently not available