The Effects of Nitric Oxide for Inhalation during Left Ventricular Assist Device (LVAD)Implantation. - INOT41

• Conditions: acute right ventricular failure; MedDRA version: 9.1Level: LLTClassification code 10063082Term: Acute right ventricular failure

• Registration Number: EUCTR2005-000326-24-DE
• Lead Sponsor: INO Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-06
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

-scheduled to undergo their first LVAD implantation, (or at least 6 months after explantation of a previous LVAD).
- has a pulmonary vascular resistance of at least 2.5 Wood units (200 dynes/second) in the 30 days prior to LVAD placement.
- greater than 18 years of age.
- signed IRB approved informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patients with congestive heart failure due to giant cell myocarditis or restrictive
cardiomyopathy
- Elective Biventricular Assist Device (BiVAD) surgery, or current support with a
temporary BiVAD)
- LVAD procedure expected to be done without cardiopulmonary bypass.
- pregnancy (a negative pregnancy test must be documented prior to enrollment).
- received nitric oxide by inhalation therapy within the past 24 hours.
- investigational drugs that are expected to change systemic or pulmonary vascular
resistance are not allowed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified