The Effects of Nitric Oxide for Inhalation during Left Ventricular Assist Device (LVAD) Implantation. - INOT41
- Conditions
- Acute right ventricular failure.MedDRA version: 7.0 Level: LLT Classification code 10054933 Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2005-000326-24-GB
- Lead Sponsor
- INO Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
The expected study population will include patients undergoing left vetricular assist device (LVAD) implantation.
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
- 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method