EUCTR2005-000326-24-GB
Active, not recruiting
Phase 1
The Effects of Nitric Oxide for Inhalation during Left Ventricular Assist Device (LVAD) Implantation. - INOT41
INO Therapeutics0 sites110 target enrollmentJune 30, 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- INO Therapeutics
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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.
Outcomes
Primary Outcomes
Not specified
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