Status:
COMPLETED
A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
Lead Sponsor:
Lantheus Medical Imaging
Conditions:
Pulmonary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.
Detailed Description
This Phase IV safety study will provide safety data on potential systemic and pulmonary hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo right heart cardiac...
Eligibility Criteria
Inclusion
- Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons
- Be male or female above the age of 18
- Female patients who no longer have child-bearing potential
- Women of Child-Bearing Potential(WOCBP) who:
- are not pregnant and have been using an adequate and medically approved method of contraception
- have a negative urine pregnancy test
- Be able and willing to communicate effectively with study center personnel.
Exclusion
- Women who are pregnant or lactating
- Known hypersensitivity or contraindication to or greater heart block
- Previous heart transplant
- Known right-to-left shunt (including atrial septal defect)
- Severe pulmonary artery hypertension (i.e., \> 75 mmHg
- Current uncontrolled ventricular tachycardia
- Second-degree or greater heart block
- Any contraindications for the use of a right heart catheter
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00918866
Start Date
July 1 2009
End Date
December 1 2009
Last Update
November 24 2020
Active Locations (8)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
3
Methodist Hospital
Saint Louis Park, Minnesota, United States, 55426
4
Cardiovascular Consultants
Kansas City, Missouri, United States, 64111