A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lantheus Medical Imaging

Criteria

Inclusion Criteria:

• 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:

1. are not pregnant and have been using an adequate and medically approved method of contraception

2. have a negative urine pregnancy test

• Be able and willing to communicate effectively with study center personnel.

Exclusion Criteria:

• 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