Phase 4
Completed N=1,060
A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
Source: ClinicalTrials.gov NCT00625365 ↗Enrolled (actual)
1,060
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcomePrimary: The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration — 0 Participants
Summary
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration |
— | — |
| SECONDARY Serious Adverse Events |
— | — |
| SECONDARY Adverse Events |
114 | — |
Eligibility Criteria
Inclusion criteria
- Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to suboptimal, unenhanced images.
Exclusion criteria
- Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent.
- Prior SAE associated with perflutren, DEFINITY®, or administration of other echo contrast agent.
Data sourced from ClinicalTrials.gov (NCT00625365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.