Defects Clinical Trial - Emergency/Compassionate Use

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Approved for marketing

Expanded access to the AMPLATZER Muscular VSD Occluder

Recruitment information / eligibility
Status	Approved for marketing
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender	All
Age group	N/A and older
Eligibility	Inclusion Criteria: - Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER Muscular VSD clinical trial

Device:
• AMPLATZER Muscular VSD Occluder
AMPLATZER Muscular VSD Occluder

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Abbott Medical Devices

See also
	Status	Clinical Trial	Phase
	No longer available	`NCT00583505` - Emergency/Compassionate Use - Membranous VSD Occluder