AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational

Stroke Clinical Trial

— ACP LA  

Official title:

AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01962051
• Other study ID #: CL07123
• Status: Withdrawn
• Start date: October 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (documentation may include an electrocardiogram (ECG), Holter, or event recorder)

• Subject must have a LAA closure procedure that has already been planned or scheduled by his/her attending physician before entry in the study

• Subject must be greater than or equal to 18 years of age

Exclusion Criteria:

• Subject with an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device

• Subject underwent LAA closure procedure prior to study entry (i.e. before signing informed consent

• Subject who has a history of surgical ASD or PFO repair

• Subject with a history of stroke and unrepaired PFO

• Subject who has moderate to severe aortic or mitral valve stenosis or regurgitation requiring surgical or percutaneous intervention as assessed by the Investigator

• Subject who has a mitral or aortic prosthetic valve

• Subject with NYHA grade 4

• Subject with evidence of moderate pericardial effusion at baseline evaluation

• Subject who has complex atheroma with mobile plaque of the descending aorta and/or aortic arch

• Subject who has an intracardiac thrombus

• Subject who has carotid disease as assessed by the Investigator, requiring treatment, which includes revascularization and/or medical treatment

• Subject with active infection or active endocarditis

• Subject who has an acute or recent myocardial infarction (MI) or unstable angina (recent is defined as within 3 months of implant date)

• Subject who has had recent major cardiac surgical procedure (recent is defined as within 6 months of implant date)

• Subject with malignancy or other illness where life expectancy is less than one year

• Subject who is pregnant, breastfeeding, or desires to become pregnant during their first six months of follow-up

• Subject or legally authorized representative who is unable to provide informed consent

• Subject who will not be able to be followed for the duration of the clinical study

• Subject with any medical disorder or severe disability that would interfere with completion or evaluation of clinical study results (for example uncontrolled hypertension, uncontrolled diabetes, blood disorder, renal failure, in situ IVC filter)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Appendage
• Stroke

Intervention

Device:
• Amplatzer Cardiac Plug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the performance of the ACP device in closure of the LAA	Defined as absence of flow or flow of =3mm jet into the LAA at procedure and at 6 months, 1 year and 2 years as assessed by Transoesophageal Echocardiography (TOE).	2 years post implant
Primary	The rate of occurrence for any reported adverse event experienced by subjects enrolled		Through 2 years