AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational

NCT01962051 | Withdrawn DMC

• 1 other identifier: CL07123
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atrial Fibrillation; Left Atrial Appendage; Stroke

Outcome Measures

Primary Outcomes (2)

• 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

• The rate of occurrence for any reported adverse event experienced by subjects enrolled

  Through 2 years

Study Arms (1)

Delivery system Entry

Device: Amplatzer Cardiac Plug

Interventions

Amplatzer Cardiac Plug DEVICE

Delivery system Entry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with nonvalvular atrial fibrillation (NVAF)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 14, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share