AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol

The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in subjects with nonvalvular atrial fibrillation and assess adverse events up to two (2) or more years post implant.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Left Atrial Appendage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Na Homolce Cardiocentrum, Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 be ≥18 years of age

Exclusion criteria

Subject with an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device
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 as assessed by the investigator
Subject who has a mitral or aortic prosthetic valve
Subject who has a planned ablation procedure for atrial fibrillation 30 days after the ACP implant
Subject with New York Heart Association (NYHA) grade 4
Subject with evidence of 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 6 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 e.g. uncontrolled hypertension, uncontrolled diabetes, renal failure, in situ inferior vena cava (IVC) filter)

Treatment and study plan

AMPLATZER Cardiac Plug

Device

Primary outcomes

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

Time frame: Through 2 years
Closure

Time frame: 6 months

Defined as absence of flow or flow of ≤3mm jet into the LAA at procedure and at six (6) months as assessed by Transoesophageal Echocardiography (TOE).
Technical success

Time frame: At implant

Defined as delivery and release of the ACP device, including recapture and/or replacement, as necessary. This success will be calculated among subjects in whom the device enters the body

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: ACPR

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2014
First posted: Feb 8, 2013
Registry last updated: Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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