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

Completed

• Conditions: Atrial Fibrillation; Stroke; Left Atrial Appendage
• Interventions: Device: Amplatzer Cardiac Plug

• Registration Number: NCT01786486
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-08
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Delivery system entry	Amplatzer Cardiac Plug	-

Primary Outcome Measures

Name	Time	Method
Technical success	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
The rate of occurrence for any reported adverse event experienced by subjects enrolled.	Through 2 years
Closure	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).

Trial Locations

Locations (15)

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

St. Marien-Hospital Bonn; 🇩🇪 Bonn, Germany

University Medicine Goettingen; 🇩🇪 Goettingen, Germany

University of Bonn; 🇩🇪 Bonn, Germany

Hospital Na Homolce Cardiocentrum; 🇨🇿 Prague, Czechia

Asklepios Kliniken GmbH/Asklepios Klinik Harburg; 🇩🇪 Hamburg, Germany

Cardiovascular Center Frankfurt; 🇩🇪 Frankfurt, Germany

Stadt Krankenhaus Pirmasens gGmbh; 🇩🇪 Pirmasens, Germany

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland

Kardiocentrum Frankfurt an der Klinik Rotes Kreuz; 🇩🇪 Frankfurt, Germany

Hospital Universitario Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Spain

Royal Sussex County Hospital-UK; 🇬🇧 Brighton, United Kingdom

Hospital Universitario 'Virgen de la Arrixaca"; 🇪🇸 Murcia, Spain