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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation; Left Atrial Appendage
• Intervention / Treatment: Device: Amplatzer Cardiac Plug

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Hospital Na Homolce Cardiocentrum
• Germany
  • Bonn, Germany
    • University of Bonn
  • Bonn, Germany
    • St. Marien-Hospital Bonn
  • Frankfurt, Germany
    • Cardiovascular center Frankfurt
  • Frankfurt, Germany
    • Kardiocentrum Frankfurt an der Klinik Rotes Kreuz
  • Goettingen, Germany
    • University Medicine Goettingen
  • Hamburg, Germany
    • Asklepios Kliniken GmbH/Asklepios Klinik Harburg
  • Pirmasens, Germany
    • Stadt Krankenhaus Pirmasens gGmbh
• Ireland
  • Dublin, Ireland
    • Mater Misericordiae University Hospital
• Spain
  • Badajoz, Spain
    • Hospital Universitario Infanta Cristina
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Murcia, Spain
    • Hospital Universitario 'Virgen de la Arrixaca"
  • Pamplona, Spain
    • Hospital de Navarra
• United Kingdom
  • Brighton, United Kingdom
    • Royal Sussex County Hospital-UK
  • Oxford, United Kingdom
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-valvular atrial fibrillation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Delivery system entry	Device: Amplatzer Cardiac Plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of occurrence for any reported adverse event experienced by subjects enrolled.		Through 2 years
Closure	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).	6 months
Technical success	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	At implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimated): February 8, 2013

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CL03562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Manuscript has been submitted to Euro Intervention Sept 2016