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

Stroke Clinical Trial

— ACPR  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786486
• Other study ID #: CL03562
• Status: Completed
• Start date: August 2009
• Est. completion date: January 2014

Study information

• Verified date: June 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• 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 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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Appendage
• Stroke

Intervention

Device:
• Amplatzer Cardiac Plug

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Czechia,  Germany,  Ireland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of occurrence for any reported adverse event experienced by subjects enrolled.		Through 2 years
Primary	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
Primary	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