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

NCT01786486 | Completed DMC

• 1 other identifier: CL03562
• Study Type: observational
• Target: 204
• Locations: 5 countries
• Sites: 15

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.

Conditions

Atrial Fibrillation; Left Atrial Appendage; Stroke

Outcome Measures

Primary Outcomes (3)

• 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

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

Patients with non-valvular atrial fibrillation

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 be ≥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 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (15)

Hospital Na Homolce Cardiocentrum

Prague, Czechia

Location

St. Marien-Hospital Bonn

Bonn, Germany

Location

University of Bonn

Bonn, Germany

Location

Cardiovascular Center Frankfurt

Frankfurt, Germany

Location

Kardiocentrum Frankfurt an der Klinik Rotes Kreuz

Frankfurt, Germany

Location

University Medicine Goettingen

Göttingen, Germany

Location

Asklepios Kliniken GmbH/Asklepios Klinik Harburg

Hamburg, Germany

Location

Stadt Krankenhaus Pirmasens gGmbh

Pirmasens, Germany

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

Hospital Universitario Infanta Cristina

Badajoz, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario 'Virgen de la Arrixaca"

Murcia, Spain

Location

Hospital de Navarra

Pamplona, Spain

Location

Royal Sussex County Hospital-UK

Brighton, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

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
• Target Duration: 4 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: February 8, 2013
• Study Start: August 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (2); DE (7); IE (1); CZ (1); ES (4)