Atrial FibrillationACPRNCT01786486
AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol
An observational study of Atrial Fibrillation and Left Atrial Appendage, run by Abbott Medical Devices at 15 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage, Stroke
- What is being tested?
- Amplatzer Cardiac Plug
- Type of treatment
- Medical device
- How many people
- 204 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Aug 2009to Jan 2014
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-valvular atrial fibrillation
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Germany7 sites
St. Marien-Hospital Bonn
Bonn
University of Bonn
Bonn
Cardiovascular Center Frankfurt
Frankfurt
Kardiocentrum Frankfurt an der Klinik Rotes Kreuz
Frankfurt
University Medicine Goettingen
Göttingen
Asklepios Kliniken GmbH/Asklepios Klinik Harburg
Hamburg
Stadt Krankenhaus Pirmasens gGmbh
Pirmasens
Spain4 sites
Hospital Universitario Infanta Cristina
Badajoz
Hospital Clinico San Carlos
Madrid
Hospital Universitario 'Virgen de la Arrixaca"
Murcia
Hospital de Navarra
Pamplona
United Kingdom2 sites
Royal Sussex County Hospital-UK
Brighton
John Radcliffe Hospital
Oxford
About this study
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
- Being tested
- Amplatzer Cardiac Plug
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplatzer Cardiac PlugDevice
| Study group | Role | What they receive |
|---|---|---|
| Delivery system entry | Not described Receives: Device: Amplatzer Cardiac Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of occurrence for any reported adverse event experienced by subjects enrolled.
Measured: 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).
Measured: 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
Measured: At implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startAug 2009
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786486
- Sponsor's protocol ID
- CL03562
- Acronym
- ACPR
- Status last verified
- Jun 2023
- First submitted
- 29 Jan 2013
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Manuscript has been submitted to Euro Intervention Sept 2016
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol
- ClinicalTrials.gov ID
- NCT01786486
- Acronym / sponsor ID
- ACPR / CL03562
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delivery system entry | – | Device: Amplatzer Cardiac Plug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-valvular atrial fibrillation
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amplatzer Cardiac Plug | Device | Delivery system entry |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: Yes. Manuscript has been submitted to Euro Intervention Sept 2016
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Left Atrial Appendage, run by Abbott Medical Devices at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Spain, United Kingdom, Czechia, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of occurrence for any reported adverse event experienced by subjects enrolled. (time frame: Through 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.