Atrial FibrillationACP LANCT01962051
AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational
An observational study of Atrial Fibrillation and Left Atrial Appendage, run by Abbott Medical Devices.
Trial summary
The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study. 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jan 2014
- 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: Subjects with nonvalvular atrial fibrillation (NVAF)
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 have a LAA closure procedure that has already been planned or scheduled by his/her attending physician before entry in the study
- Subject must be greater than or equal to 18 years of age
Who cannot join
- Subject with an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device
- Subject underwent LAA closure procedure prior to study entry (i.e. before signing informed consent
- 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 requiring surgical or percutaneous intervention as assessed by the Investigator
- Subject who has a mitral or aortic prosthetic valve
Show all 19Show fewer
- Subject with NYHA grade 4
- Subject with evidence of moderate 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 3 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 example uncontrolled hypertension, uncontrolled diabetes, blood disorder, renal failure, in situ IVC filter)
About this study
The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.
- 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.
Evaluate the performance of the ACP device in closure of the LAA
Defined as absence of flow or flow of ≤3mm jet into the LAA at procedure and at 6 months, 1 year and 2 years as assessed by Transoesophageal Echocardiography (TOE).
Measured: 2 years post implant
The rate of occurrence for any reported adverse event experienced by subjects enrolled
Measured: Through 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: St. Jude Medical business decision
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962051
- Sponsor's protocol ID
- CL07123
- Acronym
- ACP LA
- Status last verified
- Jan 2019
- First submitted
- 10 Oct 2013
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No data collected as study stopped before sites activated
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational
- ClinicalTrials.gov ID
- NCT01962051
- Acronym / sponsor ID
- ACP LA / CL07123
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Stroke
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: St. Jude Medical business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Oct 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 ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- 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
- Subjects with nonvalvular atrial fibrillation (NVAF)
Key inclusion criteria (3 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 have a LAA closure procedure that has already been planned or scheduled by his/her attending physician before entry in the study
- Subject must be greater than or equal to 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 underwent LAA closure procedure prior to study entry (i.e. before signing informed consent
- 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 requiring surgical or percutaneous intervention as assessed by the Investigator
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
Evaluate the performance of the ACP device in closure of the LAA
Time frame: 2 years post implant
Defined as absence of flow or flow of ≤3mm jet into the LAA at procedure and at 6 months, 1 year and 2 years as assessed by Transoesophageal Echocardiography (TOE).
The rate of occurrence for any reported adverse event experienced by subjects enrolled
Time frame: Through 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: No. No data collected as study stopped before sites activated
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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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.
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.
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 3 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: withdrawn, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the performance of the ACP device in closure of the LAA (time frame: 2 years post implant). The study lists 2 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 4 Feb 2019.