Stroke Clinical Trial
— ACP LAOfficial title:
AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational
NCT number | NCT01962051 |
Other study ID # | CL07123 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | January 2014 |
Verified date | January 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
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 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 Exclusion Criteria: - 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 - 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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 2 years post implant | |
Primary | The rate of occurrence for any reported adverse event experienced by subjects enrolled | Through 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |