AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational (ACP LA)

January 31, 2019 updated by: Abbott Medical Devices
The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with nonvalvular atrial fibrillation (NVAF)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Delivery system Entry
Device: Amplatzer Cardiac Plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 years post implant
The rate of occurrence for any reported adverse event experienced by subjects enrolled
Time Frame: Through 2 years
Through 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL07123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data collected as study stopped before sites activated

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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