Atrial FibrillationLATINAWERICANCT03651323
Latin America Registry on WatchmanTM Outcomes in Real Life
An observational study of Atrial Fibrillation, run by Centro Medico Docente la Trinidad at 1 site in Venezuela.
Trial summary
Left atrial appendage (LAA) occlusion with WatchmanTM has emerged as viable alternative to anticoagulation therapy in randomized controlled trials. The device has FDA approved since 2015 and the firsts Latin American cases were performed in 2012. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Left atrial appendage closure with Watchman device
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteVenezuela
- Study dates
- 1 Oct 2018to 1 Dec 2018
- 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 atrial fibrillation and indication for left atrial appendage closure
Who may be able to join
- Patients who were eligible for a WatchmanTM device implantation according to current international and local guidelines and per physician and institution discretion.
Who cannot join
- Patient who were currently enrolled in another investigational study or registry that would directly interfere with the current study aims.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation: Latin America Registry on WatchmanTM Outcomes in Real Life
Left atrial appendage (LAA) occlusion with WatchmanTM has emerged as viable alternative to anticoagulation therapy in randomized controlled trials. The device has FDA approved since 2015 and the firsts Latin American cases were performed in 2012. However, there is no real world data from Latin American experience in terms of success and outcomes.
Read the detailed description
Approximately 450 subjects will be enrolled in the study. Up to 50 sites in Latin America will participate in the study.
Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the registry.
Clinical history of each patient will be analyzed for a period of 6 months after the procedure according the standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects in the registry.
- Conditions
- Atrial Fibrillation
- Being tested
- Left atrial appendage closure with Watchman device
- Keywords
- Atrial fibrillation, Left atrial appendage, Stroke
- 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.
Left atrial appendage closure with Watchman deviceDevice
Percutaneous left atrial appendage closure using Watchman device
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Periprocedural complications
Pericardial effusion, stroke, device embolization and bleeding
Measured: At implant
Incidence of Stroke
Stroke
Measured: 6 months follow up
Incidence of Death
Cardiovascular and no cardiovascular death
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Docente la Trinidad
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Luis Cressa, Centro Medico Docente la Trinidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651323
- Sponsor's protocol ID
- ISRCAR00144
- Acronym
- LATINAWERICA
- Status last verified
- Aug 2018
- First submitted
- 24 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation: Latin America Registry on WatchmanTM Outcomes in Real Life
- ClinicalTrials.gov ID
- NCT03651323
- Acronym / sponsor ID
- LATINAWERICA / ISRCAR00144
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Left atrial appendage, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centro Medico Docente la TrinidadUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 29 Aug 2018 (actual)
- 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.
Left atrial appendage (LAA) occlusion with WatchmanTM has emerged as viable alternative to anticoagulation therapy in randomized controlled trials. The device has FDA approved since 2015 and the firsts Latin American cases were performed in 2012. However, there is no real world data from Latin American experience in terms of success and outcomes.
Detailed description
Approximately 450 subjects will be enrolled in the study. Up to 50 sites in Latin America will participate in the study.
Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the registry.
Clinical history of each patient will be analyzed for a period of 6 months after the procedure according the standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects in the registry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation and indication for left atrial appendage closure
Key inclusion criteria (1 listed)
- Patients who were eligible for a WatchmanTM device implantation according to current international and local guidelines and per physician and institution discretion.
Key exclusion criteria (1 listed)
- Patient who were currently enrolled in another investigational study or registry that would directly interfere with the current study aims.
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 |
|---|---|---|
| Left atrial appendage closure with Watchman devicePercutaneous left atrial appendage closure using Watchman device | Device | – |
Primary outcome
Incidence of Periprocedural complications
Time frame: At implant
Pericardial effusion, stroke, device embolization and bleeding
Incidence of Stroke
Time frame: 6 months follow up
Stroke
Incidence of Death
Time frame: 6 months follow up
Cardiovascular and no cardiovascular death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Atrial Fibrillation (AF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Centro Medico Docente la Trinidad at 1 site in Venezuela.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Venezuela. 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?
Results are not available in the source record.
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?
Incidence of Periprocedural complications (time frame: At implant). 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 29 Aug 2018.