ABLATOR Brazil - Ablation Observational Study (Registry)

An observational study of Atrial Fibrillation, run by Abbott Medical Devices at 12 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this registry is to assess the performance and clinical effectiveness of a combination of St. Jude Medical (SJM)/Abbott mapping and ablation products in the treatment of subjects with atrial fibrillation (AF). 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?: Observation / Data Collection
How many people: 833 participants
Where: 12 sitesBrazil
Study dates: 13 Apr 2017to 27 Apr 2020
How long will I take part?: 12 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: All patients who are indicated for an atrial fibrillation ablation procedure, except for pregnant women.

Who may be able to join

All patients who are indicated for an atrial fibrillation ablation procedure.

Who cannot join

Pregnant women

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Brazil12 sites

HOME - Hospital Ortopédico e Medicina Especializada LTDA.
Brasília, Federal District, 70200730
SOS Cardio
Florianópolis, Santa Catarina
Cardioritmo Eletrofisiologia e Marpasso
Fortaleza, Ceará
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul
Procardiaco
Rio de Janeiro, Rio de Janeiro
Santa Casa de Misericórdia da Bahia
Salvador, Estado de Bahia, 40050-410
Insitituto de Moléstias Cardiovasculares - IMC
São José Do Rio Prêto, São Paulo
BP
São Paulo, São Paulo
SEMAP
São Paulo, São Paulo
Hospital Santa Rita
Vitória, Espírito Santo
Vitoria Apart Hotel
Vitória, Espírito Santo
Unimed de Volta Redonda
Volta Redonda, Rio de Janeiro

Other trials in Brazil

About this study

Read the detailed description

The objectives of this registry are the following:

To confirm patient safety as part of the post market surveillance study.
To assess performance of a combination of SJM products during procedures.
To assess the learning curve with a combination of SJM products.
To collect operator feedback on a combination of SJM products.

All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry.

In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.

Conditions: Atrial Fibrillation
Being tested: Observation / Data Collection
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Observation / Data CollectionOther
The following data will be reviewed / collected:
Baseline Visit: Patient demographics; Atrial fibrillation History; Cardiovascular history; Cardiac medical history.
Ablation Procedure: Devices used; Ablation parameters; Ablation success definition and result; Operator feedback (Device combination chosen, device maneuverability, ease of use in combination with other device); Number, experience and type of attending personnel; Definition of standard of care (follow-up procedures and occurrence).
6- and 12-month follow-up (+/- 30 DAYS): Recurrence of atrial arrhythmias: list of atrial arrhythmias since last visit, classify episodes, duration of the episodes; Changes in therapy; In case of Repeat Ablation Procedures, reconnections and new ablations will be recorded.

What is being measured

The primary outcome is the main question the study is designed to answer.

Unsuccessful Treatment Rate
Percent of subjects with a repeat procedure
Measured: up to 6 and 12 months after ablation procedure

Secondary outcomes (2)

Cardiovascular Serious Adverse Event (SAE)
Percent of subjects with Cardiovascular SAE.
Measured: up to 6 and 12 months after ablation procedure
Death in Subjects Who Underwent an Ablation Procedure
Percent of subjects experiencing death within 12 months of ablation procedure
Measured: up to 12 months after ablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 201727 Apr 2020

First posted2 Feb 2017 (estimated)
Study start13 Apr 2017
Primary completion27 Apr 2020
Study completion27 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 833 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT03041233
Sponsor's protocol ID: SJM-CIP-10192
Status last verified: Jul 2024
First submitted: 24 Jan 2017
Last updated: 17 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
Recruiting
Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Not yet recruiting
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
RecruitingObservational study
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation
Atrial Fibrillation

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ABLATOR Brazil - Ablation Observational Study (Registry)
ClinicalTrials.gov ID: NCT03041233
Acronym / sponsor ID: SJM-CIP-10192
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 833 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 13 Apr 2017 (actual)
Primary completion: 27 Apr 2020 (actual)
Study completion: 27 Apr 2020 (actual)
First posted: 2 Feb 2017 (estimated)
Results: Posted 17 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The objectives of this registry are the following:

To confirm patient safety as part of the post market surveillance study.
To assess performance of a combination of SJM products during procedures.
To assess the learning curve with a combination of SJM products.
To collect operator feedback on a combination of SJM products.

All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry.

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 12 Months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients who are indicated for an atrial fibrillation ablation procedure, except for pregnant women.

Key inclusion criteria (1 listed)

All patients who are indicated for an atrial fibrillation ablation procedure.

Key exclusion criteria (1 listed)

Pregnant women

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
Observation / Data CollectionThe following data will be reviewed / collected: Baseline Visit: Patient demographics; Atrial fibrillation History; Cardiovascular history; Cardiac medical history. Ablation Procedure: Devices used; Ablation parameters; Ablation success definition and result; Operator feedback (Device combination chosen, device maneuverability, ease of use in combination with other device); Number, experience and type of attending personnel; Definition of standard of care (follow-up procedures and occurrence). 6- and 12-month follow-up (+/- 30 DAYS): Recurrence of atrial arrhythmias: list of atrial arrhythmias since last visit, classify episodes, duration of the episodes; Changes in therapy; In case of Repeat Ablation Procedures, reconnections and new ablations will be recorded.	Other	–

Primary outcome

Unsuccessful Treatment Rate
Time frame: up to 6 and 12 months after ablation procedure
Percent of subjects with a repeat procedure

2 secondary outcomes

Cardiovascular Serious Adverse Event (SAE)
Time frame: up to 6 and 12 months after ablation procedure
Death in Subjects Who Underwent an Ablation Procedure
Time frame: up to 12 months after ablation procedure

Results and safety

Results posted to the registry on 17 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enrolled	833	801

Primary outcome: Unsuccessful Treatment Rate

Time frame: up to 6 and 12 months after ablation procedure. Count of participants. Unit: Participants

Measure	Enrolled n = 803
6 months	22
12 months	21

Population analysed: The analysis population is subjects who received atrial fibrillation (AF) ablation for which 6-month and 12-month follow-up data was available for, respectively.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enrolled	30 of 833 (3.6%)	1 of 833 (0.1%)	5 of 833

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Atrial Fibrillation

Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
Recruiting
Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Not yet recruiting
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
RecruitingObservational study
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation
Atrial Fibrillation

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.

André Luiz D'Avila principal investigator

SOS Cardio

12 sites 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 Abbott Medical Devices at 12 sites in Brazil.

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: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Brazil. 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?

Yes. Results are posted in the registry (first posted 17 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Unsuccessful Treatment Rate (time frame: up to 6 and 12 months after ablation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03041233.

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 17 Jul 2024.