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ABLATOR Brazil - Ablation Observational Study (Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041233
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

Condition or disease Intervention/treatment
Atrial Fibrillation Other: Observation / Data Collection

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 833 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: ABLATOR Brazil - Ablation Observational Study (Registry)
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : April 27, 2020
Estimated Study Completion Date : April 27, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Observation / Data Collection

    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.



Primary Outcome Measures :
  1. Unsuccessful treatment rate, measured by the number of repeated procedure [ Time Frame: within 12 months after ablation procedure ]
    measured by the number of repeated procedure


Secondary Outcome Measures :
  1. Cardiovascular Serious Adverse Event [ Time Frame: within 12 months after ablation procedure ]
    Reporting of SAE through the CRF

  2. Death [ Time Frame: within 12 months after ablation procedure ]
    Reporting of death through the CRF



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who are indicated for an atrial fibrillation ablation procedure, except for pregnant women.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041233


Locations
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Brazil
Santa Casa de Misericórdia da Bahia
Salvador, Bahia, Brazil, 40050-410
Cardioritmo Eletrofisiologia e Marpasso
Fortaleza, CE, Brazil
HOME - Hospital Ortopédico e Medicina Especializada LTDA.
Brasília, DF, Brazil, 70200730
Hospital Santa Rita
Vitória, ES, Brazil
Vitoria Apart Hotel
Vitória, ES, Brazil
Procardiaco
Rio de Janeiro, RJ, Brazil
Unimed de Volta Redonda
Volta Redonda, RJ, Brazil
Hospital São Vicente de Paulo
Passo Fundo, RS, Brazil
SOS Cardio
Florianopolis, SC, Brazil
Insitituto de Moléstias Cardiovasculares - IMC
São José do Rio Prêto, SP, Brazil
BP
São Paulo, SP, Brazil
SEMAP
São Paulo, SP, Brazil
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: André Luiz D'Avila SOS Cardio
Additional Information:

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03041233    
Other Study ID Numbers: SJM-CIP-10192
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes