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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).
The objectives of this registry are the following:
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation / Data Collection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Unsuccessful Treatment Rate | Percent of subjects with a repeat procedure | up to 6 and 12 months after ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Serious Adverse Event (SAE) | Percent of subjects with Cardiovascular SAE. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who are indicated for an atrial fibrillation ablation procedure, except for pregnant women.
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| Name | Affiliation | Role |
|---|---|---|
| André Luiz D'Avila | SOS Cardio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardioritmo Eletrofisiologia e Marpasso | Fortaleza | Ceará | Brazil | |||
| Hospital Santa Rita |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled | Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled | Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unsuccessful Treatment Rate | Percent of subjects with a repeat procedure | 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. | Posted | Count of Participants | Participants | up to 6 and 12 months after ablation procedure |
|
|
Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled | Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientist | Abbott | 7639541350 | emily.jesser@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2017 | May 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
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| up to 12 months after ablation procedure |
| Vitória |
| EspÃrito Santo |
| Brazil |
| Vitoria Apart Hotel | Vitória | EspÃrito Santo | Brazil |
| Santa Casa de Misericórdia da Bahia | Salvador | Estado de Bahia | 40050-410 | Brazil |
| HOME - Hospital Ortopédico e Medicina Especializada LTDA. | BrasÃlia | Federal District | 70200730 | Brazil |
| Procardiaco | Rio de Janeiro | Rio de Janeiro | Brazil |
| Unimed de Volta Redonda | Volta Redonda | Rio de Janeiro | Brazil |
| Hospital São Vicente de Paulo | Passo Fundo | Rio Grande do Sul | Brazil |
| SOS Cardio | Florianópolis | Santa Catarina | Brazil |
| Insitituto de Moléstias Cardiovasculares - IMC | São José Do Rio Prêto | São Paulo | Brazil |
| BP | São Paulo | São Paulo | Brazil |
| SEMAP | São Paulo | São Paulo | Brazil |
| Inclusion/Exclusion Criteria Not Met |
|
| Sponsor Request |
|
| Duplicate subject |
|
| Re-ablation |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Cardiovascular Serious Adverse Event (SAE) | Percent of subjects with Cardiovascular SAE. | The analysis population is subjects who received AF ablation for which 6-month and 12-month follow-up data was available for, respectively. | Posted | Count of Participants | Participants | up to 6 and 12 months after ablation procedure |
|
|
|
| Secondary | Death in Subjects Who Underwent an Ablation Procedure | Percent of subjects experiencing death within 12 months of ablation procedure | Posted | Count of Participants | Participants | up to 12 months after ablation procedure |
|
|
|
| 5 |
| 833 |
| 30 |
| 833 |
| 1 |
| 833 |
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | Non-systematic Assessment |
|
| Drowning | General disorders | Non-systematic Assessment |
|
| Catheter Deformation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pseudoaneurysm | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Death | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hematuria | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pulmonary congestion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Chest Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Skin lesion | Infections and infestations | Non-systematic Assessment |
|
| Pericardial Effusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Bruise | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Car accident | General disorders | Non-systematic Assessment |
|
| Tamponade | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Perioperative infarction | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Sinus dysfunction/asystole after interruption of flutter | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Muscle abscess | Infections and infestations | Non-systematic Assessment |
|
| Hemorrhagic stroke | Nervous system disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Prolonged Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
|
| Prolonged hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Change in medical strategy | Cardiac disorders | Non-systematic Assessment |
|
| Suspected bacterial endocarditis | Cardiac disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
|