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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).
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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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period. | Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure. | 12 months post procedure |
| Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs. | Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin ("Cardiovascular Serious Adverse Event") with the potential of leading to:
A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required. | 12 months post procedure |
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Inclusion Criteria:
All patients who are indicated for an atrial fibrillation ablation procedure.
Exclusion Criteria:
Pregnant women.
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All patients who are indicated for an atrial fibrillation ablation procedure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus Linz | Linz | Austria | ||||
| AZ Middelheim |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Subjects | Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment |
|
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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 | Oct 20, 2015 |
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| Antwerp |
| Belgium |
| Jessa Ziekenhuis | Hasselt | Belgium |
| CHR Citadelle | Liège | Belgium |
| Foothills Medical Center | Calgary | Canada |
| QE II Health Sciences | Hailfax | Canada |
| Royal Jubilee hospital | Newmarket | Canada |
| Institut de Cardiologie de Quebec (Hôpital Laval) | Québec | Canada |
| Fuwai Heart Hospital & Cardiovascular Institute | Beijing | China |
| Third Xiangya Hospital of Central South University | Changsha | China |
| West China Hospital | Chengdu | China |
| Sir Run Run Shaw Hospital | Hangzhou | China |
| Prince of Wales Hospital | Hong Kong | China |
| Ningbo 1st. Hospital | Ningbo | China |
| FN U sv. Anny v Brno | Brno | Czechia |
| Clinique Rhône-Durance-Avignon | Avignon | France |
| CHU Brest | Brest | France |
| CHU Gabriel Montpied | Clermont-Ferrand | France |
| CHRU Lille | Lille | France |
| Clinique Pasteur | Toulouse | France |
| Zentralklinikum Bad Berka | Bad Berka | Germany |
| Herz- und Gefässzentrum Bad Bevensen | Bad Bevensen | Germany |
| Kerckhoff Klinik | Bad Nauheim | Germany |
| Vivantes Klinikum Am Urban | Berlin | Germany |
| Immanuel Klinikum Bernau - Herzzentrum Brandenburg | Bernau | Germany |
| Universitätsklinikum Köln | Cologne | Germany |
| Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem | Göttingen | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | Germany |
| Herzzentrum Leipzig | Leipzig | Germany |
| Klinikum Ludwigshafen | Ludwigshafen | Germany |
| Märkische Kliniken GmbH Klinikum Lüdenscheid | Lüdenscheid | Germany |
| Kliniken Maria Hilf | Mönchengladbach | Germany |
| Fortis Hospital Limited | Bangalore | India |
| Medanta - The Medicity Hospital | Gurgaon | India |
| Escorts Heart Institute and Research Centre | New Delhi | India |
| Christian Medical College & Hospital | Vellore | India |
| Ospedale Cardinal Massaia | Asti | Piedmon | 14100 | Italy |
| Ospedale San Giovanni di Dio - Torregalli | Florence | Tuscany | 50122 | Italy |
| Ospedale SS Antonio e Biagio | Alessandria | Italy |
| Fondazione Giovanni Paolo II | Campobasso | Italy |
| Ospedale Spirito Santo | Pescara | Italy |
| Ospedale San Filippo Neri | Roma | Italy |
| Catharina Hospital | Eindhoven | Netherlands |
| Erasmus Rotterdam | Rotterdam | Netherlands |
| Haga Hospital | The Hague | Netherlands |
| Hospital Santa Cruz | Carnaxide | Portugal |
| Hospital Santa Maria | Lisbon | Portugal |
| Centro Hospitalar de Vila Nova de Gaia | Vila Nova de Gaia | Portugal |
| Prince Sultan Cardiac Center | Riyadh | Saudi Arabia |
| Yeungnam University Medical Center | Daegu | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Yonsei University Health System | Seoul | South Korea |
| Hospital general Universitario de Alicante | Alicante | Spain |
| Hospital Universitario de Bellvitge | Barcelona | Spain |
| Hospital Virgen de las Nieves | Granada | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | Spain |
| Hospital do Meixoeiro | Vigo | Spain |
| Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| Royal Sussex County Hospital | Brighton | United Kingdom |
| Castle Hill Hospital | Hull | United Kingdom |
| Leeds General Infirmary | Leeds | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
| Procedure |
|
|
| 12-month Visit |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data for 1 patient is missing. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Data is missing for 3 patients. | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Indication for procedure | Data is missing for 7 patients. | Count of Participants | Participants |
| |||||||||||||||
| Had Prior AF Ablation | Data missing for 7 patients. | Count of Participants | Participants |
| |||||||||||||||
| Percentage of Left Ventricular Ejection Fraction | Measure Analysis Population Description: Data not collected from all patients. | Mean | Standard Deviation | % |
| ||||||||||||||
| Left Atrial Diameter | Data not collected from all patients. | Mean | Standard Deviation | mm |
| ||||||||||||||
| Left Atrial Volume | Data not collected from all patients. | Mean | Standard Deviation | mL |
|
| 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 | Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period. | Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure. | Subjects that completed 12-month visit | Posted | Count of Participants | Participants | 12 months post procedure |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period. | Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure. | Treated Subjects | Posted | Count of Participants | Participants | 12 months post procedure |
|
| |||||||||||||||||||||||||||
| Primary | Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs. | Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin ("Cardiovascular Serious Adverse Event") with the potential of leading to:
A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required. | Enrolled subjects | Posted | Count of Participants | Participants | 12 months post procedure |
|
|
SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window)
Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other [Not Including Serious] Adverse Events were not monitored/assessed.
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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 | All Enrolled Subjects | Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent. | 8 | 2,035 | 356 | 2,035 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal ECG | Cardiac disorders | Systematic Assessment |
| ||
| Angina (Chest Pain) | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Atrio-esophageal fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| AV Fistula | Vascular disorders | Systematic Assessment |
| ||
| Complete Heart Block | Cardiac disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
| ||
| Exacerbation of Pre-Existing Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Heart Block | Cardiac disorders | Systematic Assessment |
| ||
| Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Obstruction/Perforation/Damage of The Vascular System | Vascular disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Palpitation | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial Effusion Without Tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial Effusion/Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Cardiac disorders | Systematic Assessment |
| ||
| Pulmonary Vein Stenosis | Vascular disorders | Systematic Assessment |
| ||
| Pulmonary Vein Thrombus | Vascular disorders | Systematic Assessment |
| ||
| Sinus Node Dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Stroke/cerebral vascular accidents | Nervous system disorders | Systematic Assessment |
| ||
| Vascular Access/Bleeding Complications | Vascular disorders | Systematic Assessment |
| ||
| Ventricular Arrhythmia Requiring Defibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Vessel Wall/Valvular Damage or Insufficiency | Vascular disorders | Systematic Assessment |
|
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SAEs were adjudicated by the sponsor.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Clinical Research Scientist | Abbott | 6517564067 | eric.grovender@abbott.com |
| Aug 14, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
|
| Persistent AF |
|
| Permanent AF |
|
| No |
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