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| Name | Class |
|---|---|
| I-Med-Pro GmbH | OTHER |
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This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial fibrillation. Conventional AF ablation is defined as pulmonary vein isolation (PVI) and any additional ablation for AF according to the standard routine of the center.
Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.
Prospective and retrospective enrollment possible
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Success | Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure | day of procedure |
| Number of Participants With 12-Month Effectiveness | Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period. | 12 months after initial AF ablation |
| Number of Participants With Acute Safety Success | Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation | 7 days after initial AF ablation |
| Number of Participants With 12-Month Safety Success | 12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure | 12-months after index procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 6-month Safety Success | 6-Month safety success was defined as freedom from Serious Adverse Events 6-months after index procedure | 6-months after index procedure |
Inclusion Criteria:
Exclusion Criteria:
As this is a registry only data of patients will be included who have been treated according to the current AF guidelines and the daily routine of the center.
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Each participating site will enroll 10 consecutive conventional AF patients who are treated according to the standard routine of the center. Patients eligible should be in accordance with the AF Guidelines.
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Hindricks, Prof. Dr. | Herzzentrum Leipzig - Universitätsklinik | Principal Investigator |
| Kristin Ruffner, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Städtisches Klinikum Karlsruhe GmbH | Karlsruhe | Baden-Würtemberg | 76133 | Germany | ||
| Herz- und Gefäßklinik |
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| ID | Title | Description |
|---|---|---|
| FG000 | Registry Population | All participants enrolled in the C-FIRM registry. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrolled population
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| ID | Title | Description |
|---|---|---|
| BG000 | Registry Population | All participants enrolled in the C-FIRM registry. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Participants With Acute Success | Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure | All treated patients | Posted | Count of Participants | Participants | day of procedure |
|
|
12-months
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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 Population | All patients enrolled in the registry | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amaurosis fugax / volatile blindness right eye | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Director | Abbott | 6517566717 | kristin.ruffner@abbott.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2014 | Sep 17, 2019 | Prot_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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| Bad Neustadt an der Saale |
| Bavaria |
| 97616 |
| Germany |
| Klinikum Coburg GmbH | Coburg | Bavaria | 96450 | Germany |
| Kardiologische Gemeinschaftspraxis am Park Sanssouci | Potsdam | Brandenburg | 14471 | Germany |
| Herz- und Diabeteszentrum NRW | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR | Dresden | Saxony | 01099 | Germany |
| Herzzentrum Leipzig | Leipzig | Saxony | 04289 | Germany |
| Unfallkrankenhaus Berlin | Berlin | 12683 | Germany |
| Erasmus Medical Center | Rotterdam | 3015 | Netherlands |
| years |
|
| 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 |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| New York Heart Association Class | The New York Heart Association Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. Class I = no limitation of physical activity. Class II = slight limitation Class III = marked limitation Class IV = unable to carry on any physical activity without discomfort | Count of Participants | Participants |
|
| Type of Atrial Fibrillation | Count of Participants | Participants |
|
| Left Ventricle Ejection Fraction | Mean | Standard Deviation | percent |
|
| Left Atrium Diamter | Mean | Standard Deviation | millimeter |
|
|
| Primary | Number of Participants With 12-Month Effectiveness | Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period. | Treated patients with 12-month follow-up data | Posted | Count of Participants | Participants | 12 months after initial AF ablation |
|
|
|
| Primary | Number of Participants With Acute Safety Success | Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation | Analysis population for whom data are available | Posted | Count of Participants | Participants | 7 days after initial AF ablation |
|
|
|
| Primary | Number of Participants With 12-Month Safety Success | 12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure | Treated patients for whom 12-month safety data is available | Posted | Count of Participants | Participants | 12-months after index procedure |
|
|
|
| Other Pre-specified | Number of Participants With 6-month Safety Success | 6-Month safety success was defined as freedom from Serious Adverse Events 6-months after index procedure | Treated patients for whom 6-month safety data is available | Posted | Count of Participants | Participants | 6-months after index procedure |
|
|
|
| 73 |
| 3 |
| 73 |
| 0 |
| 73 |
| Strong hematoma left groin/knee | Vascular disorders | Non-systematic Assessment |
|
| Ventricular extrasystole ablatiion | Cardiac disorders | Non-systematic Assessment |
|
Manuscripts prepared for publication will be submitted to sponsor for review and comments prior to submission to the publisher. This condition should not be construed as a means of restricting publication but is intended solely to assure mutual concurrence regarding data, evaluations, and conclusion, to provide an opportunity to share with the investigator any new and/or unpublished information of which he/she may be unaware, and to assure regulatory compliance of the results presented.
| D013568 |
| Pathological Conditions, Signs and Symptoms |