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| Name | Class |
|---|---|
| I-Med-Pro GmbH | OTHER |
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This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation.
FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView® mapping system. In addition to the FIRM guided ablation any other ablation method could be applied.The acute success of FIRM ablations is defined as elimination of rotors defined by absence of rotors.
Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.
Prospective and retrospective enrollment is possible.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Success | Acute Success was defined as the elimination (by ablation) of all identified rotors | day of procedure |
| Number of Participants With 12-Month Success | Single procedure freedom from atrial fibrillation recurrence | 12-months after index procedure |
| Number of Participants With Acute Safety Success | Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure | 7 days after index procedure |
| Number of Participants With 12-Month Safety Success | Success was defined as freedom from Serious Adverse 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 | Success was defined as freedom from Serious Adverse Events at 6-months after index procedure | 6-months after index procedure |
Inclusion Criteria:
reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication
Exclusion Criteria:
women who are pregnant
As this is a registry only data of patients will be included who have been treated according to the current AF guidelines.
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Subjects who are receiving a FIRM guided AF ablation and are selected in accordance with the current AF guidelines are eligible for the participation in the registry
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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 patients enrolled in the registry |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Registry Population | All patients enrolled in the 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 the elimination (by ablation) of all identified rotors | 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 | Registry Population | All patients enrolled in the registry | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent Atrial Fibrillation | Cardiac 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 |
| Repeat Procedure |
|
| Did not complete 12-month follow-up |
|
| 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 Success | Single procedure freedom from atrial fibrillation recurrence | Posted | Count of Participants | Participants | 12-months after index procedure |
|
|
|
| Primary | Number of Participants With Acute Safety Success | Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure | Posted | Count of Participants | Participants | 7 days after index procedure |
|
|
|
| Primary | Number of Participants With 12-Month Safety Success | Success was defined as freedom from Serious Adverse Events at 12-months after index procedure | Posted | Count of Participants | Participants | 12-months after index procedure |
|
|
|
| Other Pre-specified | Number of Participants With 6-Month Safety Success | Success was defined as freedom from Serious Adverse Events at 6-months after index procedure | Posted | Count of Participants | Participants | 6-months after index procedure |
|
|
|
| 299 |
| 34 |
| 299 |
| 0 |
| 299 |
| Bleeding with medical intervention | Vascular disorders | Non-systematic Assessment |
|
| Pericardial effusion | Vascular disorders | Non-systematic Assessment |
|
| Atrioesophageal fistula | Cardiac disorders | Non-systematic Assessment |
|
| Transient ischemic attack | Cardiac disorders | Non-systematic Assessment |
|
| Stroke | Vascular disorders | Non-systematic Assessment |
|
| Cardiac Resynchronization Therapy Pacemaker implantation | Surgical and medical procedures | Non-systematic Assessment |
|
| Cavotricuspid isthmus ablation | Surgical and medical procedures | Non-systematic Assessment |
|
| Dyspnea | Vascular disorders | Non-systematic Assessment |
|
| Heart rhythm disorder | Cardiac disorders | Non-systematic Assessment |
|
| High position right hemotoma | Vascular disorders | Non-systematic Assessment |
|
| Intramuscular hemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Lip laceration | Surgical and medical procedures | Non-systematic Assessment |
|
| Non-sustained ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Pacemaker implantation | Surgical and medical procedures | Non-systematic Assessment |
|
All manuscripts should be submitted to the sponsor for review and comment prior to submission to the publisher.
| D013568 |
| Pathological Conditions, Signs and Symptoms |