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The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial fibrillation (PAF). The subjects will be blinded to study treatment for the duration of the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIRM-only | Experimental | Subjects in this arm will be treated with FIRM-guided RF ablation without pulmonary vein isolation (PVI). |
|
| Conventional | Active Comparator | Subjects in this arm will undergo conventional radio frequency (RF) ablation with confirmation of PVI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIRM-guided RF ablation | Procedure |
| ||
| Conventional RF ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure | Freedom from AF/AT recurrence is defined as no documented episodes of AF/AT > 30 seconds with conventional non-invasive monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF recurrence is defined as no documented episodes of AF/AT > 30 seconds in a 72-hour window at the follow-up visits in addition to any symptomatic episodes with documented AF > 30 seconds. AT recurrence does not include episodes of cavotricuspid isthmus (CTI) dependent flutter. | 3 -12 months post study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Freedom From Procedure-related Serious Adverse Events | Freedom from procedure-related serious adverse events within one year of the index procedure | Within 1 year post study treatment |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland R. Tilz, PD Dr. med. | Universität zu Lübeck | Principal Investigator |
| Phillipp Sommer, PD Dr. med. | University of Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäres Herzzentrum Lübeck | Lübeck | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | FIRM-only | Subjects in this arm will be treated with Focal Impulse and Rotor Modulation (FIRM)-guided conventional radio frequency (RF) ablation without pulmonary vein isolation (PVI). FIRM-guided RF ablation |
| FG001 | Conventional | Subjects in this arm will undergo conventional RF ablation with confirmation of PVI. Conventional RF ablation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | FIRM-only | Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI). FIRM-guided RF ablation |
| BG001 | Conventional |
| 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 Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure | Freedom from AF/AT recurrence is defined as no documented episodes of AF/AT > 30 seconds with conventional non-invasive monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF recurrence is defined as no documented episodes of AF/AT > 30 seconds in a 72-hour window at the follow-up visits in addition to any symptomatic episodes with documented AF > 30 seconds. AT recurrence does not include episodes of cavotricuspid isthmus (CTI) dependent flutter. | Patients with 12-month follow-up data | Posted | Count of Participants | Participants | 3 -12 months post study treatment. |
|
Adverse event data was collected up to 1 year post index procedure.
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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 | FIRM-only | Subjects in this arm will be treated with FIRM-guided conventional RF ablation without pulmonary vein isolation (PVI). FIRM-guided RF ablation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
Early termination led to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Director | Abbott | 6517566717 | kristin.ruffner@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2015 | Feb 14, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2016 | Feb 14, 2019 | SAP_001.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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| Lost to Follow-up |
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| Study discontinuation |
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Subjects in this arm will undergo conventional RF ablation with confirmation of PVI.
Conventional RF ablation
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| European Heart Rhythm Association (EHRA) symptom classification in atrial fibrillation (AF) | The EHRA score considers symptoms that are attributable to AF and reverse or reduce upon restoration of sinus rhythm or with effective rate control. Classification of AF-related symptoms (EHRA score) are as follows: EHRA I - 'No symptoms' EHRA II - 'Mild symptoms'; normal daily activity not affected EHRA III - 'Severe symptoms'; normal daily activity affected EHRA IV - 'Disabling symptoms'; normal daily activity discontinued Reference:(1) Eur Heart J. 2010 (19):2369-429 | Count of Participants | Participants |
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| History of Arterial Hypertension | Count of Participants | Participants |
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| History of Coronary Artery Disease | Count of Participants | Participants |
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| History of Chronic Renal Insufficiency | Count of Participants | Participants |
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| Left Atrial Diameter | Mean | Standard Deviation | mm |
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| Anti-Arrhythmic Use at Baseline: Amiodarone | Count of Participants | Participants |
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| Anti-Arrhythmic Use at Baseline: Dronedarone | Count of Participants | Participants |
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| Anti-Arrhythmic Use at Baseline: Flecainide | Count of Participants | Participants |
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| Anti-Arrhythmic Use at Baseline: Propafenone | Count of Participants | Participants |
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| Anti-Arrhythmic Use at Baseline: Sotalol | Count of Participants | Participants |
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| OG001 | Conventional | Subjects in this arm will undergo conventional RF ablation with confirmation of PVI. Conventional RF ablation |
|
|
| Secondary | Number of Participants With Freedom From Procedure-related Serious Adverse Events | Freedom from procedure-related serious adverse events within one year of the index procedure | Subjects with 12 month safety data | Posted | Count of Participants | Participants | Within 1 year post study treatment |
|
|
|
| 0 |
| 24 |
| 12 |
| 24 |
| 4 |
| 24 |
| EG001 | Conventional | Subjects in this arm will undergo conventional RF ablation with confirmation of PVI. Conventional RF ablation | 0 | 27 | 4 | 27 | 1 | 27 |
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
|
| Accidental Exposure to Product | General disorders | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
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| Aneurysma Aorta Ascendens | Vascular disorders | Systematic Assessment |
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| Aortic Valve Stenosis | Vascular disorders | Systematic Assessment |
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| Atrial Tachycardia | Cardiac disorders | Systematic Assessment |
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| Bleeding Aneamia | Vascular disorders | Systematic Assessment |
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| Blood Sodium Decreased | Metabolism and nutrition disorders | Systematic Assessment |
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| Carotid Artery Stenosis | Vascular disorders | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | Systematic Assessment |
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| Cerebral Infarction | Vascular disorders | Systematic Assessment |
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| Chondromatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Coronary Artery Disease | Vascular disorders | Systematic Assessment |
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| Femoral Artery Occlusion | Vascular disorders | Systematic Assessment |
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| Femoral Artery Aneurysm | Vascular disorders | Systematic Assessment |
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| Fracture Of Distale Radius Left, Orbita And Maxillary Sinus | General disorders | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Haematoma, Injection Site | Vascular disorders | Systematic Assessment |
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| Haematoma, Right Groin | Vascular disorders | Systematic Assessment |
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| Liver Abscess | Hepatobiliary disorders | Systematic Assessment |
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| Phrenic Nerve Paralysis | Nervous system disorders | Systematic Assessment |
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| Occlusion Of Arteria Femoralis Pop-Iii-Bypass Right Side | Vascular disorders | Systematic Assessment |
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| Peripheral Ischaemia | Vascular disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Syncope | Vascular disorders | Systematic Assessment |
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| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Suspected Dementia With Hospitalisation Due To Diagnostic Tests | Psychiatric disorders | Systematic Assessment |
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The data and results from this study are the sole property of Sponsor. Investigators will not use data from this clinical investigation without the written consent of the Sponsor or generate publication materials as referenced in the Clinical Trial Agreement Single-center results are not allowed to be published or presented before the multi-center results.
| D013568 |
| Pathological Conditions, Signs and Symptoms |