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The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard PVI Ablation | Active Comparator | Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF. |
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| FIRM-guided Procedure and PVI | Experimental | FIRM-guided procedure followed by standard catheter ablation including PVI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard PVI Ablation | Procedure | Standard PVI procedure without FIRMap. |
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| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure | Within 7-10 days of the Procedure | |
| Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure. | 3-month follow up | |
| Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure. | 3-12 months post study treatment | |
| Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure | 3 to 12 months post study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts | Immediately post procedure |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Brachmann, MD | Klinikum Coburg GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Rhythm Center | Phoenix | Arizona | 85013 | United States | ||
| Hoag Memorial Hospital Presbyterian |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard PVI Ablation | Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent atrial fibrillation (AF). Standard PVI Ablation: Standard PVI procedure without Focal Impulse and Rotor Modulation Mapping Catheter (FIRMap). |
| FG001 | FIRM-guided Procedure and PVI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2014 | Dec 19, 2019 |
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| FIRM-Guided Procedure and PVI | Procedure | FIRM-guided procedure followed by conventional ablation including PVI. |
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| Newport Beach |
| California |
| 92658 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana University - Krannert Institute of Cardiology | Indianapolis | Indiana | 46202 | United States |
| St. Vincent Hospital | Indianapolis | Indiana | 46260 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | United States |
| Hackensack UMC | Hackensack | New Jersey | United States |
| Weill Medical College at Cornell University | New York | New York | 10065 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | United States |
| Herz- und Diabeteszentrum Bad Oeynhausen | Bad Oeynhausen | Minden-Lübbecke | 32545 | Germany |
| Unfallkrankenhaus Berlin | Berlin | 12683 | Germany |
| Klinikum Coburg GmbH | Coburg | 96450 | Germany |
| Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR | Dresden | 01099 | Germany |
| Städtisches Klinikum Karlsruhe gGmbH | Karlsruhe | Germany |
| Leipzig Heart Institute GmbH | Leipzig | 04289 | Germany |
| Kardiologische Gemeinschaftspraxis am Park Sanssouci | Potsdam | 14471 | Germany |
| Erasmus Medical Center | Rotterdam | Netherlands |
Focal Impulse and Rotor Modulation (FIRM)-guided procedure followed by standard catheter ablation including PVI. FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI. |
| Completed Per Protocol | Per protocol are subjects in ITT group who completed all follow-ups with no major deviations. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard PVI Ablation | Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF. Standard PVI Ablation: Standard PVI procedure without FIRMap. |
| BG001 | FIRM-guided Procedure and PVI | FIRM-guided procedure followed by standard catheter ablation including PVI. FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| NYHA Classification | 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. | Number | category |
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| Largest Left Atrial Diameter | Mean | Standard Deviation | mm |
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| LV Ejection Fraction | Mean | Standard Deviation | % |
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| Prior and concomitant antiarrhythmic drugs (AAD) | Prior and concomitant use of AADs refers to the types of pharmacological therapies a participant has been on or is on in order to treat their arrhythmia. Participants may be on more than one type of AAD. Class 1 AAD = Sodium Channel Blockers Class 2 AAD = Beta-Adrenoceptor Antagonist Class 3 AAD = Potassium Channel Blockers Class 4 AAD = Calcium Channel Blockers | Number | participants |
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| Hospitalizations for Cardiac Arrhythmias within 6 months of screening | Count of Participants | Participants |
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| Treated for atrial fibrillation in the 6 months prior to enrollment | Number | % |
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| History of significant past and/or concomitant diseases or past surgeries | Number | % |
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| Subjects that had LV Ejection Fraction Measured | Count of Participants | Participants |
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| 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 | Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure | Intent to Treat (ITT) group, defined as subject randomized to a treatment group who had a mapping and/or ablation catheter inserted | Posted | Number | % of participants | Within 7-10 days of the Procedure |
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| Primary | Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure. | ITT: each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted Per Protocol: those subjects in the ITT group who completed all follow-up visits and had no major protocol deviations | Posted | Number | % of participants | 3-month follow up |
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| Primary | Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure. | ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted | Posted | Number | % of participants | 3-12 months post study treatment |
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| Primary | Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure | ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted | Posted | Count of Participants | Participants | 3 to 12 months post study treatment |
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| Secondary | Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts | ITT | Posted | Number | 95% Confidence Interval | % of participants | Immediately post procedure |
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1 year
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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 | Standard PVI Ablation | Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF. Standard PVI Ablation: Standard PVI procedure without FIRMap. | 1 | 179 | 19 | 179 | 0 | 179 |
| EG001 | FIRM-guided Procedure and PVI | FIRM-guided procedure followed by standard catheter ablation including PVI. FIRM-Guided Procedure and PVI: FIRM-guided procedure followed by conventional ablation including PVI. | 2 | 171 | 28 | 171 | 0 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Arteriovenous fistula operation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
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| C-reactive protein increased | General disorders | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Cerebrovascular accident | Vascular disorders | Systematic Assessment |
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| Fluid overload | Cardiac disorders | Systematic Assessment |
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| Gastroparesis postoperative | Gastrointestinal disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Pericarditis | Cardiac disorders | Systematic Assessment |
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| Pericarditis infective | Cardiac disorders | Systematic Assessment |
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| Pericardial disease | Cardiac disorders | Systematic Assessment |
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| Pericardial hemmorrhage | Cardiac disorders | Systematic Assessment |
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| Peritoneal hemorrhage | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | Systematic Assessment |
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| Vessel puncture site hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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All manuscripts should be submitted to the sponsor for review and comment prior to submission to the publisher.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Program Director | Abbott | 651-756-6717 | kristin.ruffner@abbott.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 17, 2014 | Dec 19, 2019 | Prot_001.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 |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Germany |
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| Class II |
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| Class III |
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| Class 2 AAD |
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| Class 3 AAD |
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| Class 4 AAD |
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| CNS/Neurological |
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| Dermatologic |
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| Drug Allergy |
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| Endocrine/Metabolic |
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| Eyes/Ears/Nose/Throat |
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| Gastrointestinal |
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| Genitourinary |
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| Hematologic |
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| Hepatic |
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| Immunological |
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| Malignancy |
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| Musculoskeletal |
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| Psychiatric |
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| Renal |
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| Respiratory |
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| Other |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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