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A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat AF ablation procedures.
This study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard PVI | Active Comparator | Standard catheter ablation including pulmonary vein isolation (PVI) procedure. |
|
| FIRM-guided Procedure and PVI | Experimental | FIRM-guided procedure followed by PVI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard PVI | Procedure | Standard PVI procedure without FIRMap. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure. | Single procedure freedom from recurrence from 3-12 months post procedure | 12 months post procedure |
| Freedom From Serious Adverse Events Related to the Procedure | Freedom from any procedure-related serious adverse event from 0-10 days post procedure | 10-day post procedure |
| Freedom From Serious Adverse Events Related to the Procedure | Freedom from any procedure-related serious adverse event from 0-12 months post procedure | 12-month post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Stefan G. Spitzer, MD | Praxisklinik Herz und Gefäße Dresden, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Rhythm Research Cente | Phoenix | Arizona | 85016 | United States | ||
| Ventura Cardiology Consultants |
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In order to be randomized, subjects must have met the following criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard PVI | Standard catheter ablation including pulmonary vein isolation (PVI) procedure. Standard PVI: Standard PVI procedure without 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 |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2017 |
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| FIRM-Guided Procedure and PVI | Procedure |
|
|
| Ventura |
| California |
| 93003 |
| United States |
| Broward Health | Fort Lauderdale | Florida | 33316 | United States |
| St. Vincent's HealthCare | Jacksonville | Florida | 32216 | United States |
| Loyola University | Chicago | Illinois | 60153 | United States |
| Northwestern University - Bluhm Cardiovascular Institute | Chicago | Illinois | 60611 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Virginia Heart | Falls Church | Virginia | 22042 | United States |
| University Hospital of Antwerp | Antwerp | Flanders | Belgium |
| Klinikum Coburg | Coburg | Bavaria | Germany |
| Furth Medical Clinic for Heart and Lung Diseases | Fürth | Bavaria | Germany |
| The Dr. Müller Kliniken | Munich | Bavaria | Germany |
| Kardiologische Gemeinschaftspraxis am Park Sanssouci | Potsdam | Brandenburg | Germany |
| Kardiocentrum Frankfurt | Frankfurt | Main | Germany |
| Leipzig Heart Institute GmbH | Leipzig | Saxony | Germany |
| Luebeck University Heart Center | Lübeck | Schleswig-Holstein | Germany |
| Ruhr University Bochum - Heart and Diabetes Center North Rhine-Westphalia | Bad Oeynhausen | Germany |
| UKB (Unfallkrankenhaus Berlin) | Berlin | Germany |
| Praxisklinik Herz und Gefäße Dresden | Dresden | Germany |
| Medical Center Rotterdam (Erasmus MC) | Rotterdam | South Holland | Netherlands |
FIRM-guided procedure followed by PVI.
FIRM-Guided Procedure and PVI
| Treated | Intention to treat population. |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard PVI | Standard catheter ablation including pulmonary vein isolation (PVI) procedure. Standard PVI: Standard PVI procedure without FIRMap. |
| BG001 | FIRM-guided Procedure and PVI | FIRM-guided procedure followed by PVI. FIRM-Guided Procedure and PVI |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure. | Single procedure freedom from recurrence from 3-12 months post procedure | Intention to Treat | Posted | Count of Participants | Participants | 12 months post procedure |
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| |||||||||||||||||||||||||||||
| Primary | Freedom From Serious Adverse Events Related to the Procedure | Freedom from any procedure-related serious adverse event from 0-10 days post procedure | Intention to Treat | Posted | Count of Participants | Participants | 10-day post procedure |
|
| ||||||||||||||||||||||||||||||
| Primary | Freedom From Serious Adverse Events Related to the Procedure | Freedom from any procedure-related serious adverse event from 0-12 months post procedure | Posted | Count of Participants | Participants | 12-month post 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 | Standard PVI | Standard catheter ablation including pulmonary vein isolation (PVI) procedure. Standard PVI: Standard PVI procedure without FIRMap. | 1 | 131 | 8 | 131 | 0 | 131 |
| EG001 | FIRM-guided Procedure and PVI | FIRM-guided procedure followed by PVI. FIRM-Guided Procedure and PVI | 2 | 134 | 14 | 134 | 0 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular pseudoaneurysm | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anesthetic complication | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Arteriovenous Fistula | Vascular disorders | Non-systematic Assessment |
| ||
| Cardiac tamponade | Cardiac disorders | Non-systematic Assessment |
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| Catheter site hemorrhage | Cardiac disorders | Non-systematic Assessment |
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| Cerebral infarction | Vascular disorders | Non-systematic Assessment |
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| Cerebrovascular accident | Vascular disorders | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Dyspnea | Reproductive system and breast disorders | Non-systematic Assessment |
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| Hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Esophageal stent insertion | Gastrointestinal disorders | Non-systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
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| Peripheral artery stenosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Prostatitis | Renal and urinary disorders | Non-systematic Assessment |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Sinus node dysfunction | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Sarver, PhD | Abbott | 1-651-756-3813 | anne.sarver@abbott.com |
| Apr 8, 2024 |
| 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 |
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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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| Belgium |
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| United States |
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| Germany |
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