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The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart).
Subjects who satisfy the inclusion and exclusion criteria will be treated with an RF ablation catheter and Artisan guide catheters controlled by the Sensei X Robotic Catheter System.
Subject will be followed for a period of one year post ablation procedure.
Follow up visit time frames will be conducted at 7-day, 30-day, 90-day, 180-day and 365-day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic catheter manipulation, Ablation | Experimental | To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Device | Atrial fibrillation ablation procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety-Incidence of Major Complications | The primary safety endpoint was defined as the incidence of major complications, including all early onset (within 7 days of the ablation procedure) major complications, and the incidence of esophageal injury or pulmonary vein stenosis through 180 days. | within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days |
| Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes | The primary effectiveness endpoint is chronic success as demonstrated by the freedom from symptomatic atrial arrhythmia from days 91 to 365. | 91 - 365 days after the inital ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Procedural Success | Acute procedural success is defined as the successful ablation of at least three of four pulmonary veins as shown by pulmonary vein entrance block per vein during the initial ablation procedure. A subject is considered to be an acute procedural failure if acute procedural success cannot be obtained by using the Hansen system and, as a result, manual manipulation is needed to complete the ablation procedure with the ablation catheter. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Gallinghouse, M.D. | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Andrea Natale, M.D. | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Brenda Cayme, RN., BSN | Hansen Medical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Heart Hospital | Mesa | Arizona | 85206 | United States | ||
| Mayo Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Robotic Catheter Manipulation, Ablation | To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation. |
| 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 | Yes | No | No | Study Protocol | Dec 11, 2014 | Aug 14, 2018 |
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| Day 0 |
| Chronic Safety-Incidence of Major Complications | Chronic safety is defined as the incidence of Major Complications during the period from 8 - 365 days following the initial ablation procedure (excluding pulmonary vein stenosis and atrio-esophageal fistula from 8 - 180 days, which are included in the primary safety endpoint). The incidence of pulmonary vein stenosis and atrioesophageal fistula is included during the period from 181 - 365 days. | 8 - 365 days post-procedure |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Saint Barnabas Heart Center | Livingston | New Jersey | 07039 | United States |
| Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Texas Health Arlington Memorial/Heart Place | Arlington | Texas | 76012 | United States |
| Texas Cardiac Arrhythmia Research Foundation (TCARF) | Austin | Texas | 78705 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| Univeristy of Virginia | Charlottesville | Virginia | 22908 | United States |
| IKEM, Dept of Cardiology | Prague | Czechia |
| Gentofte University Hospital | Hellerup | 2900 | Denmark |
| Hospital Universitario Madrid MonteprÃncipe | Madrid | Spain |
| John Radcliff Hospital | Oxford | OX39DU | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic Catheter Manipulation, Ablation | To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Safety-Incidence of Major Complications | The primary safety endpoint was defined as the incidence of major complications, including all early onset (within 7 days of the ablation procedure) major complications, and the incidence of esophageal injury or pulmonary vein stenosis through 180 days. | Posted | Count of Participants | Participants | within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days |
|
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| |||||||||||||||||||||||||||||||
| Primary | Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes | The primary effectiveness endpoint is chronic success as demonstrated by the freedom from symptomatic atrial arrhythmia from days 91 to 365. | Posted | Count of Participants | Participants | 91 - 365 days after the inital ablation procedure |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Acute Procedural Success | Acute procedural success is defined as the successful ablation of at least three of four pulmonary veins as shown by pulmonary vein entrance block per vein during the initial ablation procedure. A subject is considered to be an acute procedural failure if acute procedural success cannot be obtained by using the Hansen system and, as a result, manual manipulation is needed to complete the ablation procedure with the ablation catheter. | Posted | Count of Participants | Participants | Day 0 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Chronic Safety-Incidence of Major Complications | Chronic safety is defined as the incidence of Major Complications during the period from 8 - 365 days following the initial ablation procedure (excluding pulmonary vein stenosis and atrio-esophageal fistula from 8 - 180 days, which are included in the primary safety endpoint). The incidence of pulmonary vein stenosis and atrioesophageal fistula is included during the period from 181 - 365 days. | Posted | Count of Participants | Participants | 8 - 365 days post-procedure |
|
|
Adverse event data were collected one year following the 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 | Robotic Catheter Manipulation, Ablation | To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation. | 0 | 150 | 28 | 150 | 34 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Heart block | Cardiac disorders | Systematic Assessment |
| ||
| Perforation of the cardiac muscle | Cardiac disorders | Systematic Assessment |
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| Pericarditis | Cardiac disorders | Systematic Assessment |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bleeding (requiring treatment other than applying pressure & bandage) | Vascular disorders | Systematic Assessment |
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| Pseudoaneurysm | Vascular disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Benign prostatic hypertrophy | Reproductive system and breast disorders | Systematic Assessment |
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| Arrhytmia Prophylaxis | Cardiac disorders | Systematic Assessment |
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| Atrial fibrilation | Cardiac disorders | Systematic Assessment |
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| Cardiac ablation | Cardiac disorders | Systematic Assessment |
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| Fluid overload | Vascular disorders | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | Systematic Assessment |
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| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Pharyngeal haematoma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Retroperitoneal haematoma | Vascular disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
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Following the acquisition of Hansen, a decision was made to terminate the study. The PMA previously planned to be submitted year end 2016 will not be submitted.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emir Deljkich/Sr. Director, Clinical Affairs | Auris Health, Inc. | 650-397-2677 | emir.deljkich@aurisrobotics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2013 | Aug 14, 2018 | SAP_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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| 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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