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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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The purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Robot | Experimental | device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amigo catheter robot | Device | The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Navigation Performance | Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects. | During Procedure |
| Evaluation of Major Complications | Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up. | Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals. |
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Inclusion Criteria:
Exclusion Criteria:
Any contraindication to cardiac catheterization, including pregnancy.
Enrollment in any other ongoing cardiac device trial.
Right-sided cardiac prosthetics including implanted active energy devices with permanent leads in or through the right atrium and/or ventricle.
Corrected or uncorrected atrial septal defect (ASD).
Poor general health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, mental capacity, etc.).
Medical condition that will require anticoagulation during study or ablation procedure.
Presence of atrial fibrillation or atrial flutter at time of study procedure.
Other condition observed prior to the procedure where, in the view of the physician, participation in the study could further present a risk to the subject.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658 | United States | ||
| Sequoia Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23636870 | Derived | Khan EM, Frumkin W, Ng GA, Neelagaru S, Abi-Samra FM, Lee J, Giudici M, Gohn D, Winkle RA, Sussman J, Knight BP, Berman A, Calkins H. First experience with a novel robotic remote catheter system: Amigo mapping trial. J Interv Card Electrophysiol. 2013 Aug;37(2):121-9. doi: 10.1007/s10840-013-9791-9. Epub 2013 May 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intent-to-Treat | Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS. Amigo RCS is an accessory for use in the cardiac EP setting to allow the operator to manipulate a steerable cardiac catheter and perform a conventional electrophysiology procedure. The intent of the device is to allow the operator to complete the procedure in a conventional x-ray guided EP lab. Catheter control can be performed while standing (or sitting) some distance from the subject to minimize absorbed radiology dose and minimize operator fatigue from standing for long periods of time with the standard lead aprons/personal protection devices. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Redwood City |
| California |
| 94062 |
| United States |
| Northwestern Medical Center | Chicago | Illinois | 60611 | United States |
| Genesis Health, | Davenport | Iowa | 52803 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Gagnon Cardiovascular Institute/Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Lancaster Heart & Stroke Foundation | Lancaster | Pennsylvania | 17602 | United States |
| Lone Star Heart Center | Amarillo | Texas | 79106 | United States |
| Valley Health | Winchester | Virginia | 22601 | United States |
| Glenfield Hospital | Leicester | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intent-to-Treat | Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS. |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Navigation Performance | Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects. | Posted | Number | 95% Confidence Interval | Successful locations | During Procedure | Locations | Participants |
|
|
| ||||||||||||||||||||||||||
| Primary | Evaluation of Major Complications | Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up. | Posted | Number | 95% Confidence Interval | Participants | Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals. |
|
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Evaluation of adverse events definitely or probably related to Amigo RCS controlled mapping through 7 day follow-up.
Only adverse events related to the device are posted
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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 | Intent-to-Treat | Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS. | 0 | 181 | 1 | 181 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Tachycardia | Cardiac disorders | Systematic Assessment | Subject experienced SVT during mapping with Amigo. Attempts were made to terminate arrhythmia but a right bundle morphology was seen for the rest of the procedure. The CEC adjudicated the event as non serious, minor and probably related to device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical and Regulatory Affairs | Catheter Robotics, Inc. | 973-426-0300 | research@catheterrobotics.com |
| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
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