Trial Outcomes & Findings for Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus (NCT NCT02467179)
NCT ID: NCT02467179
Last Updated: 2019-06-27
Results Overview
Determination of the average total contact force (measured in gs) achieved during each ablation lesion using the Carto Mapping System
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
At time of the ablation procedure, which typically lasts 30-60 minutes
Results posted on
2019-06-27
Participant Flow
Participant milestones
| Measure |
Manual Catheter Manipulation
25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.
Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to manual catheter manipulation.
|
Amigo™ Robotic Catheter Manipulation
25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.
Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to robotic catheter manipulation.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Manual Catheter Manipulation
n=25 Participants
25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.
Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to manual catheter manipulation.
|
Amigo™ Robotic Catheter Manipulation
n=25 Participants
25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.
Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to robotic catheter manipulation.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 12 • n=25 Participants
|
63 years
STANDARD_DEVIATION 12 • n=25 Participants
|
63 years
STANDARD_DEVIATION 12 • n=50 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
14 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
36 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
PRIMARY outcome
Timeframe: At time of the ablation procedure, which typically lasts 30-60 minutesDetermination of the average total contact force (measured in gs) achieved during each ablation lesion using the Carto Mapping System
Outcome measures
| Measure |
Manual Catheter Manipulation
n=25 Participants
25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.
Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to manual catheter manipulation.
|
Amigo™ Robotic Catheter Manipulation
n=25 Participants
25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.
Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to robotic catheter manipulation.
|
|---|---|---|
|
Contact Force Through Measurement of Force-time Integral (FTI)
|
471 gm/s
Standard Deviation 179
|
571 gm/s
Standard Deviation 278
|
SECONDARY outcome
Timeframe: at time of ablation procedureDetermine fluoroscopy time to reach CTI block.
Outcome measures
| Measure |
Manual Catheter Manipulation
n=25 Participants
25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.
Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to manual catheter manipulation.
|
Amigo™ Robotic Catheter Manipulation
n=25 Participants
25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.
Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to robotic catheter manipulation.
|
|---|---|---|
|
Fluoroscopy Time Measurements
|
3.8 minutes
Standard Deviation 2.3
|
6.8 minutes
Standard Deviation 4.4
|
Adverse Events
Manual Catheter Manipulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amigo™ Robotic Catheter Manipulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place