Trial Outcomes & Findings for A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter (NCT NCT04983797)
NCT ID: NCT04983797
Last Updated: 2023-07-03
Results Overview
Number of participants with SAEs within 7 days of index procedure related to the OPTRELL catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Up to 7 days of index procedure at Day 0
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
OPTRELL Mapping Catheter
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 14.40 • n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days of index procedure at Day 0Population: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
Number of participants with SAEs within 7 days of index procedure related to the OPTRELL catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
Number of participants with pre-ablation mapping and clinically indicated mapping performed with the OPTRELL catheter without resort to other mapping catheters were reported.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters
|
31 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days of index procedure at Day 0Population: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
Number of participants with SAEs within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Participants With SAEs Within 7 Days of Index Procedure
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days of index procedure at Day 0Population: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
Number of participants with non-serious adverse events within 7 days of index procedure associated with the use of the OPTRELL catheter were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for maneuverability \& handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability \& handling.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Ventricle): Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Ventricle): Score 4
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Ventricle): Score 5
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Ventricle): Score 6
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Ventricle): Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Ventricle): Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Ventricle): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Ventricle): Score 6
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Ventricle): Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Atrium): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Atrium): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Atrium): Score 6
|
6 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Atrium): Score 7
|
17 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Atrium): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Atrium): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Atrium): Score 6
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Atrium): Score 7
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Ventricle): Score 4
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Ventricle): Score 5
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Ventricle): Score 6
|
5 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Left Ventricle): Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Ventricle): Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Ventricle): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Ventricle): Score 6
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Deploy (Right Ventricle): Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Atrium): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Atrium): Score 5
|
7 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Atrium): Score 6
|
7 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Atrium): Score 7
|
9 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Atrium): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Atrium): Score 5
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Atrium): Score 6
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Atrium): Score 7
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Ventricle): Score 4
|
5 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Ventricle): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Ventricle): Score 6
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Left Ventricle): Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Ventricle): Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Ventricle): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Ventricles): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Atrium): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Atrium): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Atrium): Score 6
|
8 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Atrium): Score 7
|
15 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Atrium): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Atrium): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Atrium): Score 6
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Atrium): Score 7
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Ventricle): Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Ventricle): Score 5
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Ventricle): Score 6
|
5 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Left Ventricle): Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Ventricle): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Ventricle): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Ventricle): Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Ventricle): Score 6
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Maneuver (Right Ventricle): Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Atrium): Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Atrium): Score 5
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Atrium): Score 6
|
12 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Atrium): Score 7
|
6 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Atrium): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Atrium): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Atrium): Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Atrium): Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Atrium): Score 5
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Atrium): Score 6
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Right Atrium): Score 7
|
3 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Ventricle): Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Reach Areas (Left Ventricle): Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Ventricle): Score 6
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Ability to Withdraw (Right Ventricle): Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Insertion/ Withdrawal from Introducer Sheath: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Insertion/ Withdrawal from Introducer Sheath: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Insertion/ Withdrawal from Introducer Sheath: Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Insertion/ Withdrawal from Introducer Sheath: Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Insertion/ Withdrawal from Introducer Sheath: Score 5
|
9 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Insertion/ Withdrawal from Introducer Sheath: Score 6
|
9 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Insertion/ Withdrawal from Introducer Sheath: Score 7
|
10 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Learning Curve: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Learning Curve: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Learning Curve: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Learning Curve: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Learning Curve: Score 5
|
4 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Learning Curve: Score 6
|
18 Participants
|
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Learning Curve: Score 7
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for signal collection and quality were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 5
|
3 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 6
|
12 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 7
|
15 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atrium: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atrium: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atrium: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atrium: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atrium: Score 5
|
1 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atrium: Score 6
|
4 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Atrium: Score 7
|
2 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricle: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricle: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricle: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricle: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricle: Score 5
|
3 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricle: Score 6
|
4 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR signals in Ventricle: Score 7
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 5
|
4 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 6
|
7 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
UNIPOLAR noise encountered: Score 7
|
4 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atrium: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atrium: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atrium: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atrium: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atrium: Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atrium: Score 6
|
7 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Atrium: Score 7
|
16 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricle: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricle: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricle: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricle: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricle: Score 5
|
1 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricle: Score 6
|
7 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR signals in Ventricle: Score 7
|
1 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Signal Collection and Quality
BIPOLAR noise encountered: Score 4
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for pacing (local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=9 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 7
|
3 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 3
|
1 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 5
|
2 Participants
|
|
Number of Responders for Physician Assessment for Pacing
Local pacing capture: Score 6
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
Number of responders for physician assessment for catheter design were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter design in OPTRELL catheter for mapping.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Ability to achieve electrode contact with cardiac tissue: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Ability to achieve electrode contact with cardiac tissue: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Ability to achieve electrode contact with cardiac tissue: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Ability to achieve electrode contact with cardiac tissue: Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Ability to achieve electrode contact with cardiac tissue: Score 5
|
2 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Ability to achieve electrode contact with cardiac tissue: Score 6
|
18 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Ability to achieve electrode contact with cardiac tissue: Score 7
|
8 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrodes spacing: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrodes spacing: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrodes spacing: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrodes spacing: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrodes spacing: Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrodes spacing: Score 6
|
13 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrodes spacing: Score 7
|
17 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrode array coverage: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrode array coverage: Score 2
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrode array coverage: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrode array coverage: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrode array coverage: Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrode array coverage: Score 6
|
9 Participants
|
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Electrode array coverage: Score 7
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for workflow were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for workflow.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 4
|
10 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 5
|
6 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 6
|
10 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to reduce fluoroscopy: Score 7
|
5 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 4
|
8 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 5
|
4 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 6
|
10 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for pre-procedure mapping: Score 7
|
9 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 5
|
4 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 6
|
9 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Time for post-procedure mapping after standard of care ablation: Score 7
|
9 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 6
|
13 Participants
|
|
Number of Responders for Physician Assessment for Workflow
Ability to identify targets: Score 7
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
Number of responders for physician assessment for catheter visualization were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter visualization.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 5
|
7 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 6
|
9 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization under fluoroscopy: Score 7
|
15 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 5
|
3 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 6
|
10 Participants
|
|
Number of Responders for Physician Assessment for Catheter Visualization
Visualization in CARTO 3: Score 7
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. Here, 'n' (number analyzed) is defined as participants analyzed for specified categories.
Number of responders for physician assessment for catheters interactions were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheters interactions.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Responders for Physician Assessment for Catheters Interactions
With CARTO 3 System: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
With CARTO 3 System: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
With CARTO 3 System: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
With CARTO 3 System: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
With CARTO 3 System: Score 5
|
4 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
With CARTO 3 System: Score 6
|
12 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
With CARTO 3 System: Score 7
|
15 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 5
|
8 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 6
|
12 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
EP Lab recording equipment: Score 7
|
10 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 5
|
4 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 6
|
3 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Pacing equipment: Score 7
|
7 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 4
|
3 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 5
|
6 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 6
|
14 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Introducer tool on catheter: Score 7
|
8 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 4
|
3 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 5
|
6 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 6
|
14 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Sheath: Score 7
|
8 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 5
|
5 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 6
|
15 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
Irrigation bag and tubing: Score 7
|
11 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 4
|
1 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 5
|
2 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 6
|
2 Participants
|
|
Number of Responders for Physician Assessment for Catheters Interactions
ICD or other implantable devices: Score 7
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. Here, 'n' (number analyzed) signifies number of participants evaluable at specified categories.
Number of responders with physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter?: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter?: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter?: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter?: Score 4
|
2 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter?: Score 5
|
5 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter?: Score 6
|
10 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to the PENTARAY catheter?: Score 7
|
14 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters?: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters?: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters?: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters?: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters?: Score 5
|
5 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters?: Score 6
|
19 Participants
|
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Compared to other competitive multielectrode catheters?: Score 7
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at specified categories.
Number of responders for physician assessment for design and coverage for confirming PVI were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for design and coverage for confirming PVI.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=21 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to the PENTARAY catheter?: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to the PENTARAY catheter?: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to the PENTARAY catheter?: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to the PENTARAY catheter?: Score 4
|
3 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to the PENTARAY catheter?: Score 5
|
2 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to the PENTARAY catheter?: Score 6
|
7 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to the PENTARAY catheter?: Score 7
|
9 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to other competitive multielectrode catheters?: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to other competitive multielectrode catheters?: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to other competitive multielectrode catheters?: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to other competitive multielectrode catheters?: Score 4
|
4 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to other competitive multielectrode catheters?: Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to other competitive multielectrode catheters?: Score 6
|
13 Participants
|
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Compared to other competitive multielectrode catheters?: Score 7
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 72 daysPopulation: The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter. Here, 'n' (number analyzed) signifies number of participants evaluable at specified categories.
Number of responders for physician assessment for ability to characterize the tissue were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to characterize the tissue.
Outcome measures
| Measure |
OPTRELL Mapping Catheter
n=31 Participants
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter?: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter?: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter?: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter?: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter?: Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter?: Score 6
|
16 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to the PENTARAY catheter?: Score 7
|
15 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters?: Score 1
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters?: Score 2
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters?: Score 3
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters?: Score 4
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters?: Score 5
|
0 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters?: Score 6
|
25 Participants
|
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Compared to other competitive multielectrode catheters?: Score 7
|
0 Participants
|
Adverse Events
OPTRELL Mapping Catheter
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPTRELL Mapping Catheter
n=31 participants at risk
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
|
General disorders
Catheter site injury
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
|
Vascular disorders
Peripheral artery haematoma
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
Other adverse events
| Measure |
OPTRELL Mapping Catheter
n=31 participants at risk
Participants diagnosed with cardiac arrhythmias who were scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for Atrial and ventricular procedures used multi-electrode OPTRELL mapping catheter for pre-ablation mapping.
|
|---|---|
|
Cardiac disorders
Left ventricular dilatation
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
|
Cardiac disorders
Left ventricular dysfunction
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
|
General disorders
Fatigue
|
6.5%
2/31 • Number of events 2 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
|
Infections and infestations
Ear infection
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
|
Nervous system disorders
Paraesthesia
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
|
Psychiatric disorders
Anxiety disorder
|
3.2%
1/31 • Number of events 1 • Up to 72 days
The safety analysis set consisted of all enrolled participants who had undergone insertion of the study catheter.
|
Additional Information
Associate Director Medical Affairs
Biosense Webster, Inc.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER