Trial Outcomes & Findings for Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (NCT NCT02130765)
NCT ID: NCT02130765
Last Updated: 2019-02-12
Results Overview
Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
12 months
Results posted on
2019-02-12
Participant Flow
Participant milestones
| Measure |
Randomized Subjects-Ablation
Enrolled subjects who meet entry criteria and are randomized to the ablation group (Subjects to receive ablation therapy for ventricular tachycardia using the FlexAbility(TM) Ablation Catheter System in addition to routine drug therapy)
|
Randomized Subjects- Control
Enrolled subjects who meet entry criteria and are randomized to the control group (Subjects to receive routine drug therapy)
|
Registry Subjects
Enrolled subjects who do not meet entry criteria (specifically noninvasive programmed stimulation \[NIPS\] or electrophysiology \[EP\] study without monomorphic ventricular tachycardia \[MMVT\] and absence of spontaneous documented MMVT).
|
Early Withdrawal Subjects
Subjects enrolled but withdrawn early from the study
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
26
|
19
|
|
Overall Study
COMPLETED
|
7
|
8
|
26
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Randomized Subjects-Ablation
Enrolled subjects who meet entry criteria and are randomized to the ablation group (Subjects to receive ablation therapy for ventricular tachycardia using the FlexAbility(TM) Ablation Catheter System in addition to routine drug therapy)
|
Randomized Subjects- Control
Enrolled subjects who meet entry criteria and are randomized to the control group (Subjects to receive routine drug therapy)
|
Registry Subjects
Enrolled subjects who do not meet entry criteria (specifically noninvasive programmed stimulation \[NIPS\] or electrophysiology \[EP\] study without monomorphic ventricular tachycardia \[MMVT\] and absence of spontaneous documented MMVT).
|
Early Withdrawal Subjects
Subjects enrolled but withdrawn early from the study
|
|---|---|---|---|---|
|
Overall Study
Did not receive treatment
|
4
|
0
|
0
|
0
|
Baseline Characteristics
Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia
Baseline characteristics by cohort
| Measure |
Randomized Subjects-Ablation
n=11 Participants
|
Randomized Subjects-Control
n=8 Participants
|
Registry Subjects
n=26 Participants
|
Early Withdrawal Subjects
n=19 Participants
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 15.0 • n=4 Participants
|
60.9 years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
21 participants
n=5 Participants
|
17 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
1 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
7 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPrimary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up
Outcome measures
| Measure |
Randomized Subjects-Ablation
n=7 Participants
Enrolled subjects who meet entry criteria and are randomized to the ablation group (Subjects to receive ablation therapy for ventricular tachycardia using the FlexAbility(TM) Ablation Catheter System in addition to routine drug therapy)
|
Randomized Subjects- Control
n=8 Participants
Enrolled subjects who meet entry criteria and are randomized to the control group (Subjects to receive routine drug therapy)
|
Registry Subjects
n=26 Participants
Enrolled subjects who do not meet entry criteria (specifically NIPS or EP Study without MMVT and absence of spontaneous documented MMVT).
|
Early WIthdrawal Subjects
n=19 Participants
Subjects enrolled but withdrawn early from the study
|
|---|---|---|---|---|
|
Number of Subjects Who Experienced an ICD Shock Event.
|
1 Participants
|
1 Participants
|
0 Participants
|
NA Participants
Primary effectiveness data not collected in early withdrawal subjects
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 4 subjects randomized to treatment arm but did not receive ablation (not treated) and therefore excluded from analysis.
Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.
Outcome measures
| Measure |
Randomized Subjects-Ablation
n=7 Participants
Enrolled subjects who meet entry criteria and are randomized to the ablation group (Subjects to receive ablation therapy for ventricular tachycardia using the FlexAbility(TM) Ablation Catheter System in addition to routine drug therapy)
|
Randomized Subjects- Control
n=8 Participants
Enrolled subjects who meet entry criteria and are randomized to the control group (Subjects to receive routine drug therapy)
|
Registry Subjects
n=26 Participants
Enrolled subjects who do not meet entry criteria (specifically NIPS or EP Study without MMVT and absence of spontaneous documented MMVT).
|
Early WIthdrawal Subjects
n=19 Participants
Subjects enrolled but withdrawn early from the study
|
|---|---|---|---|---|
|
Number of Subjects Who Experienced a Select Serious Adverse Event
|
2 Participants
|
NA Participants
Primary safety events not measured in this arm because events required to be related to catheter ablation
|
NA Participants
Primary safety events not measured in this arm because events required to be related to catheter ablation
|
NA Participants
Primary safety events not measured in this arm because events required to be related to catheter ablation
|
SECONDARY outcome
Timeframe: 12 monthsNumber of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.
Outcome measures
| Measure |
Randomized Subjects-Ablation
n=7 Participants
Enrolled subjects who meet entry criteria and are randomized to the ablation group (Subjects to receive ablation therapy for ventricular tachycardia using the FlexAbility(TM) Ablation Catheter System in addition to routine drug therapy)
|
Randomized Subjects- Control
n=8 Participants
Enrolled subjects who meet entry criteria and are randomized to the control group (Subjects to receive routine drug therapy)
|
Registry Subjects
n=26 Participants
Enrolled subjects who do not meet entry criteria (specifically NIPS or EP Study without MMVT and absence of spontaneous documented MMVT).
|
Early WIthdrawal Subjects
n=19 Participants
Subjects enrolled but withdrawn early from the study
|
|---|---|---|---|---|
|
Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
All Enrolled Subjects
Serious events: 9 serious events
Other events: 4 other events
Deaths: 1 deaths
Randomized Subjects- Ablation
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Randomized Subjects-Control
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Registry Subjects
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Early Withdrawal Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Enrolled Subjects
n=64 participants at risk
All Enrolled Subjects
|
Randomized Subjects- Ablation
n=11 participants at risk
Enrolled subjects who meet entry criteria and are randomized to the ablation group (Subjects to receive ablation therapy for ventricular tachycardia using the FlexAbility (TM) Ablation Catheter System in addition to routine drug therapy).
|
Randomized Subjects-Control
n=8 participants at risk
Enrolled subjects who meet entry criteria and are randomized to the control group (Subjects to receive routine drug therapy).
|
Registry Subjects
n=26 participants at risk
Enrolled subjects who do not meet entry criteria (specifically noninvasive programmed stimulation \[NIPS\] or electrophysiology \[EP\] study without monomorphic ventricular tachycardia \[MMVT\] and absence of spontaneous documented MMVT).
|
Early Withdrawal Subjects
n=19 participants at risk
Subjects enrolled but withdrawn early from the study.
|
|---|---|---|---|---|---|
|
Infections and infestations
Acute Bacterial Endocarditis
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
9.1%
1/11 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Cardiac disorders
Atrial Fibrillation
|
3.1%
2/64 • Number of events 2
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/11
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
12.5%
1/8 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
3.8%
1/26 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Cardiac disorders
Congestive Heart Failure
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/11
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
3.8%
1/26 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
9.1%
1/11 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Cardiac disorders
Elevated Thresholds
|
3.1%
2/64 • Number of events 2
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
18.2%
2/11 • Number of events 2
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Vascular disorders
Peripheral Arterial Occlusion
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
9.1%
1/11 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/11
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
12.5%
1/8 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Cardiac disorders
Premature Ventricular Contraction
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
9.1%
1/11 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Cardiac disorders
Regular Narrow QRS Tachycardia/Supraventricular Tachycardia
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
9.1%
1/11 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Cardiac disorders
Sustained Ventricular Tachycardia
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
9.1%
1/11 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
Other adverse events
| Measure |
All Enrolled Subjects
n=64 participants at risk
All Enrolled Subjects
|
Randomized Subjects- Ablation
n=11 participants at risk
Enrolled subjects who meet entry criteria and are randomized to the ablation group (Subjects to receive ablation therapy for ventricular tachycardia using the FlexAbility (TM) Ablation Catheter System in addition to routine drug therapy).
|
Randomized Subjects-Control
n=8 participants at risk
Enrolled subjects who meet entry criteria and are randomized to the control group (Subjects to receive routine drug therapy).
|
Registry Subjects
n=26 participants at risk
Enrolled subjects who do not meet entry criteria (specifically noninvasive programmed stimulation \[NIPS\] or electrophysiology \[EP\] study without monomorphic ventricular tachycardia \[MMVT\] and absence of spontaneous documented MMVT).
|
Early Withdrawal Subjects
n=19 participants at risk
Subjects enrolled but withdrawn early from the study.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/11
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
12.5%
1/8 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Cardiac disorders
Atrial Flutter
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/11
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
12.5%
1/8 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/11
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
3.8%
1/26 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
General disorders
Dizziness
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
9.1%
1/11 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Reproductive system and breast disorders
Erectile Dysfunction Symptoms
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
9.1%
1/11 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/8
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
|
Vascular disorders
Vascular Hematoma
|
1.6%
1/64 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/11
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
12.5%
1/8 • Number of events 1
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/26
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
0.00%
0/19
Adverse event reporting occurred from the time of subject enrollment (time of signed informed consent) through subject's completion in the study, subject withdrawal, early study termination, or otherwise discontinuation from the study. Therefore adverse events are reported for all 64 enrolled subjects including all randomized subjects, registry subjects, and early withdrawal subjects for the duration of time each subject was enrolled in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place