Trial Outcomes & Findings for EGM Analysis in Idiopathic Outflow Tract Ventricular Arrhythmia (NCT NCT02722577)
NCT ID: NCT02722577
Last Updated: 2019-08-06
Results Overview
COMPLETED
20 participants
Intraoperative, an average of 2 hours
2019-08-06
Participant Flow
Presence of clinical arrhythmia during the ablation procedure is a requirement for the study protocol and can not be guaranteed at the time of enrollment. 2 of the patients who have consented did not have clinical arrhythmia present at the time of the ablation procedure and were therefore not included in the study.
Participant milestones
| Measure |
Main Group
All patients enrolled in this study
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
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 |
Main Group
n=20 Participants
All patients enrolled in this study
|
|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 16 • n=20 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
|
Region of Enrollment
China
|
20 Participants
n=20 Participants
|
|
Hypertension (%)
|
2 Participants
n=20 Participants
|
|
Diabetes mellitus (%)
|
0 Participants
n=20 Participants
|
|
Origin of arrhythmia in left ventricle outflow tract
|
4 Participants
n=20 Participants
|
|
QRS duration (ms)
|
147 ms
STANDARD_DEVIATION 16 • n=20 Participants
|
|
Height (cm)
|
165 cm
STANDARD_DEVIATION 8 • n=20 Participants
|
|
Weight (kg)
|
69 kg
STANDARD_DEVIATION 9 • n=20 Participants
|
PRIMARY outcome
Timeframe: Intraoperative, an average of 2 hoursOutcome measures
| Measure |
Main Group
n=20 Participants
All patients enrolled in this study
|
|---|---|
|
Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery
|
20 Participants
|
Adverse Events
Main Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Guodong Niu
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place