Ventricular Outflow Tract Tachycardia
Conditions
Brief summary
Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).
Detailed description
The proposed study aims to evaluate the predictive value of using reversed polarity in adjacent bipolar EGMs (bi-RP method) and unipolar EGM with QS morphology (uni-QS method) for identifying successful ablation site, and evaluate the feasibility of enhancing uni-QS method's performance by using its morphology characteristics such as descending slope and symmetry.
Interventions
PROCEDURERadio-frequency Ablation
A procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo ablation for idiopathic OTVA * Have the ability to provide informed consent for study participation.
Exclusion criteria
* Be currently participating in any other investigational study * Be less than 18 years of age * Be pregnant * Has any other conditions that are not suitable for catheter ablation (including but are not limited to active whole-body infection or sepsis, coagulation or hemorrhage disorder history)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery | Intraoperative, an average of 2 hours |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Main Group All patients enrolled in this study | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Main Group | — |
|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 16 | — |
| Diabetes mellitus (%) | 0 Participants | — |
| Height (cm) | 165 cm STANDARD_DEVIATION 8 | — |
| Hypertension (%) | 2 Participants | — |
| Origin of arrhythmia in left ventricle outflow tract | 4 Participants | — |
| QRS duration (ms) | 147 ms STANDARD_DEVIATION 16 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment China | 20 Participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
| Weight (kg) | 69 kg STANDARD_DEVIATION 9 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery
Time frame: Intraoperative, an average of 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Group | Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery | 20 Participants |