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Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radio-frequency Ablation | Procedure | A procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery | Intraoperative, an average of 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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20 patients meeting the inclusion and exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Guodong Niu, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Group | All patients enrolled in this study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Group | All patients enrolled in this study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery | Posted | Count of Participants | Participants | Intraoperative, an average of 2 hours |
|
|
Intraoperative, an average of 2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Group | All patients enrolled in this study | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 | +86(10)88398866 | guodongniu@fuwai.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2016 | Jul 26, 2019 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hypertension (%) | Hypertension is measured in units of millimeters of mercury (mmHg). A subject is determined to have hypertension when the systolic blood pressure is higher than 130 mmHg or the diastolic blood pressure is higher than 80mmHg. | Count of Participants | Participants |
|
| Diabetes mellitus (%) | The diabetes mellitus condition is determined when the subject's Glycated hemoglobin level is 6.5 percent or higher on two separate tests. | Count of Participants | Participants |
|
| Origin of arrhythmia in left ventricle outflow tract | Determined when the subject's origin of arrhythmia was in left ventricle outflow tract during the electrocardiography testing. | Count of Participants | Participants |
|
| QRS duration (ms) | Mean | Standard Deviation | ms |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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