Supraventricular Tachycardia
Conditions
Keywords
Pediatric, Electrophysiology, Ablation, Radiation, Devices, SVT
Brief summary
The purpose of this study is to determine whether the additional use of non-fluoroscopic imaging modalities can decrease the use of radiation exposure during standard ablation procedures for supraventricular tachycardia (SVT) in children.
Detailed description
The standard of care for children undergoing SVT ablation is radiation (fluoroscopy) to see the heart. Non fluoroscopic imaging tools have been utilized for adult atrial fibrillation procedures. These tools utilize magnetic fields to visualize the heart without using radiation. The purpose of this study was to determine if these 3D mapping tools could reduce radiation exposure during SVT ablation procedures could be performed using these 3D tools.
Interventions
DEVICEIntracardiac echocardiography and 3D navigational system
Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intent to treat use of non fluoroscopic mapping system with traditional fluoroscopic mapping system during elective catheter ablation in children 8-17 with normal cardiac anatomy
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Age \>/=8 * Weight \>/=25kg * Structurally normal heart (no major cardiac defects) * History of SVT * No prior history of cardiac surgery or ablation
Exclusion criteria
* Congenital Heart Disease * Prior history of cardiac surgery or ablation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Fluoroscopy Time | During the Ablation procedure | Total fluoroscopy time in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Radiation Exposure | During Ablation Procedure | Total radiation exposure measured in mGy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Control Patients - Undergo ablation procedures with radiation/fluoroscopy only | 37 |
| Study Group Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.
Intracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure. | 37 |
| Total | 74 |
Baseline characteristics
| Characteristic | Control Group | Study Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 37 Participants | 35 Participants | 72 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 14.2 years | 14.7 years | 14.5 years |
| BMI | 21.4 kg/m^2 | 22.3 kg/m^2 | 21.9 kg/m^2 |
| BSA | 1.6 m^2 | 1.6 m^2 | 1.6 m^2 |
| Chest circumference | 17.4 cm | 17.5 cm | 17.4 cm |
| Height | 162 cm | 162.2 cm | 162.1 cm |
| Region of Enrollment United States | 37 participants | 37 participants | 74 participants |
| Sex: Female, Male Female | 20 Participants | 18 Participants | 38 Participants |
| Sex: Female, Male Male | 17 Participants | 19 Participants | 36 Participants |
| Weight | 57.9 kg | 59.1 kg | 58.5 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 8 / 37 | 6 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
Total Fluoroscopy Time
Total fluoroscopy time in minutes
Time frame: During the Ablation procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Total Fluoroscopy Time | 18.3 minutes |
| Study Group | Total Fluoroscopy Time | 7.5 minutes |
Secondary
Total Radiation Exposure
Total radiation exposure measured in mGy
Time frame: During Ablation Procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Total Radiation Exposure | 387 mGy |
| Study Group | Total Radiation Exposure | 110 mGy |