An interventional study of Intracardiac echocardiography and 3D navigational system in Supraventricular Tachycardia, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 8 Years to 21 Years. Per ClinicalTrials.gov, last updated 2018-03-08.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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.
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.
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's enrollment of 74 is above the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Control Patients - Undergo ablation procedures with radiation/fluoroscopy only
Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.
Device: 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.
Also known as: AcuNav Intracardiac Echocardiography, NavX 3D navigational system, CARTO 3D navigational system
Total Fluoroscopy Time
Total fluoroscopy time in minutes
Time frame: During the Ablation procedure
Total Radiation Exposure
Total radiation exposure measured in mGy
Time frame: During Ablation Procedure
| Milestone | Control Group | Study Group |
|---|---|---|
| Started | 37 | 37 |
| Completed | 37 | 37 |
| Not completed | 0 | 0 |
Total fluoroscopy time in minutes
| minutes | Control Group | Study Group |
|---|---|---|
| Total Fluoroscopy Time | 18.3 (5.4 to 74.4) | 7.5 (0 to 52.9) |
Total radiation exposure measured in mGy
| mGy | Control Group | Study Group |
|---|---|---|
| Total Radiation Exposure | 387 (68 to 2701) | 110 (0 to 3026) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/37 (0%) | 0/37 (0%) | 8/37 (21.6%) |
| Study Group | 0/37 (0%) | 0/37 (0%) | 6/37 (16.2%) |
| Event | Control Group | Study Group |
|---|---|---|
| HematomaSkin and subcutaneous tissue disorders | 5/37 | 3/37 |
| bronchospasmRespiratory, thoracic and mediastinal disorders | 0/37 | 1/37 |
| HeadacheNervous system disorders | 1/37 | 1/37 |
| Vasovagal syncopeNervous system disorders | 0/37 | 1/37 |
| NeuropathyNervous system disorders | 0/37 | 1/37 |
| Mechanical trauma to pathwayCardiac disorders | 0/37 | 1/37 |
| Groin PainSkin and subcutaneous tissue disorders | 1/37 | 0/37 |
| Skin abrasionSkin and subcutaneous tissue disorders | 1/37 | 0/37 |
| Age, Categorical(Participants) | Control Group | Study Group | Total |
|---|---|---|---|
| <=18 years | 37 | 35 | 72 |
| Between 18 and 65 years | 0 | 2 | 2 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control Group | Study Group | Total |
|---|---|---|---|
| Mean | 14.2 (8.0 to 20.5) | 14.7 (8.6 to 22.3) | 14.5 (8.0 to 22.3) |
| Sex: Female, Male(Participants) | Control Group | Study Group | Total |
|---|---|---|---|
| Female | 20 | 18 | 38 |
| Male | 17 | 19 | 36 |
| Region of Enrollment(participants) | Control Group | Study Group | Total |
|---|---|---|---|
| United States | 37 | 37 | 74 |
| Weight(kg) | Control Group | Study Group | Total |
|---|---|---|---|
| Mean | 57.9 (27.4 to 92.2) | 59.1 (26.8 to 104.0) | 58.5 (26.8 to 104.0) |
| Height(cm) | Control Group | Study Group | Total |
|---|---|---|---|
| Mean | 162 (126 to 190) | 162.2 (134 to 184) | 162.1 (126 to 190) |
| Chest circumference(cm) | Control Group | Study Group | Total |
|---|---|---|---|
| Mean | 17.4 (12.5 to 24.5) | 17.5 (12 to 27) | 17.4 (12 to 27) |
| BSA(m^2) | Control Group | Study Group | Total |
|---|---|---|---|
| Mean | 1.6 (1.0 to 2.2) | 1.6 (1.0 to 2.2) | 1.6 (1.0 to 2.2) |
1 further baseline measures are reported on the registry.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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