Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Control Patients - Undergo ablation procedures with radiation/fluoroscopy only | |
| Study Group | Experimental | Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracardiac echocardiography and 3D navigational system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fluoroscopy Time | Total fluoroscopy time in minutes | During the Ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total Radiation Exposure | Total radiation exposure measured in mGy | During Ablation Procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christina Y. Miyake, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21167315 | Result | Miyake CY, Mah DY, Atallah J, Oikle HP, Melgar ML, Alexander ME, Berul CI, Cecchin F, Walsh EP, Triedman JK. Nonfluoroscopic imaging systems reduce radiation exposure in children undergoing ablation of supraventricular tachycardia. Heart Rhythm. 2011 Apr;8(4):519-25. doi: 10.1016/j.hrthm.2010.12.022. Epub 2010 Dec 15. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| Archived consent, protocol and analytic plan. | View IPD |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Control Patients - Undergo ablation procedures with radiation/fluoroscopy only |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Control Patients - Undergo ablation procedures with radiation/fluoroscopy only |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Total Fluoroscopy Time | Total fluoroscopy time in minutes | Posted | Median | Full Range | minutes | During the Ablation procedure |
|
1 year
Adverse events were evaluated in all patients during the study, prior to discharge and in follow up at 1 month and 1 year after the procedure.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Control Patients - Undergo ablation procedures with radiation/fluoroscopy only |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment | Groin hematoma |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Miyake | Children's Hospital Boston | 832-826-5650 | cymiyake@bcm.edu |
Not provided
| ID | Term |
|---|---|
| D013617 | Tachycardia, Supraventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
|
Study completed prior to change in common rule. Requests should be directed to the investigation team at Boston Children's Hospital through mark.alexander@cardio.chboston.org |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Full Range | kg |
|
| Height | Mean | Full Range | cm |
|
| Chest circumference | Mean | Full Range | cm |
|
| BSA | Mean | Full Range | m^2 |
|
| BMI | Mean | Full Range | kg/m^2 |
|
|
|
| Secondary | Total Radiation Exposure | Total radiation exposure measured in mGy | Posted | Median | Full Range | mGy | During Ablation Procedure |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 8 |
| 37 |
| EG001 | 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. | 0 | 37 | 0 | 37 | 6 | 37 |
| bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Brochospasm after adenosine |
|
| Headache | Nervous system disorders | Systematic Assessment | Headache |
|
| Vasovagal syncope | Nervous system disorders | Systematic Assessment | Vasovagal syncope |
|
| Neuropathy | Nervous system disorders | Systematic Assessment | Neuropathy |
|
| Mechanical trauma to pathway | Cardiac disorders | Systematic Assessment | Trauma to pathway |
|
| Groin Pain | Skin and subcutaneous tissue disorders | Systematic Assessment | Groin pain 1 week after discharge |
|
| Skin abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin abrasion |
|
Not provided
Not provided
Not provided
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |