Trial Outcomes & Findings for Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia (NCT NCT00979303)

NCT ID: NCT00979303

Last Updated: 2018-03-08

Results Overview

Total fluoroscopy time in minutes

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 74 participants
• Primary outcome timeframe: During the Ablation procedure
• Results posted on: 2018-03-08

Participant Flow

Participant milestones

Measure	Control Group Control Patients - Undergo ablation procedures with radiation/fluoroscopy only	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.
Overall Study STARTED	37	37
Overall Study COMPLETED	37	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia

Baseline characteristics by cohort

Measure	Control Group n=37 Participants Control Patients - Undergo ablation procedures with radiation/fluoroscopy only	Study Group n=37 Participants 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.	Total n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.2 years n=5 Participants	14.7 years n=7 Participants	14.5 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	37 participants n=7 Participants	74 participants n=5 Participants
Weight	57.9 kg n=5 Participants	59.1 kg n=7 Participants	58.5 kg n=5 Participants
Height	162 cm n=5 Participants	162.2 cm n=7 Participants	162.1 cm n=5 Participants
Chest circumference	17.4 cm n=5 Participants	17.5 cm n=7 Participants	17.4 cm n=5 Participants
BSA	1.6 m^2 n=5 Participants	1.6 m^2 n=7 Participants	1.6 m^2 n=5 Participants
BMI	21.4 kg/m^2 n=5 Participants	22.3 kg/m^2 n=7 Participants	21.9 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: During the Ablation procedure

Total fluoroscopy time in minutes

Outcome measures

Measure	Control Group n=37 Participants Control Patients - Undergo ablation procedures with radiation/fluoroscopy only	Study Group n=37 Participants 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.
Total Fluoroscopy Time	18.3 minutes Interval 5.4 to 74.4	7.5 minutes Interval 0.0 to 52.9

SECONDARY outcome

Timeframe: During Ablation Procedure

Total radiation exposure measured in mGy

Outcome measures

Measure	Control Group n=37 Participants Control Patients - Undergo ablation procedures with radiation/fluoroscopy only	Study Group n=37 Participants 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.
Total Radiation Exposure	387 mGy Interval 68.0 to 2701.0	110 mGy Interval 0.0 to 3026.0

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Study Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control Group n=37 participants at risk Control Patients - Undergo ablation procedures with radiation/fluoroscopy only	Study Group n=37 participants at risk 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.
Skin and subcutaneous tissue disorders Hematoma	13.5% 5/37 • Number of events 5 • 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.	8.1% 3/37 • Number of events 3 • 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.
Respiratory, thoracic and mediastinal disorders bronchospasm	0.00% 0/37 • 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.	2.7% 1/37 • Number of events 1 • 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.
Nervous system disorders Headache	2.7% 1/37 • Number of events 1 • 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.	2.7% 1/37 • Number of events 1 • 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.
Nervous system disorders Vasovagal syncope	0.00% 0/37 • 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.	2.7% 1/37 • Number of events 1 • 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.
Nervous system disorders Neuropathy	0.00% 0/37 • 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.	2.7% 1/37 • Number of events 1 • 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.
Cardiac disorders Mechanical trauma to pathway	0.00% 0/37 • 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.	2.7% 1/37 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Groin Pain	2.7% 1/37 • Number of events 1 • 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.	0.00% 0/37 • 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.
Skin and subcutaneous tissue disorders Skin abrasion	2.7% 1/37 • Number of events 1 • 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.	0.00% 0/37 • 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.

Additional Information

Christina Miyake

Children's Hospital Boston

Phone: 832-826-5650

Email: cymiyake@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place