Trial Outcomes & Findings for Cardioneuroablation for Neurocardiogenic Syncope (NCT NCT02009982)

NCT ID: NCT02009982

Last Updated: 2016-11-04

Results Overview

The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2016-11-04

Participant Flow

Participant milestones

Measure	Cardioneuroablation Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure	Standard Medical Thearpy Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cardioneuroablation for Neurocardiogenic Syncope

Baseline characteristics by cohort

Measure	Cardioneuroablation n=1 Participants Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure	Standard Medical Thearpy n=2 Participants Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: No data was analyzed due to low enrollment.

The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Months

Population: No data was analyzed due to low enrollment.

The secondary endpoint for this study will be the incidence of serious adverse events related to the study procedure within the 12 month follow-up protocol

Outcome measures

Outcome data not reported

Adverse Events

Cardioneuroablation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Medical Thearpy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cardioneuroablation n=1 participants at risk Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure	Standard Medical Thearpy n=2 participants at risk Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
Cardiac disorders Chest Pain	100.0% 1/1 • Number of events 1 • Data for adverse events were collected for 12 months.	0.00% 0/2 • Data for adverse events were collected for 12 months.
Nervous system disorders Tremors	100.0% 1/1 • Number of events 1 • Data for adverse events were collected for 12 months.	0.00% 0/2 • Data for adverse events were collected for 12 months.
Infections and infestations Upper Respiratory Infection	100.0% 1/1 • Number of events 2 • Data for adverse events were collected for 12 months.	0.00% 0/2 • Data for adverse events were collected for 12 months.
Cardiac disorders Angina	100.0% 1/1 • Number of events 1 • Data for adverse events were collected for 12 months.	0.00% 0/2 • Data for adverse events were collected for 12 months.
Blood and lymphatic system disorders Edema	100.0% 1/1 • Number of events 1 • Data for adverse events were collected for 12 months.	0.00% 0/2 • Data for adverse events were collected for 12 months.
Skin and subcutaneous tissue disorders Shingles	0.00% 0/1 • Data for adverse events were collected for 12 months.	50.0% 1/2 • Number of events 1 • Data for adverse events were collected for 12 months.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/1 • Data for adverse events were collected for 12 months.	50.0% 1/2 • Number of events 1 • Data for adverse events were collected for 12 months.
Nervous system disorders Syncope	0.00% 0/1 • Data for adverse events were collected for 12 months.	100.0% 2/2 • Number of events 3 • Data for adverse events were collected for 12 months.

Additional Information

Dr. David De Lurgio

Emory University

Phone: 404-251-1481

Email: ddelurg@emory.edu

Results disclosure agreements

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