Second Study on Cardio-neuromodulation in Humans

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 10, 2016

Primary Completion Date

April 1, 2020

Study Completion Date

May 11, 2020

Conditions
Cardiac DiseaseSyncopeSyncope, VasovagalSick Sinus Syndrome
Interventions
DEVICE

radio-frequency ablation

"Patients will undergo a tailored 'radio-frequency ablation' of the ARGP with the Smart Touch™ catheter or with the nMARQ™ catheter. Radiofrequency applications will be interrupted if no significant P-P interval shortening is observed after 30 seconds or if P-P interval is ≤ 550 ms during ablation.~The ablation procedure is considered complete when one of the following conditions is fulfilled:~P-P interval \< 70% baseline procedural P-P interval after 5minute of waiting time; P-P interval \< 600 ms after 5 minute of waiting time; 5 radiofrequency applications \> 30 seconds have been delivered with the nMARQ™ catheter or 10 applications with the Smart Touch catheter."

Trial Locations (1)

2820

Imeldaziekenhuis, Bonheiden

All Listed Sponsors
lead

Imelda Hospital, Bonheiden

OTHER

NCT02954666 - Second Study on Cardio-neuromodulation in Humans | Biotech Hunter | Biotech Hunter