Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation

NACompletedINTERVENTIONAL
Enrollment

296

Participants

Timeline

Start Date

November 1, 2015

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2019

Conditions
Vagal Nerve StimulationAutonomic Nervous SystemCatheter Ablation
Interventions
PROCEDURE

cryoballoon-based pulmonary veins isolation

A cryoballoon is introduced to the LA via a steerable sheath following a single transseptal puncture. The balloon is advanced toward the PV ostium and inflated. PV occlusion is documented by the injection of contrast. Optimal vessel occlusion is assumed when the PV showes complete contrast retention without any backflow to the atrium. The freezing time is chosen between 180 and 240s and left at the operator's discretion, along with a decision if to follow with a bonus-freeze cycle. The application is aborted and the cryoballoon is repositioned in the case of ineffective cooling or when the nadir temperature decreases \< -60°C, to avoid excessive cooling. In cases where a real-time recording of PV potentials is available a short time-to-isolation\<60s resultes in a single 180s freeze cycle. CBA always startes from the left upper PV (LUPV) followed by the left lower PV (LLPV).

All Listed Sponsors
lead

Pomeranian Medical University Szczecin

OTHER

NCT04896424 - Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation | Biotech Hunter | Biotech Hunter