MedTrace Logo

Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation

NCT04896424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2021-05-24

No results posted yet for this study

Summary

The investigators sought to evaluate the incidence and influence of vagal response observed during cryoballoon-based pulmonary vein isolation on the cardiac autonomic nervous system (CANS) and ablation outcomes in paroxysmal atrial fibrillation cohort. 296 patients were treated with a 28-mm second-generation cryoballoon (Arctic Front Advance, Medtronic). Preprocedural pulmonary veins anatomy and their ostial dimensions were acquired with a computed tomography. 74 patients without structural heart disease and with no concomitant diseases were chosen for a detailed CANS assessment with heart rate variability analysis. All patients were screened over a 2-year post-ablation period.

Conditions

  • Vagal Nerve Stimulation
  • Autonomic Nervous System
  • Catheter 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).

Sponsors & Collaborators

  • Pomeranian Medical University Szczecin

    lead OTHER

Principal Investigators

  • Radoslaw M Kiedrowicz, PhD · Pomeranian Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2017-12-31
Completion
2019-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04896424 on ClinicalTrials.gov