Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation

NCT ID: NCT04896424

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2019-12-31

Brief 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.

Detailed Description

An interplay between left atrial (LA) ganglionated plexi (GP), a part of the intrinsic cardiac autonomic nervous system (CANS), and pulmonary veins (PVs) is considered to be an important mechanism related with the initiation and maintenance of atrial fibrillation (AF). Therefore additional GP ablation has been reported with better ablation outcomes when added to RF-based PV isolation (PVI). A cryoballoon ablation (CBA) is an anatomically based approach which allows PVI that is highly safe and efficacious. The extension of the scar created by the cryoballoon frequently extends beyond the PV orifice in the acute and chronic post-ablation phase creating a set of lesions that are near the LA-GP area and inadvertent damage. A marked vagal response (VR) observed during CBA is considered a marker for the CANS modification. However, changes in the autonomic tone were independently noted from the presence of VR in several studies. Moreover, it is not clear if these changes are transient or long-lasting, and it has been shown that the presence of VR increases ablation success although with conflicting results. In previous studies assessing the influence of CBA on the autonomic balance, CANS modulation was appraised with different surrogates, a small number of individuals were usually recruited and both paroxysmal and persistent AF populations were included. Therefore, the investigators sought to evaluate the incidence of VR observed during CBA-based PVI, its impact on CANS assessed with widely accepted heart rate variability (HRV) analysis, and in relation to ablation outcomes in a large paroxysmal AF (PAF) cohort.

Conditions

Vagal Nerve Stimulation; Autonomic Nervous System; Catheter Ablation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoballoon-based pulmonary veins isolation cohort

Patients treated with a 28-mm second-generation cryoballoon (Arctic Front Advance, Medtronic) for paroxysmal atrial fibrillation and screened over a 2-year post-ablation period.

Group Type: OTHER

cryoballoon-based pulmonary veins isolation

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of paroxysmal atrial fibrillation

Exclusion Criteria

• Previous atrial fibrillation ablation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pomeranian Medical University Szczecin

OTHER

Sponsor Role: lead

Responsible Party

Radoslaw Kiedrowicz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Radoslaw M Kiedrowicz, PhD

Role: PRINCIPAL_INVESTIGATOR

Pomeranian Medical University

Other Identifiers

KB-0012/91/10/15

Identifier Type: -

Identifier Source: org_study_id