Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation

NCT04896424 | Completed

• 1 other identifier: KB-0012/91/10/15
• Study Type: interventional
• Target: 296
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vagal Nerve Stimulation; Autonomic Nervous System; Catheter Ablation

Keywords

atrial fibrillation; cardiac autonomic nervous system; cryoballoon ablation; ganglionated plexi; heart rate variability; vagal response

Outcome Measures

Primary Outcomes (5)

• The number of patients free from atrial fibrillation following a cryoballoon-based pulmonary veins isolation beyond a 3-month blanking period.

  Outpatient visit was scheduled at 3 months following ablation. A detailed medical history was taken with emphasis on registered atrial fibrillation episodes or atrial fibrillation suggestive symptoms. 24 hour Holter monitoring was performed in all patients.

  3 months

• The number of patients free from atrial fibrillation following a cryoballoon-based pulmonary veins isolation beyond a 3-month blanking period.

  Outpatient visit was scheduled at 6 months following ablation. A detailed medical history was taken with emphasis on registered atrial fibrillation episodes or atrial fibrillation suggestive symptoms. 24 hour Holter monitoring was performed in all patients.

  6 months

• The number of patients free from atrial fibrillation following a cryoballoon-based pulmonary veins isolation beyond a 3-month blanking period.

  Outpatient visit was scheduled at 12 months following ablation. A detailed medical history was taken with emphasis on registered atrial fibrillation episodes or atrial fibrillation suggestive symptoms. 24 hour Holter monitoring was performed in all patients.

  12 months

• The number of patients free from atrial fibrillation following a cryoballoon-based pulmonary veins isolation beyond a 3-month blanking period.

  Outpatient visit was scheduled at 18 months following ablation. A detailed medical history was taken with emphasis on registered atrial fibrillation episodes or atrial fibrillation suggestive symptoms. 24 hour Holter monitoring was performed in all patients.

  18 months

• The number of patients free from atrial fibrillation following a cryoballoon-based pulmonary veins isolation beyond a 3-month blanking period.

  Outpatient visit was scheduled at 24 months following ablation. A detailed medical history was taken with emphasis on registered atrial fibrillation episodes or atrial fibrillation suggestive symptoms. 24 hour Holter monitoring was performed in all patients.

  24 months

Other Outcomes (4)

• The incidence of vagal response observed during cryoballoon-based pulmonary veins isolation

  At the time of procedure

• The impact on of vagal response on intrinsic cardiac autonomic nervous system with widely accepted heart rate variability (HRV) analysis

  3 months

• The impact on of vagal response on intrinsic cardiac autonomic nervous system with widely accepted heart rate variability (HRV) analysis

  6 months

Study Arms (1)

Cryoballoon-based pulmonary veins isolation cohort

OTHER

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.

Procedure: cryoballoon-based pulmonary veins isolation

Interventions

cryoballoon-based pulmonary veins isolation 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).

Cryoballoon-based pulmonary veins isolation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of paroxysmal atrial fibrillation

You may not qualify if:

• Previous atrial fibrillation ablation

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Radoslaw M Kiedrowicz, PhD

  Pomeranian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 21, 2021
• Study Start: November 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2019
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share