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Completed

NCT Number: NCT04896424

Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation

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.

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Key information

Conditions

Vagal Nerve Stimulation Arrhythmias, Cardiac Atrial Fibrillation Autonomic Nervous System Cardiovascular Diseases Catheter Ablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of paroxysmal atrial fibrillation

Exclusion criteria

  • Previous atrial fibrillation ablation

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 3 months

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 12 months

    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.

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

    Time frame: 18 months

    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.

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

    Time frame: 24 months

    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.

Other outcomes

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

    Time frame: At the time of procedure

    Vagal reaction was defined as sinus bradycardia <40 bpm, sinus arrest, atrioventricular block or hypotension registered anytime from the beginning of cryoapplication up to 1 minute following balloon deflation preceded by a thawing period.

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

    Time frame: 3 months

    A 24h holter ECG was acquired on the day before ablation and 3 months thereafter. Holter electrocardiograms were recorded by a DMS 300-3A (DM Software Inc., USA). A HRV was analysed by a Cardioscan II system (DM Software). Artifacts, premature complexes, and atrial runs were excluded from calculation. Records with abnormal beats, rhythms and noise that constituted >5% of all beats were repeated. HRV parameters included mean heart rate (mHR), five time-domain variables:(1) SDNN, (2) SDNN index, (3) SDANN, (4) rMSSD, (5) pNN50, and three frequency domain variables: (1) LF, (2) HF, and (3) LF/HF ratio

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

    Time frame: 6 months

    A 24h holter ECG was acquired on the day before ablation and 6 months thereafter. Holter electrocardiograms were recorded by a DMS 300-3A (DM Software Inc., USA). A HRV was analysed by a Cardioscan II system (DM Software). Artifacts, premature complexes, and atrial runs were excluded from calculation. Records with abnormal beats, rhythms and noise that constituted >5% of all beats were repeated. HRV parameters included mean heart rate (mHR), five time-domain variables:(1) SDNN, (2) SDNN index, (3) SDANN, (4) rMSSD, (5) pNN50, and three frequency domain variables: (1) LF, (2) HF, and (3) LF/HF ratio

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

    Time frame: 12 months

    A 24h holter ECG was acquired on the day before ablation and 12 months thereafter. Holter electrocardiograms were recorded by a DMS 300-3A (DM Software Inc., USA). A HRV was analysed by a Cardioscan II system (DM Software). Artifacts, premature complexes, and atrial runs were excluded from calculation. Records with abnormal beats, rhythms and noise that constituted >5% of all beats were repeated. HRV parameters included mean heart rate (mHR), five time-domain variables:(1) SDNN, (2) SDNN index, (3) SDANN, (4) rMSSD, (5) pNN50, and three frequency domain variables: (1) LF, (2) HF, and (3) LF/HF ratio

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

Does Vagal Response Indicate Cardiac Autonomic Modulation and Improve the Therapeutic Effect of Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation? Insides From Cryoballoon Ablation

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
May 21, 2021
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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