Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation

May 20, 2021 updated by: Radoslaw Kiedrowicz, Pomeranian Medical University Szczecin

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
296

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of paroxysmal atrial fibrillation

Exclusion Criteria:

  • Previous atrial fibrillation ablation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
6 months
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.
12 months
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.
18 months
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.
24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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 months
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
6 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pomeranian Medical University Szczecin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Radoslaw M Kiedrowicz, PhD, Pomeranian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KB-0012/91/10/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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