- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04896424
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
296
Phase
- 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
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 |
Intervention / Treatment |
---|---|
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.
|
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
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
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.
Investigators
- 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)
November 1, 2015
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
May 11, 2021
First Submitted That Met QC Criteria
May 20, 2021
First Posted (Actual)
May 21, 2021
Study Record Updates
Last Update Posted (Actual)
May 24, 2021
Last Update Submitted That Met QC Criteria
May 20, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID 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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