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Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction (SANOK)

Primary Purpose

Sinus Node Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Permament pacemaker implantation
Cardioneuroablation
Sponsored by
Stec, Sebastian, MD, PhD, FESC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinus Node Dysfunction focused on measuring cardioneuroablation, pacemaker, sinus node dysfunction, bradycardia, extracardiac vagal nerve stimulation, ECG monitoring, quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age, 18-75 years
  • Sinus node dysfunction/disease fulfilling criteria for elective pacemaker implantation according to current ESC guidelines (I, IIa, and IIb )
  • Optimization of chronic disease treatment
  • Ability to provide informed consent to participate in the study
  • Ability to understand patient information.

Exclusion Criteria:

  • Contraindications to invasive and noninvasive procedures used in the study
  • Uncontrolled endocrine and systemic disorders
  • Persistent atrial fibrillation
  • Dilated cardiomyopathy
  • Severe congenital heart valve disease or cardiomyopathy
  • Functional NYHA class III/IV
  • Left ventricular ejection fraction <35%
  • Left atrial diameter >50 mm
  • Previous catheter ablation
  • Contraindications to anticoagulant treatment
  • Contraindications to catheter ablation
  • Chronic, advanced two- or third-degree atrioventricular block associated with structural heart disease
  • Contraindications to noninvasive tests
  • Pregnancy and lactation
  • Previous cardiac surgery
  • Implanted pacemaker device
  • Neck and chest abnormalities
  • Myocardial infarction in the previous 6 months
  • Percutaneous coronary intervention in the previous 3 months
  • Estimated survival <24 months
  • Participation in another drug or medical device program
  • Limited capacity to understand the study protocol or psychological disorders precluding informed consent to participate in the study.
  • Any other uncontrolled chronic diseases, neck and chest abnormalities, or disorders that constitute a contraindication to catheter ablation, antiarrhytmic treatment, general anesthesia, or extracardiac vagal nerve stimulation (ECANS)
  • Severe obesity (body mass index ≥40 kg/m2 )

Sites / Locations

  • Center of Interventional Cardiology, Electrotherapy and Angiology G.V.M. Carint
  • Medical Center SABAMEDRecruiting
  • Subcarpatian Center for Cardiovascular Interventions, Laboratory of Electrophysiology, Cardioneuroablation, Ablation, Arrhythmia and Heart Electrostimulation, G.V.M. CarintRecruiting
  • Department of Cardiology, Laboratory of Invasive Electrophysiology, 4th Military Teaching Hospital in Wroclaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A - PACEMAKER

Group B - CARDIONEUROABLATION

Arm Description

According with ESC indications for elective pacemaker implantation due to SND will referred for PM implantation.

According with ESC indications for elective PM implantation due to SND will referred for ICM/ILR implantation or prolonged ECG monitoring. Within 4 weeks patient will be screened by interdisciplinary team and autonomic tests (including atropine tests) will be performed. Than, based on atropine tests, electrophysiologic study and extracardiac vagal nerve stimulation, final indication for cardioneuroablation will be established. Biatrial, binodal cardioneuroablation will be performed with anatomical approach with bilateral extra cardiac vagal nerve stimulation during general anesthesia. Than, patient will be closely monitored and indication for PM implantation will be verified.

Outcomes

Primary Outcome Measures

Number of Participants Who Had Freedom From Bradycardia Symptoms at 6 months
Number of participants who had freedom from bradycardia symptoms at 6 months - for all participants - who had CNA versus PM implanation versus no procedure performed. Trial - patient is randomized to standard PM implatantion (Group A) or CNA procedure (Group B). Registry (Group C) - patient refused participation in the trial, and decided to have share-decision making procedure (CNA, PM implanatation) or no intervention at all - taking into account evidence, risk-benefit assesments, expected outcomes and individual patient preferences.
Number of Participants with Pacemaker Implantation at 6 months
Number of participants with PM implantation at 6 months

Secondary Outcome Measures

Number of Events of Procedural Complications
Procedural Complications (death, stroke, myocardial infarction, heart failure, conduction abnormalities, pericardial effusion requiring drainage, hematoma, pseudoaneurysm (0-6 month changes)
Number of Participants With Post-ablation Inducibility of Sinus Arrest and/or AV Block by Vagal Nerve Stimulation
Number of participants with post-ablation inducibility of sinus arrest and/or AV block in pre- and post- procedural extracardiac Vagal Nerve stimulation
Effect of CNA on Quality of Life Parameters Based on EQ-5D-5L Questionnaire
EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on a scale of 1-5 ponts, that describes the patient's health state. The maximum score of 1 indicates the best health state, higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health, 0 indicating the worst health status.
Effect of CNA on Quality of Life Parameters Based on SF-36 Questionnaire
SF-36 questionnaire consists of 36 questions that are distributed across eight scales. Each scale is directly transformed into 0-100 scale. The lower the score the more disability, the higher the score the less disability.
Effect of CNA on Fatigue Based on Modified Fatigue Impact Scale (MFIS)
MFIS is a validated, standardized, 21-item questionnaire, which provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. Total scores range from 0-84. The lower the score the less fatigue, the higher the score the more fatigue impairs physical, cognitive, and psychosocial functioning.
Effect of CNA on Depression/Anxiety based on Modified Hospital Anxiety and Depression Scale (HADS-M)
HADS-M is a validated, standardized 16-item questionnaire to evaluate the association between anxiety and depression and the degree of illness acceptance in patients. Total scores range from 0-64. Higher scores indicate a greater degree of anxiety or depression.
Effect of CNA on Sleep Disorders Based on Epworth Sleep Scale (ESS)
The ESS score is a standardized, validated 8-item questionnaire (with scores 0-3 each). The total score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.
Effect of CNA on Sleep Disorders Based on Athens Insomnia Scale-8 (AIS-8)
AIS-8 is a standardized, validated questionnaire assessing 8 factors related to nocturnal sleep and daytime dysfunction, which are rated on a 0-3 scale. The sleep is evaluated from the cumulative score of all factors and reported as an individual's sleep outcome. Higher score indicates more sleep disturbances.

Full Information

First Posted
October 14, 2021
Last Updated
March 5, 2023
Sponsor
Stec, Sebastian, MD, PhD, FESC
Collaborators
KCRI
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1. Study Identification

Unique Protocol Identification Number
NCT05196126
Brief Title
Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
Acronym
SANOK
Official Title
Comparison of Strategies for Permanent Pacemaker Implantation and/or Cardioneuroablation in Patients With Sinus Node Dysfunction: a Noncommercial Physician-initiated Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stec, Sebastian, MD, PhD, FESC
Collaborators
KCRI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only. The study will use medical products applied for invasive and nonivasive procedures performed at the participating centers.
Detailed Description
All patients meeting the inclusion criteria and not meeting the exclusion criteria will be invited to participate in the study. The patient will receive an informed consent form describing the study protocol. After speaking to the investigator and receiving detailed answers to all questions, the patient will sign the written informed consent form to participate in the study or will choose to opt out of randomization and to be included in the registry only. Premenopausal women who will provide consent to participate in the study will undergo a pregnancy test before any invasive procedure. During the 12-month study duration, the use of effective contraception is recommended. The patient will be asked to complete the questionnaires on bradycardia symptoms and quality of life (QOL). Any patient included in the study will be randomized into group A or group B. Patients included in the registry (group C) will undergo patient-tailored interventions and treatments through shared decision-making with a possibility of permanent cardiac pacing (subgroup CA), vagal nerve stimulation (VNS) according to the protocol and cardioneuroablation (subgroup CB), as well as observation (subgroup CO).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Node Dysfunction
Keywords
cardioneuroablation, pacemaker, sinus node dysfunction, bradycardia, extracardiac vagal nerve stimulation, ECG monitoring, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A - PACEMAKER
Arm Type
Active Comparator
Arm Description
According with ESC indications for elective pacemaker implantation due to SND will referred for PM implantation.
Arm Title
Group B - CARDIONEUROABLATION
Arm Type
Experimental
Arm Description
According with ESC indications for elective PM implantation due to SND will referred for ICM/ILR implantation or prolonged ECG monitoring. Within 4 weeks patient will be screened by interdisciplinary team and autonomic tests (including atropine tests) will be performed. Than, based on atropine tests, electrophysiologic study and extracardiac vagal nerve stimulation, final indication for cardioneuroablation will be established. Biatrial, binodal cardioneuroablation will be performed with anatomical approach with bilateral extra cardiac vagal nerve stimulation during general anesthesia. Than, patient will be closely monitored and indication for PM implantation will be verified.
Intervention Type
Procedure
Intervention Name(s)
Permament pacemaker implantation
Intervention Description
PM implantation
Intervention Type
Procedure
Intervention Name(s)
Cardioneuroablation
Other Intervention Name(s)
Extracardiac vagal nerve stimulation
Intervention Description
Biatrial, binodal CNA procedure with anatomical approach will be performed with pre- and post procedural extracardiac vagal nerve stimulation in general anesthesia.
Primary Outcome Measure Information:
Title
Number of Participants Who Had Freedom From Bradycardia Symptoms at 6 months
Description
Number of participants who had freedom from bradycardia symptoms at 6 months - for all participants - who had CNA versus PM implanation versus no procedure performed. Trial - patient is randomized to standard PM implatantion (Group A) or CNA procedure (Group B). Registry (Group C) - patient refused participation in the trial, and decided to have share-decision making procedure (CNA, PM implanatation) or no intervention at all - taking into account evidence, risk-benefit assesments, expected outcomes and individual patient preferences.
Time Frame
6 months
Title
Number of Participants with Pacemaker Implantation at 6 months
Description
Number of participants with PM implantation at 6 months
Time Frame
6 monhts
Secondary Outcome Measure Information:
Title
Number of Events of Procedural Complications
Description
Procedural Complications (death, stroke, myocardial infarction, heart failure, conduction abnormalities, pericardial effusion requiring drainage, hematoma, pseudoaneurysm (0-6 month changes)
Time Frame
0-6 months
Title
Number of Participants With Post-ablation Inducibility of Sinus Arrest and/or AV Block by Vagal Nerve Stimulation
Description
Number of participants with post-ablation inducibility of sinus arrest and/or AV block in pre- and post- procedural extracardiac Vagal Nerve stimulation
Time Frame
1 day (peri-procedural)
Title
Effect of CNA on Quality of Life Parameters Based on EQ-5D-5L Questionnaire
Description
EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on a scale of 1-5 ponts, that describes the patient's health state. The maximum score of 1 indicates the best health state, higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health, 0 indicating the worst health status.
Time Frame
0, 3, 6, 9, 12 months
Title
Effect of CNA on Quality of Life Parameters Based on SF-36 Questionnaire
Description
SF-36 questionnaire consists of 36 questions that are distributed across eight scales. Each scale is directly transformed into 0-100 scale. The lower the score the more disability, the higher the score the less disability.
Time Frame
0, 3, 6, 9, 12 months
Title
Effect of CNA on Fatigue Based on Modified Fatigue Impact Scale (MFIS)
Description
MFIS is a validated, standardized, 21-item questionnaire, which provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. Total scores range from 0-84. The lower the score the less fatigue, the higher the score the more fatigue impairs physical, cognitive, and psychosocial functioning.
Time Frame
0, 6, 12 months
Title
Effect of CNA on Depression/Anxiety based on Modified Hospital Anxiety and Depression Scale (HADS-M)
Description
HADS-M is a validated, standardized 16-item questionnaire to evaluate the association between anxiety and depression and the degree of illness acceptance in patients. Total scores range from 0-64. Higher scores indicate a greater degree of anxiety or depression.
Time Frame
0, 6, 12 months
Title
Effect of CNA on Sleep Disorders Based on Epworth Sleep Scale (ESS)
Description
The ESS score is a standardized, validated 8-item questionnaire (with scores 0-3 each). The total score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.
Time Frame
0, 6, 12 months
Title
Effect of CNA on Sleep Disorders Based on Athens Insomnia Scale-8 (AIS-8)
Description
AIS-8 is a standardized, validated questionnaire assessing 8 factors related to nocturnal sleep and daytime dysfunction, which are rated on a 0-3 scale. The sleep is evaluated from the cumulative score of all factors and reported as an individual's sleep outcome. Higher score indicates more sleep disturbances.
Time Frame
0, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age, 18-75 years Sinus node dysfunction/disease fulfilling criteria for elective pacemaker implantation according to current ESC guidelines (I, IIa, and IIb ) Optimization of chronic disease treatment Ability to provide informed consent to participate in the study Ability to understand patient information. Exclusion Criteria: Contraindications to invasive and noninvasive procedures used in the study Uncontrolled endocrine and systemic disorders Persistent atrial fibrillation Dilated cardiomyopathy Severe congenital heart valve disease or cardiomyopathy Functional NYHA class III/IV Left ventricular ejection fraction <35% Left atrial diameter >50 mm Previous catheter ablation Contraindications to anticoagulant treatment Contraindications to catheter ablation Chronic, advanced two- or third-degree atrioventricular block associated with structural heart disease Contraindications to noninvasive tests Pregnancy and lactation Previous cardiac surgery Implanted pacemaker device Neck and chest abnormalities Myocardial infarction in the previous 6 months Percutaneous coronary intervention in the previous 3 months Estimated survival <24 months Participation in another drug or medical device program Limited capacity to understand the study protocol or psychological disorders precluding informed consent to participate in the study. Any other uncontrolled chronic diseases, neck and chest abnormalities, or disorders that constitute a contraindication to catheter ablation, antiarrhytmic treatment, general anesthesia, or extracardiac vagal nerve stimulation (ECANS) Severe obesity (body mass index ≥40 kg/m2 )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Stec, MD, PhD
Phone
+48600298022
Email
smstec@wp.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Edyta Stodółkiewicz-Nowarska, MD PhD
Phone
785885425
Email
edytastod@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Stec, MD, PhD
Organizational Affiliation
Medical Center SABAMED Medicans
Official's Role
Study Chair
Facility Information:
Facility Name
Center of Interventional Cardiology, Electrotherapy and Angiology G.V.M. Carint
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janusz Sledz, MD
Phone
+48 602535589
Email
januszsledz@onet.eu
First Name & Middle Initial & Last Name & Degree
Janusz Sledz, MD
Facility Name
Medical Center SABAMED
City
Rzeszów
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Reichert, MD
Phone
+48 69365129
Email
agarei@mp.pl
First Name & Middle Initial & Last Name & Degree
Agnieszka Reichert, MD
Facility Name
Subcarpatian Center for Cardiovascular Interventions, Laboratory of Electrophysiology, Cardioneuroablation, Ablation, Arrhythmia and Heart Electrostimulation, G.V.M. Carint
City
Sanok
ZIP/Postal Code
38-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoni Wileczek, MD
Phone
+48 663517874
Email
antoniwileczek@gmail.com
First Name & Middle Initial & Last Name & Degree
Sebastian Stec, MD, PhD
Facility Name
Department of Cardiology, Laboratory of Invasive Electrophysiology, 4th Military Teaching Hospital in Wroclaw
City
Wroclaw
ZIP/Postal Code
50-07
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrianna Szalonka, BA
Phone
+48 535502175
Email
ada.szalonka@interia.pl
First Name & Middle Initial & Last Name & Degree
Dariusz Jagielski, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction

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