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Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction (DINERVAPACE)

Primary Purpose

Sinus Node Dysfunction, Sick Sinus Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cardioneuroablation
Permanent dual chamber pacemaker implantation
Sponsored by
Hospital Clinico Universitario de Santiago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinus Node Dysfunction focused on measuring cardioneuroablation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic sinus node dysfunction (dizziness, asthenia or syncope) clearly related to an abnormal electrocardiogram finding (sinus arrest, sinoatrial block, extreme bradycardia (<40 bpm) or chronotropic incompetence in the exercise test).
  • Absence of structural cardiopathy

Exclusion Criteria:

  • Left ventricular ejection fraction <50%
  • Severe valvular disease
  • Any type of cardiomyopathy such as hypertrophic cardiomyopathy
  • Previous ischemic heart disease
  • QRS interval >130 ms
  • Atrioventricular conduction disorder with a former indication of pacemaker implantation (atrioventricular block Mobitz II, advanced atrioventricular block, complete atrioventricular block)
  • Lifetime expectance <12 months

Sites / Locations

  • Hospital Clinico Universitario de SantiagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cardioneuroablation

Permanent pacemaker implantation

Arm Description

After 3D mapping of the surface of the left and right atrium and the superior vena cava (Ensite Navx or Carto system), localization of ganglion plexus (GP) will be performed either anatomically and/or by means of high frequency stimulation (HFS). The anterior and superior right sided GP will always be ablated per protocol. Other GP will be ablated according to interventional electrophysiologist judgement. The endpoint of the ablation procedure will be 1) absence of a vagal response after HFS from the right jugular vein and 2) an increase in at least 10 bpm as compared to baseline.

A dual chamber pacemaker implantation will be performed. The device will be programmed in a AAI-DDDR mode to avoid unnecessary ventricular pacing.

Outcomes

Primary Outcome Measures

Change from baseline in the SF-36 Health Survey of quality of life
The SF-36 Health Survey is a validated, well known generic test for assessment of the health-related quality of life of patients.

Secondary Outcome Measures

6 month free survival from permanent pacemaker implantation in the interventional group (cardioneuroablation)
Percentage of patients free from pacemaker at one year in the cardioneuroablation group
Change in maximal heart rate and chronotropic incompetence in the exercise test
All patients will perform a baseline exercise test and after 6 months. Maximal heart rate and chronotropic response will be recorded.
Differences in complications rates between both gropus
Most common complications regarding the procedure. In the cardioneuroablation group; complications regarding vascular access and pericardial tamponade. In the pacemaker group, pneumothorax, device infection and vascular access.
Differences in 6 month free survival from syncope between both groups
Syncope will be defined as any spontaneous loss of conscious with posterior recovery.

Full Information

First Posted
December 16, 2021
Last Updated
January 6, 2022
Sponsor
Hospital Clinico Universitario de Santiago
Collaborators
Spanish Society of Cardiology, Hospital Universitario Lucus Augusti
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1. Study Identification

Unique Protocol Identification Number
NCT05186220
Brief Title
Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction
Acronym
DINERVAPACE
Official Title
Endocardial Ablation of Ganglionated Plexi Versus Pacemaker Implantation in Patients With Symptomatic Sinus Node Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinico Universitario de Santiago
Collaborators
Spanish Society of Cardiology, Hospital Universitario Lucus Augusti

4. Oversight

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

5. Study Description

Brief Summary
Endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (VV), functional atrioventricular block (AVB) and sinus node dysfunction (SND) with a component of vagal hypertonia. Nevertheless, there is currently a paucity of literature about the results according to the type of presentation (VV, AVB or SND). The investigators aim to assess the safety and efficacy of cardioneuroablation for the treatment of symptomatic SND.
Detailed Description
Sinus node dysfunction (SND), also known as sick sinus syndrome, comprises a wide spectrum of sinoatrial dysfunctions, ranging from sinus bradycardia, sinoatrial block, and sinus arrest to bradycardia tachycardia syndrome. An additional manifestation of SND is an inadequate chronotropic response to exercise, reported as chronotropic incompetence. Since the first cardiac denervation was reported in 2005, several registries and retrospective studies using this therapeutic approach for reflex syncope, SND and functional atrioventricular block have been published. However, due to the lack of randomized studies, current guidelines recommend permanent pacemaker implantation for patients with symptomatic SND in order to improve symptoms. Therefore, the purpose of the present study is to assess the safety and efficacy of cardioneuroablation versus permanent pacemaker implantation for the treatment of symptomatic SND. This is a multicenter, randomized, open, interventional study. After being informed of the study and potential risks, participants will undergo a one week screening period to determine eligibility for the study entry. During this week, participants will undergo an exercise test, atropine test, and a 24 hour-holter electrocardiogram. Then, participants who meet the eligibility criteria, will be randomized 1:1 to receive permanent pacemaker implantation (control group) or cardioneuroablation (interventional group). The primary endpoint (improve in quality of life assessed with 36-Item Short Form Survey (SF-36)) will be evaluated at six months since randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Node Dysfunction, Sick Sinus Syndrome
Keywords
cardioneuroablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardioneuroablation
Arm Type
Experimental
Arm Description
After 3D mapping of the surface of the left and right atrium and the superior vena cava (Ensite Navx or Carto system), localization of ganglion plexus (GP) will be performed either anatomically and/or by means of high frequency stimulation (HFS). The anterior and superior right sided GP will always be ablated per protocol. Other GP will be ablated according to interventional electrophysiologist judgement. The endpoint of the ablation procedure will be 1) absence of a vagal response after HFS from the right jugular vein and 2) an increase in at least 10 bpm as compared to baseline.
Arm Title
Permanent pacemaker implantation
Arm Type
Active Comparator
Arm Description
A dual chamber pacemaker implantation will be performed. The device will be programmed in a AAI-DDDR mode to avoid unnecessary ventricular pacing.
Intervention Type
Procedure
Intervention Name(s)
Cardioneuroablation
Other Intervention Name(s)
Endocardial ganglion plexus ablation
Intervention Description
After 3D mapping of the surface of the left and right atrium and the superior vena cava (Ensite Navx, Carto), localization of ganglion plexus (GP) will be performed either anatomically and/or by means of high frequency stimulation (HFS). The anterior and superior right sided GP will always be ablated per protocol. Other GP will be ablated according to interventional electrophysiologist judgement. The endpoint of the ablation procedure will be 1) absence of a vagal response after HFS from the right jugular vein and 2) an increase in at least 10 bpm as compared to baseline.
Intervention Type
Device
Intervention Name(s)
Permanent dual chamber pacemaker implantation
Intervention Description
Under local anesthesia and using a subclavian or cephalic vein approach a dual chamber pacemaker implantation with a lead in the right atrium and a lead in the right ventricle will be performed. The device will be programmed in a AAI-DDDR mode to avoid unnecessary ventricular pacing.
Primary Outcome Measure Information:
Title
Change from baseline in the SF-36 Health Survey of quality of life
Description
The SF-36 Health Survey is a validated, well known generic test for assessment of the health-related quality of life of patients.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
6 month free survival from permanent pacemaker implantation in the interventional group (cardioneuroablation)
Description
Percentage of patients free from pacemaker at one year in the cardioneuroablation group
Time Frame
Baseline and 6 months
Title
Change in maximal heart rate and chronotropic incompetence in the exercise test
Description
All patients will perform a baseline exercise test and after 6 months. Maximal heart rate and chronotropic response will be recorded.
Time Frame
Baseline and 6 months
Title
Differences in complications rates between both gropus
Description
Most common complications regarding the procedure. In the cardioneuroablation group; complications regarding vascular access and pericardial tamponade. In the pacemaker group, pneumothorax, device infection and vascular access.
Time Frame
Baseline and 6 months
Title
Differences in 6 month free survival from syncope between both groups
Description
Syncope will be defined as any spontaneous loss of conscious with posterior recovery.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic sinus node dysfunction (dizziness, asthenia or syncope) clearly related to an abnormal electrocardiogram finding (sinus arrest, sinoatrial block, extreme bradycardia (<40 bpm) or chronotropic incompetence in the exercise test). Absence of structural cardiopathy Exclusion Criteria: Left ventricular ejection fraction <50% Severe valvular disease Any type of cardiomyopathy such as hypertrophic cardiomyopathy Previous ischemic heart disease QRS interval >130 ms Atrioventricular conduction disorder with a former indication of pacemaker implantation (atrioventricular block Mobitz II, advanced atrioventricular block, complete atrioventricular block) Lifetime expectance <12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Minguito Carazo, MD
Phone
981 95 07 93
Email
carlosminguito@hotmail.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Minguito Carazo, MD
Organizational Affiliation
Hospital Clinico Universitario de Santiago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moises Rodríguez Mañero, PhD
Organizational Affiliation
Hospital Clinico Universitario de Santiago
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jose Ramón González Juanatey, PhD
Organizational Affiliation
Hospital Clinico Universitario de Santiago
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Carazo, MD
Email
carlosminguito@hotmail.es
First Name & Middle Initial & Last Name & Degree
Carlos Minguito Carazo, MD
First Name & Middle Initial & Last Name & Degree
Moisés Rodríguez Mañero, PhD
First Name & Middle Initial & Last Name & Degree
Jose Luis Martínez Sande, PhD
First Name & Middle Initial & Last Name & Degree
Javier García Seara, PhD
First Name & Middle Initial & Last Name & Degree
Xesus Alberte Fernández López, MD
First Name & Middle Initial & Last Name & Degree
Laila González Melchor, MD
First Name & Middle Initial & Last Name & Degree
Teba González Ferrero, MD
First Name & Middle Initial & Last Name & Degree
Jose Ramón González Juanatey, PhD
First Name & Middle Initial & Last Name & Degree
Juliana Elices Teja, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol, statistical analysis plan and informed consent form will be available for any who requires.
IPD Sharing Time Frame
Baseline to 2 years
Citations:
PubMed Identifier
33198486
Citation
Pachon-M JC, Pachon-M EI, Pachon CTC, Santillana-P TG, Lobo TJ, Pachon-M JC, Zerpa-A JC, Cunha-P MZ, Higuti C, Ortencio FA, Amarante RC, Silva RF, Osorio TG. Long-Term Evaluation of the Vagal Denervation by Cardioneuroablation Using Holter and Heart Rate Variability. Circ Arrhythm Electrophysiol. 2020 Dec;13(12):e008703. doi: 10.1161/CIRCEP.120.008703. Epub 2020 Nov 16.
Results Reference
background
PubMed Identifier
31330187
Citation
Hu F, Zheng L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Right anterior ganglionated plexus: The primary target of cardioneuroablation? Heart Rhythm. 2019 Oct;16(10):1545-1551. doi: 10.1016/j.hrthm.2019.07.018. Epub 2019 Jul 19.
Results Reference
background
PubMed Identifier
21712276
Citation
Pachon JC, Pachon EI, Cunha Pachon MZ, Lobo TJ, Pachon JC, Santillana TG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011 Sep;13(9):1231-42. doi: 10.1093/europace/eur163. Epub 2011 Jun 28.
Results Reference
result

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Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction

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