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Sinus Node DysfunctionDINERVAPACENCT05186220

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

A study testing Cardioneuroablation and Permanent dual chamber pacemaker implantation in people with Sinus Node Dysfunction and Sick Sinus Syndrome, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Sinus Node Dysfunction, Sick Sinus Syndrome
What is being tested?
Cardioneuroablation and Permanent dual chamber pacemaker implantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
1 Nov 2021to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Carlos Minguito Carazo, MD contact

981 95 07 93

carlosminguito@hotmail.es

Spain1 site, 1 recruiting

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

    Carlos Carazo, MD, carlosminguito@hotmail.es

    Carlos Minguito Carazo, MD

    Recruiting

Other trials in Spain

About this study

Official title: Endocardial Ablation of Ganglionated Plexi Versus Pacemaker Implantation in Patients With Symptomatic Sinus Node Dysfunction

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.

Read the 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.

Being tested
Cardioneuroablation, Permanent dual chamber pacemaker implantation
Keywords
cardioneuroablation
Medical subject headings
Sick Sinus Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CardioneuroablationProcedure or surgery

    Also called Endocardial ganglion plexus ablation

    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.

  • Permanent dual chamber pacemaker implantationDevice

    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.

Study groups in NCT05186220
Study groupRoleWhat they receive
CardioneuroablationExperimentalAfter 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.
Receives: Procedure: Cardioneuroablation
Permanent pacemaker implantationActive comparatorA dual chamber pacemaker implantation will be performed. The device will be programmed in a AAI-DDDR mode to avoid unnecessary ventricular pacing.
Receives: Device: Permanent dual chamber pacemaker implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 6 months

Secondary outcomes (4)

  1. 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

    Measured: Baseline and 6 months

  2. 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.

    Measured: Baseline and 6 months

  3. 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.

    Measured: Baseline and 6 months

  4. Differences in 6 month free survival from syncope between both groups

    Syncope will be defined as any spontaneous loss of conscious with posterior recovery.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start1 Nov 2021
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion1 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05186220
Sponsor's protocol ID
2021/307
Acronym
DINERVAPACE
Status last verified
Jan 2022
First submitted
16 Dec 2021
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol, statistical analysis plan and informed consent form will be available for any who requires.

Publications

  • 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.

    PubMed 33198486

  • 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.

    PubMed 31330187

  • 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.

    PubMed 21712276

Questions about this trial

What is this clinical trial studying?

A study testing Cardioneuroablation and Permanent dual chamber pacemaker implantation in people with Sinus Node Dysfunction and Sick Sinus Syndrome, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carlos Minguito Carazo, MD (981 95 07 93, carlosminguito@hotmail.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the SF-36 Health Survey of quality of life (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05186220, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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