Sick Sinus Syndrome Clinical Trial
— DINERVAPACEOfficial 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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinico Universitario de Santiago | Santiago de Compostela | A Coruña |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinico Universitario de Santiago | Hospital Universitario Lucus Augusti, Spanish Society of Cardiology |
Spain,
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. — View 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/ — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline and 6 months | |
Secondary | 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 | Baseline and 6 months | |
Secondary | 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. | Baseline and 6 months | |
Secondary | 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. | Baseline and 6 months | |
Secondary | Differences in 6 month free survival from syncope between both groups | Syncope will be defined as any spontaneous loss of conscious with posterior recovery. | Baseline and 6 months |
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