Cardioneuroablation Versus Pacemaker Implantation for the Treatment of

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05186220
Study type	Interventional
Source	Hospital Clinico Universitario de Santiago
Contact	Carlos Minguito Carazo, MD
Phone	981 95 07 93
Email	carlosminguito@hotmail.es
Status	Recruiting
Phase	N/A
Start date	November 1, 2021
Completion date	November 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00286858` - Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Active, not recruiting	`NCT00228241` - Left Ventricular Function and Remodelling During Permanent Pacing	N/A
Completed	`NCT00180557` - Austria Study - Analysis of Difference Between Active and Passive Fixation Leads	Phase 4
Not yet recruiting	`NCT04149886` - Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome	N/A
Completed	`NCT01609738` - Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum	Phase 1/Phase 2
Completed	`NCT00785564` - Imaging Cardiac Electrical Remodeling With Electrocardiogram Imaging (ECGI)
Recruiting	`NCT00161551` - Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)	Phase 4
Recruiting	`NCT00224341` - Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation	Phase 4
Recruiting	`NCT05575557` - Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment	N/A
Completed	`NCT03843242` - Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker	N/A
Terminated	`NCT00475124` - Virtual Clinic Pacemaker Follow-up	Phase 4
Recruiting	`NCT06288633` - Cardioneuroablation for Bradyarrhythmia	N/A
Terminated	`NCT00236158` - The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome	Phase 2/Phase 3
Completed	`NCT00000561` - Mode Selection Trial in Sinus Node Dysfunction (MOST)	Phase 3
Completed	`NCT02154750` - AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals	N/A
Completed	`NCT02198781` - Right Ventricle (RV) Markers of Future Pacing Induced Ventricular Dysfunction - Pilot
Recruiting	`NCT01477138` - RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome	N/A
Terminated	`NCT01074749` - Optimal Sensing in Atrial Tachyarrhythmia's Study	N/A
Completed	`NCT00161538` - Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation	Phase 4
Completed	`NCT00627328` - The Atrial High Rate Episodes in Pacemaker Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms