Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block
NCT ID: NCT05774262
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
300 participants
INTERVENTIONAL
2023-09-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main questions TELE-SPACER aims to answer are:
* Can the investigators successfully treat functional AVB without implantable device (PM)?
* Can the investigators prove the feasibility and safety and demonstrate non-inferiority of CNA procedure in patients with functional AVB, avoiding long-term permanent pacing, its limitations, complications and costs ?
The TELE-SPACER trial will validate the European Society of Cardiology (ESC) recommendations (level C of evidence: expert opinion) for elective PM implantation and will introduce CNA as effective treatment in the functional AVB patient population.
Functional AVB - defined as a persistent or paroxysmal AVB with a positive results of atropine test
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.
NCT05896592
Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
NCT05214365
A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.
NCT02247817
Central Haemodynamics and Pacing for AV Block
NCT07276490
Proton Radiosurgery for the Treatment of Malignant Ventricular Tachyarrhythmias
NCT06769451
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patient enrollment time is anticipated to last 2 years. Recruitment will take place in four study sites, in two distinct phases. First, the investigators will identify potential participants with AVB and a positive atropine test, confirming significant dependence of heart rhythm and conduction on the vagus nerve (hyperactivity of vagus nerve). Their medical records will be analyzed by the Scientific Committee (symptoms evaluation, physical examination, documentation of AVB). In the second phase eligible participants will be invited by the investigator to participate in the trial during medical consultation. After explanations describing the study protocol, including the risk and benefits, they will sign the written informed consent to participate in the study or will choose to opt-out of randomization to be included in the registry only (group C). Informed consent will be obtained only if it is clear that the patient truly understands the nature of the study. Alternatively, the patient will be encouraged to take a copy of the consent form home to contemplate enrolment in the study. Only participants who voluntarily consent will be included. Participants will be able to withdraw at any time without compromising their medical care.
Paricipants will be randomized in 1:1 allocation to either group A or group B. Randomization will be performed centrally and assigned automatically to each patient via internet. The randomization list will be blocked per center, with randomly varying block sizes of 2 and 4. The centers will not be aware of the block sizes. The PM implantation and treatment allocation will not be blinded to the patient or follow-up physician. Participants in either arm of the study will be followed-up at regular intervals for a minimum of 12 months. During the 12-month study duration, the use of effective contraception will be recommended for women of child-bearing age.
The period of the screening and randomization visit will last from 0 to 7 days, and the qualification for elective PM implantation (group A) or elective loop recorder monitoring/CAT/EPS (group B) and subsequent therapeutic decisions (CNA, DDDR, other treatment based on the test result) from 0 to 4 weeks. Parameter analysis baseline, including ECG telemonitoring, QOL and symptoms, will take place at randomization (0 months), 3, 6 and 12 months. Participants will be assessed using cardiovascular autonomic testing (CAT) with telemedical registration at 6 and 12 months. All measured parameters, as well as demographic and clinical data will be recorded in the study database.
Participants in group A (PM, n = 50) will receive care on the basis of the 2021 ESC Guidelines on Cardiac Pacing Recommendations. They will be implanted with PM (DDD pacemaker or its modification as HBP/LBBAP - His-Purkinje or left bundle branch area pacing) and will be monitored with external ECG recorder (certified medical devices of at least class IIa) with telemonitoring. Group B participants (CNA, n = 50) will be implanted with implantable loop recorder (ILR) device (Biotronik, Biomonitor 3m), also with remote tele-monitoring, with the same thresholds for automatic episode recording. As part of telemonitoring system, all participants will receive in the period before the procedure a dedicated telemonitoring kit consisting of a portable ECG device and a tablet with a sim card for network connection. This telemonitoring kit will enable regular self-testing, symptom reporting and interactive, objective telemedicine consultations. Participants will be provided with 24/7 contact with medical staff in the telemonitoring center specialized in cardiac arrhythmias and implantable device monitoring. The major reason for ECG recording is to provide ECG documentation of clinical AVB, as well as monitoring of participants before and after CNA (or PM implantation, if accepted). In case of severe AVB, the emergency system will always be called.
Participants in group B will be referred for EPS and ECVS (extracardiac vagal nerve stimulation) with the possibility of simultaneous CNA after exclusion of advanced and occult distal AVBs. Once the effectiveness of the CNA is confirmed, the patient will be further monitored. If CNA is not succesful and/or its immediate effectiveness is not confirmed (meeting the ESC criteria for pacemaker implantation after CNA), the patient will be referred for pacemaker implantation and will cross-over into group A.
CNA will be performed in group B under general anesthesia by experienced operators (at least 25 CNA procedures preformed). After EPS, a biatral, binodal, anatomically guided CNA will be performed under ECVS guidance, with a demonstration of the vagal reflex (complete asystole or AVB with atrial pacing) at the onset of the CNA and its complete disappearance after a successful CNA. Additional ablation substrates will also be allowed and performed.
Participants included in the registry (group C) will undergo an individually tailored intervention through shared decision making (SDM) with the option of implantation of PM (subgroup CA), CNA (subgroup CB) or observation only (subgroup C0).
All participants participating in the study and registry will be asked to complete questionnaires on health-related quality of life (EQ-5D-5L, SF-36), symptoms of bradycardia (VAS), fatigue (MFIS), depression (HADS-M) and sleep (ESS, AIS-8) at 0, 6, 12 months.
The safety of the interventions will be assessed on a monthly basis (telemedicine and standard follow-up visits), with monitoring of major adverse cardiovascular events (MACE). All events will be resolved by the Central Investigation Safety Committee, which does not include members of the Investigation Steering Committee.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A - PACEMAKER
Group A, n=50 patients aged 18-75 years with indications for elective PM implantation according to the 2021 ESC guidelines for cardiac pacing due to paroxysmal or persistent AVB with a positive results of atropine test.
Group A is early elective pacemaker implantation (PM) strategy in functional AVB.
Pacemaker implantation
Elective pacemaker implantation (DDDR) for functional AVB according to the 2021 ESC Guidelines for Cardiac Pacing
Group B - CARDIONEUROABLATION
Group B, n=50 patients aged 18-75 years with indications for elective PM implantation according to the 2021 ESC guidelines for cardiac pacing due to paroxysmal or persistent AVB with a positive results of atropine test.
Group B will undergo strategy of postponed/deferred PM implantation in functional AVB. Patients wil be implanted and monitored with ILR (in case of severe symptomatic AVB always the emergency system will be called). After cardiovascular autonomic testing (CAT), electrophysiological study (EPS), extra cardiac vagal nerve stimulation (ECVS) and cardioneuroablation will be performed. If CNA is succesful, pacemaker implantation will be cancelled. If CNA is unsuccessful, second session of CNA will be planned. In case of inefficient second attempt, patients will be referred for PM implantation. They will cross-over to PACEMAKER arm.
Cardioneuroablation (CNA)
Experimental method; elective implantable loop recorder (ILR) and biatrial, binodal, atomically and electroanatomically guided CNA with extracardiac vagal nerve stimulation (ECVS) prior and after procedure monitoring (disappearance of ECVS-induced AVB with the goal of achieving post-procedure and maintaining a target heart rate \> 50 beats per minute). CNA procedure is performed with radio-frequency generators and irrigated catheters and with support of 3D-electroanatomic mapping system.
CNA group will receive external ECG recorders. The major reason for external ECG recorders is to provide documentation of clinical AVB, as well as monitoring of patients before and after CNA (or PM implantation, if accepted). In case of severe AVB symptoms always the emergency system will be called.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pacemaker implantation
Elective pacemaker implantation (DDDR) for functional AVB according to the 2021 ESC Guidelines for Cardiac Pacing
Cardioneuroablation (CNA)
Experimental method; elective implantable loop recorder (ILR) and biatrial, binodal, atomically and electroanatomically guided CNA with extracardiac vagal nerve stimulation (ECVS) prior and after procedure monitoring (disappearance of ECVS-induced AVB with the goal of achieving post-procedure and maintaining a target heart rate \> 50 beats per minute). CNA procedure is performed with radio-frequency generators and irrigated catheters and with support of 3D-electroanatomic mapping system.
CNA group will receive external ECG recorders. The major reason for external ECG recorders is to provide documentation of clinical AVB, as well as monitoring of patients before and after CNA (or PM implantation, if accepted). In case of severe AVB symptoms always the emergency system will be called.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age 18-75
3. Indication (at least one) of the European Society of Cardiology (ESC) for elective pacemaker implantation due to isolated (without sinus node dysfunction and bundle branch block) paroxysmal, persistent or reflex atrioventricular block:
1. Symptomatic first degree AVB (above 300 msec). Class IIaC
2. Symptomatic Mobitz type I second degree AVB. Class IIaC
3. AVB 2:1, even asymptomatic, but not during sleep. Class IIaC
4. Mobitz II type advanced 2nd degree AVB or complete block (3rd degree AVB). Class IC
5. Advanced AVB during AF regardless of symptoms, but not during sleep. Class IC
6. Reflex syncope in patients over 40 years of age with documented pauses within the AVB mechanism, symptomatic (\>3 sec) or asymptomatic \>6 sec. Class IC
7. Reflex syncope in patients over 40 years of age with documented pauses within AVB mechanism in the course of sick sinus syndrome (CSS). Class IC
8. Reflex syncope in patients over 40 years of age with documented pauses within AVB mechanism during tilt test. Class IC
Exclusion Criteria
2. Sinus node dysfunction with indication for pacemaker implantation
3. Planned ablation of the atrioventricular junction
4. Severe prolonged bradycardia in advanced AVB requiring intravenous drugs and temporary pacing
5. Status post cardiac surgery
6. Acute myocardial infarction and heart failure (not related to bradycardia)
7. Status post percutaneous valvular intervention or ablation
8. Acute infection or any other accompanying disease which is contraindication to percutaneous procedures and/or implantation of a pacemaker
9. Pregnancy, nursing or planned pregnancy within 12 months
10. Decompensated chronic diseases (endocrine disorders, electrolyte disorders, etc.)
11. Advanced cardiomyopathies with indication for ICD implantation in primary or secondary prevention of sudden cardiac death (SCD)
12. Advanced ventricular arrhythmias with indication for ICD implantation in primary or secondary prevention of SCD
13. Persistent right or left bundle branch block
14. Musculoskeletal diseases with separate indications for pacemaker implantation
15. Contraindications to the procedures used in the study
16. The presence of a mental illness or limitation of cognitive functions that prevent independent participation in the study, including the use of telemedicine services
17. Any abnormality found that is considered by the Principal Investigator a contraindication to participate in the stidy due to data interpretation or safety issue
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
American Heart of Poland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sebastian Stec
Clinical Professor, Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sebastian M Stec, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
American Heart of Poland
Edyta Stodolkiewicz-Nowarska, MD, PhD
Role: STUDY_DIRECTOR
American Heart of Poland
Krzysztof Milewski, MD, PhD
Role: STUDY_CHAIR
American Heart of Poland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
American Heart of Poland
Dąbrowa Górnicza, , Poland
American Heart of Poland
Mielec, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.
Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
Shen WK, Sheldon RS, Benditt DG, Cohen MI, Forman DE, Goldberger ZD, Grubb BP, Hamdan MH, Krahn AD, Link MS, Olshansky B, Raj SR, Sandhu RK, Sorajja D, Sun BC, Yancy CW. 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2017 Aug 1;136(5):e60-e122. doi: 10.1161/CIR.0000000000000499. Epub 2017 Mar 9. No abstract available.
Klank-Szafran M, Stec S, Sledz J, Janion M. [Radiofrequency ablation and cardioneuroablation for AVNRT and atrioventricular block]. Kardiol Pol. 2010 Jun;68(6):720-4. Polish.
Aksu T, Guler TE, Bozyel S, Ozcan KS, Yalin K, Mutluer FO. Cardioneuroablation in the treatment of neurally mediated reflex syncope: a review of the current literature. Turk Kardiyol Dern Ars. 2017 Dec;45(1):33-41. doi: 10.5543/tkda.2016.55250.
Baysal E, Guler TE, Gopinathannair R, Bozyel S, Yalin K, Aksu T. Catheter Ablation of Atrioventricular Block: From Diagnosis to Selection of Proper Treatment. JACC Case Rep. 2020 Sep 15;2(11):1793-1801. doi: 10.1016/j.jaccas.2020.07.050. eCollection 2020 Sep.
Aksu T, Gopinathannair R, Bozyel S, Yalin K, Gupta D. Cardioneuroablation for Treatment of Atrioventricular Block. Circ Arrhythm Electrophysiol. 2021 Sep;14(9):e010018. doi: 10.1161/CIRCEP.121.010018. Epub 2021 Sep 1.
Wileczek A, Polewczyk A, Kluk M, Kutarski A, Stec S. Ultrasound-guided imaging for vagus nerve stimulation to facilitate cardioneuroablation for the treatment of functional advanced atrioventricular block. Indian Pacing Electrophysiol J. 2021 Nov-Dec;21(6):403-406. doi: 10.1016/j.ipej.2021.06.008. Epub 2021 Jun 26.
Josiak K, Stec S, Zysko D, Skonieczny B, Kosior J, Sledz J, Wilczek A, Stodolkiewicz-Nowarska E, Biel B, Szymkiewicz P, Skoczynski P, Karbarz D, Ludwik B, Banasiak W, Jagielski D. Safety and efficacy of His bundle pacing validated by extracardiac vagal nerve stimulation (HIS-STORY). Cardiol J. 2022;29(4):698-701. doi: 10.5603/CJ.a2022.0053. Epub 2022 Jun 15. No abstract available.
Reichert A, Wileczek A, Stec S. Cardioneuroablation for the effective treatment of recurrent vasovagal syncope to restore driving abilities. Kardiol Pol. 2022;80(11):1158-1160. doi: 10.33963/KP.a2022.0189. Epub 2022 Aug 10. No abstract available.
Gajda R, Knechtle B, Gebska-Kuczerowska A, Gajda J, Stec S, Krych M, Kwasniewska M, Drygas W. Amateur Athlete with Sinus Arrest and Severe Bradycardia Diagnosed through a Heart Rate Monitor: A Six-Year Observation-The Necessity of Shared Decision-Making in Heart Rhythm Therapy Management. Int J Environ Res Public Health. 2022 Aug 19;19(16):10367. doi: 10.3390/ijerph191610367.
Pachon JC, Pachon EI, Pachon JC, Lobo TJ, Pachon MZ, Vargas RN, Jatene AD. "Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. Europace. 2005 Jan;7(1):1-13. doi: 10.1016/j.eupc.2004.10.003.
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.
Pachon M JC, Pachon M EI, Santillana P TG, Lobo TJ, Pachon CTC, Pachon M JC, Albornoz V RN, Zerpa A JC. Simplified Method for Vagal Effect Evaluation in Cardiac Ablation and Electrophysiological Procedures. JACC Clin Electrophysiol. 2015 Oct;1(5):451-460. doi: 10.1016/j.jacep.2015.06.008. Epub 2015 Aug 21.
Yao Y, Shi R, Wong T, Zheng L, Chen W, Yang L, Huang W, Bao J, Zhang S. Endocardial autonomic denervation of the left atrium to treat vasovagal syncope: an early experience in humans. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):279-86. doi: 10.1161/CIRCEP.111.966465. Epub 2012 Jan 24.
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.
Sun W, Zheng L, Qiao Y, Shi R, Hou B, Wu L, Guo J, Zhang S, Yao Y. Catheter Ablation as a Treatment for Vasovagal Syncope: Long-Term Outcome of Endocardial Autonomic Modification of the Left Atrium. J Am Heart Assoc. 2016 Jul 8;5(7):e003471. doi: 10.1161/JAHA.116.003471.
Aksu T, Golcuk E, Yalin K, Guler TE, Erden I. Simplified Cardioneuroablation in the Treatment of Reflex Syncope, Functional AV Block, and Sinus Node Dysfunction. Pacing Clin Electrophysiol. 2016 Jan;39(1):42-53. doi: 10.1111/pace.12756. Epub 2015 Oct 26.
Osorio TG, Paparella G, Stec S, Chierchia GB, de Asmundis C. Cardiac parasympathetic modulation in the setting of radiofrequency ablation for atrial fibrillation. Arch Med Sci. 2019 Apr 26;17(6):1716-1721. doi: 10.5114/aoms.2019.84717. eCollection 2021.
Piotrowski R, Baran J, Kulakowski P. Cardioneuroablation using an anatomical approach: a new and promising method for the treatment of cardioinhibitory neurocardiogenic syncope. Kardiol Pol. 2018;76(12):1736-1738. doi: 10.5603/KP.a2018.0200. Epub 2018 Oct 19. No abstract available.
Pachon-M EI, Pachon-Mateos JC, Higuti C, Santillana-P TG, Lobo T, Pachon C, Pachon-Mateos J, Zerpa J, Ortencio F, Amarante RC, Silva RF, Osorio TG. Relation of Fractionated Atrial Potentials With the Vagal Innervation Evaluated by Extracardiac Vagal Stimulation During Cardioneuroablation. Circ Arrhythm Electrophysiol. 2020 Apr;13(4):e007900. doi: 10.1161/CIRCEP.119.007900. Epub 2020 Mar 19.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022/ABM/03/00035
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.