Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774262
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-02-17
Brief Title:
Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block
Sponsor:
American Heart of Poland
Organization:
American Heart of Poland
Study Overview
Official Title:
TELE-monitoring for Standard Pacemaker Implantation or Delayed Pacemaker Implantation After AutonomicElectrophysiologic Evaluation and Cardioneuroablation for managEment of Functional atrioventriculaR Block - Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELE-SPACER
Brief Summary:
The TELE-SPACER study is a multicenter noncommercial physician-initiated proof-of-concept prospective randomized controlled unblinded clinical trial and registry designed to compare two methods of treatment of patients with functional Atrio-Ventricular Block AVB the guidelines-recommended elective pacemaker PM therapy vs cardiovascular autonomic tests CAT electrophysiologic assessment EPS with referral to cardioneuroablation CNA and reevaluation of indications for PM therapy
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
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
Detailed Description:
TELE-SPACER trial will enroll a minimum of 100 participants males and females 18-75 years old 1 with indications for elective PM implantation due to atrioventricular block AVB according to 2021 ESC guidelines on cardiac pacing 2 who had positive atropine tests Participants will be randomized into two groups - either optimized guideline-recommended PM therapy group A n50 or reevaluation for PM therapy after CATEPS and experimental procedure CNA group B n50 Participants who will choose to opt-out of randomization will be included in the registry group C and will undergo patient-tailored intervention through shared decision-making with a possibility of either PM implantation CNA or observation only The registry is expected to include up to 200 participants
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 11 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 monitoringCATEPS 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 HBPLBBAP - 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 247 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 andor 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
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 11 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 monitoringCATEPS 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 HBPLBBAP - 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 247 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None