Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371846
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-10
Brief Title:
Comparative Study of the Surface Electrocardiogram Signals During the Implantation of Conduction System Pacing Devices
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Comparative Study of the Surface and Endocavitary Signals of Cardiac Pacing System Analyzers With Respect to the Conventional Polygraphy Systems Signals During Implantation of Conduction System Pacing Devices
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
Introduction and objectives Left bundle branch area pacing LBBAP is a novel modality of physiologic pacing that requires an adequate assessment of the endocardium as well as the body-surface electrocardiographic signals for a successful pacing-lead implantation The objective of the study consist of assessing if LBBAP criteria specifically septal and left bundle branch pacing LBBP criteria can be satisfactory measured using the signals resulting from different cardiac pacing analyzers PSAs by comparing them to the conventional signals obtained from multichannel polygraph systems MPSs during the implantation procedure
Methods Comparative observational prospective multicenter study between the signals obtained by PSA vs MPS of consecutive patients who underwent a LBBAP strategy as first intention
Methods Comparative observational prospective multicenter study between the signals obtained by PSA vs MPS of consecutive patients who underwent a LBBAP strategy as first intention
Detailed Description:
METHODS All participants will provide written informed consent before undergoing the procedure The study was approved by the Institutional Review Board of Hospital del Mar Barcelona and complied with the declaration of Helsinki
Study protocol and data collection This was a non-randomized prospective multicentric study From july 2023 to may 2024 consecutive patients over 18 years of age who will undergo a LBBAP system as first intention will be enrolled from five participating hospitals Baseline characteristics including demography pacing indication basal QRS and left ventricular ejection fraction will be collected For the implantation procedure analysis total procedural time total fluoroscopy time total radiation dosage pacing electrocardiogram parameters including the paced QRS morphology and duration V6 R wave peak time V6-RWPT and changes between selective and non-selective LBBP will be recorded as well as the pacing lead parameters including R-wave amplitude threshold and impedance with unipolar and bipolar configurations First 24hs complications will be all documented
In a prephase of the study a comparison between MPS and PSA surface signals was performed Medtronic and Biotronik PSAs use a four-leads monitoring system three of them detecting bipolar signals The Right Arm RA lead was placed at the back of the patient at the level of the heart to diminish the distance between leads and generating two pseudomonopolar signals together with the two other leads Left Arm LA and Left Foot LF placed at V1 and V6 standard positions modified leads position Boston Scientific BSC and Abbott PSAs use a five-leads monitoring system one of them V1 lead capable of detecting a monopolar signal In this case the V1 lead was placed at the standard V1 position and the LA lead was moved to the V6 position modified lead position The similarities on the QRS morphology compared to the MPS were confirmed in all PSAs
Implantation procedure All patients received standard medical treatment according to their clinical conditions and underwent the LBBAP implantation in accordance with the standardized pacemaker implantation technique Bipolar electrograms were filtered through a bandpass of 30-500 Hertz Hz and recorded on a MPS at a speed of 100milimetersecond mms and a gain of 01 miliVoltcentimeter mVcm Before the implantation procedure the PSA-leads will be placed as previously described Signals will be optimized and displayed in each PSA screen at a speed range between 50-100 mmsec and at gain of 005 mVmm The basal QRS morphology and duration corresponding to V1 and V6 PSA-leads will be compared to those of the MSP to assess the correct position of the electrodes In case of detecting a QRS morphology andor duration on the PSA significantly different from the MSP more than 2 deflections in opposite directions or a difference in QRS duration 10 msec repositioning of the leads wil be suggested to obtain a similar QRS morphology and duration between both recording systems The sheath as well as the pacing-lead characteristics and final position LVSP vs LBBP will be left at operators discretion
Left bundle branch LBB capture was defined in the presence of a paced QRS with right bundle branch block RBBB morphology in V1 initial r wave in lead V1 and at least one of the following criteria
1 V6-RWPT 80 msec
2 V1-V6 inter-peak interval 33 msec
3 QRS transition from non-selective left bundle branch pacing NS-LBBP to selective left bundle branch pacing S-LBBP or NS-LBBP to left ventricular septal pacing LVSP during pacing threshold
4 Sudden increase of V6-RWPT 15 msec because of reducing pacing output
5 Left bundle potential-V6RWPT stim-V6RWPT 10 msec For patients without initial r wave in V1 LBBP will be considered in the presence of QRS transition during pacing LVSP will be defined by a paced QRS showing a typical terminal R-wave in V1 anatomical position of the lead in the left ventricular septum documented by fluoroscopy and not fulfilling the additional criteria previously described for LBBP
During the implant procedure initial septal unipolar pacing will be performed looking for an W morphology in V1 in the mid-septal area and the last recommendations of international guidelines will be followed for placing the lead Briefly when the selected initial position at operators discretion is fulfilled the lead is deployed using rapid turns and lead depth within the septum is assessed using pacing QRS morphology pacing impedance unfiltered electrogram amplitude from lead tip or using contrast through the sheath The objective of the study is to validate and compare the criteria for the LBBAP in both recording systems Specifically paced QRS in V1 and V6 V6-RWPT V1-V6 inter-peak interval abrupt Δ V6-RWPT 15 msec at decremental pacing output and QRS transitions between non-selective and selective capture of the conduction system during pacing were measured and confirmed in both the PSA and the MSP to assess the final lead position Endocavitary signals from the lead tip will be evaluated and measured to detect congruent pre-ventricular signals from the conduction system as well
Monitoring and discharge Patients will be in-hospital for a period of 24 hours Before discharge all patients will undergo a 12-lead electrocardiogram an X-ray in postero-anterior and lateral views as well as clinical monitoring to rule out acute complications
Study protocol and data collection This was a non-randomized prospective multicentric study From july 2023 to may 2024 consecutive patients over 18 years of age who will undergo a LBBAP system as first intention will be enrolled from five participating hospitals Baseline characteristics including demography pacing indication basal QRS and left ventricular ejection fraction will be collected For the implantation procedure analysis total procedural time total fluoroscopy time total radiation dosage pacing electrocardiogram parameters including the paced QRS morphology and duration V6 R wave peak time V6-RWPT and changes between selective and non-selective LBBP will be recorded as well as the pacing lead parameters including R-wave amplitude threshold and impedance with unipolar and bipolar configurations First 24hs complications will be all documented
In a prephase of the study a comparison between MPS and PSA surface signals was performed Medtronic and Biotronik PSAs use a four-leads monitoring system three of them detecting bipolar signals The Right Arm RA lead was placed at the back of the patient at the level of the heart to diminish the distance between leads and generating two pseudomonopolar signals together with the two other leads Left Arm LA and Left Foot LF placed at V1 and V6 standard positions modified leads position Boston Scientific BSC and Abbott PSAs use a five-leads monitoring system one of them V1 lead capable of detecting a monopolar signal In this case the V1 lead was placed at the standard V1 position and the LA lead was moved to the V6 position modified lead position The similarities on the QRS morphology compared to the MPS were confirmed in all PSAs
Implantation procedure All patients received standard medical treatment according to their clinical conditions and underwent the LBBAP implantation in accordance with the standardized pacemaker implantation technique Bipolar electrograms were filtered through a bandpass of 30-500 Hertz Hz and recorded on a MPS at a speed of 100milimetersecond mms and a gain of 01 miliVoltcentimeter mVcm Before the implantation procedure the PSA-leads will be placed as previously described Signals will be optimized and displayed in each PSA screen at a speed range between 50-100 mmsec and at gain of 005 mVmm The basal QRS morphology and duration corresponding to V1 and V6 PSA-leads will be compared to those of the MSP to assess the correct position of the electrodes In case of detecting a QRS morphology andor duration on the PSA significantly different from the MSP more than 2 deflections in opposite directions or a difference in QRS duration 10 msec repositioning of the leads wil be suggested to obtain a similar QRS morphology and duration between both recording systems The sheath as well as the pacing-lead characteristics and final position LVSP vs LBBP will be left at operators discretion
Left bundle branch LBB capture was defined in the presence of a paced QRS with right bundle branch block RBBB morphology in V1 initial r wave in lead V1 and at least one of the following criteria
1 V6-RWPT 80 msec
2 V1-V6 inter-peak interval 33 msec
3 QRS transition from non-selective left bundle branch pacing NS-LBBP to selective left bundle branch pacing S-LBBP or NS-LBBP to left ventricular septal pacing LVSP during pacing threshold
4 Sudden increase of V6-RWPT 15 msec because of reducing pacing output
5 Left bundle potential-V6RWPT stim-V6RWPT 10 msec For patients without initial r wave in V1 LBBP will be considered in the presence of QRS transition during pacing LVSP will be defined by a paced QRS showing a typical terminal R-wave in V1 anatomical position of the lead in the left ventricular septum documented by fluoroscopy and not fulfilling the additional criteria previously described for LBBP
During the implant procedure initial septal unipolar pacing will be performed looking for an W morphology in V1 in the mid-septal area and the last recommendations of international guidelines will be followed for placing the lead Briefly when the selected initial position at operators discretion is fulfilled the lead is deployed using rapid turns and lead depth within the septum is assessed using pacing QRS morphology pacing impedance unfiltered electrogram amplitude from lead tip or using contrast through the sheath The objective of the study is to validate and compare the criteria for the LBBAP in both recording systems Specifically paced QRS in V1 and V6 V6-RWPT V1-V6 inter-peak interval abrupt Δ V6-RWPT 15 msec at decremental pacing output and QRS transitions between non-selective and selective capture of the conduction system during pacing were measured and confirmed in both the PSA and the MSP to assess the final lead position Endocavitary signals from the lead tip will be evaluated and measured to detect congruent pre-ventricular signals from the conduction system as well
Monitoring and discharge Patients will be in-hospital for a period of 24 hours Before discharge all patients will undergo a 12-lead electrocardiogram an X-ray in postero-anterior and lateral views as well as clinical monitoring to rule out acute complications
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