Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488989
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-25
Brief Title:
Left Bundle Branch Area Pacing in Patients With Heart Failure
Sponsor:
National Research Center for Cardiac Surgery Kazakhstan
Organization:
National Research Center for Cardiac Surgery Kazakhstan
Study Overview
Official Title:
Left Bundle Branch Area Pacing in Patients With Heart Failure
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
LBBAPHF
Brief Summary:
The relevance of Left Bundle Branch Pacing LBBP lies in its potential as a promising treatment option for patients with heart failure and left bundle branch block LBBP aims to restore the normal physiological activation of the heart by delivering electrical impulses to the anatomical area of the left bundle branch which may lead to more effective and synchronized ventricular contractions Compared to traditional cardiac resynchronization therapy CRT this can result in a more physiological correction of dyssynchrony improvement in left ventricular pump function reduction in left ventricular volumes and a decrease in mitral regurgitation A crucial criterion is the reduction of heart failure symptoms and the enhancement of the patients quality of life
Detailed Description:
The aim The aim of Left Bundle Branch Pacing LBBP research is to assess its effectiveness in improving the contractile capacity of the left ventricular myocardium The objectives are as follows
To determine the optimal patient selection criteria
To assess long-term outcomes
To investigate safety and complications
To compare selective Left Bundle Branch Pacing LBBP with traditional cardiac resynchronization therapy in patients with heart failure
Materials and Methods
Materials The study will include patients who were hospitalized at the National Research Cardiac Surgery Center NRCS in Astana Kazakhstan The study will be a mixed-methods approach consisting of a retrospective component and a prospective component The retrospective part of the study will involve the analysis of clinical and functional data of patients with left bundle branch block and heart failure The prospective part of the study will involve the evaluation of quantitative and qualitative parameters based on transthoracic echocardiography data the functional status of patients after LBBP implantation and the assessment of long-term outcomes of the study including its impact on mortality hospitalization rates and overall prognosis
Inclusion Criteria
patients with complete left bundle branch block QRS duration greater than 150 ms left ventricular ejection fraction LVEF less than 35 and New York Heart Association NYHA functional class 2-3 who have been ineffective on optimal medical therapy for at least 3 months
patients aged 18 years or older
Signed informed consent and willingness to collaborate with the researchers
Exclusion Criteria
- patient refusal to participate in the study
Control Group
patients post-implantation of traditional CRT-D
Methods
Electrocardiography ECG
Transthoracic echocardiography EchoCG
6-minute walk test
NT-proBNP measurement
Questionnaire-based assessments SF-36 EQ-5D-5L
Scientific Novelty
This method is distinguished by its ability to provide highly physiological synchronized myocardial stimulation by stimulating the anatomical area of the left bundle branch offering advantages such as shortening the ventricular electrical systole
Advantages of the Method
Shortens ventricular electrical systole
Expands the possibilities of cardiac pacing in heart failure patients including those who cannot undergo traditional cardiac resynchronization therapy CRT due to anatomical constraints vascular anatomy or other factors
LBBP can be considered as an alternative resynchronization method for non-responders to traditional CRT
Practical Significance
The procedure is simpler less technically complex electrode fixation is easier the procedure duration and fluoroscopy time are shorter it has the ability to maintain and improve left ventricular synchrony and a shorter learning curve Inclusion Criteria
1 Male or female 18 years of age at Visit 1
2 patients with complete left bundle branch block QRS duration greater than 130 ms left ventricular ejection fraction LVEF less than 35 and New York Heart Association NYHA functional class 2-3 who have been ineffective on optimal medical therapy for at least 3 months
3 Written informed consent and assent when applicable obtained from subject or subjects legal representative and ability for subject to comply with the requirements of the study
Exclusion Criteria
1 Pregnancy
2 Psychic disturbances
3 Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data - life expectancy less than 1 year
Anticipated amount of patients - 50 STUDY TREATMENTS AND INTERVENTIONS day 1 - admission to cardiology department acquisition of medical history physical examination blood tests ECG transthoracic echoCG
day 2 - additional examinations if necessary depend on comorbidity preparing for interventional procedure
day 3 - implantation of cardiac resynchronization therapy device using Left bundle branch area pacing LBBAP
Procedure description
LBBAP procedure was performed as previously described by Huang in 2017 and Ponnusamy in 2022 Monitoring of 12-lead ECG and intracardiac electrograms were performed utilizing WorkMate Claris electrophysiology system Abbott Plymouth MN DF-1 Implantable cardioverter-defibrillator ICD lead was placed into the right ventricle RV apex in all patients LBBAP was performed using two types of leads and delivery catheters C315HIS sheath with 3830 SelectSecure lead Medtronic Minneapolis MN and Selectra 3D with Solia S60 lead Biotronik Berlin Germany Left conduction system capture was confirmed in appliance with European Heart Rhythm Association EHRA clinical consensus statement on conduction system pacing implantation 10 Main criteria to accept LBB area capture were presence of terminal R-wave in lead V1 transition in QRS morphology from non-selective to selective during threshold test short and stable V6 R-wave peak time V6RWPT80 ms in different pacing outputs V6-V1 interpeak33 ms sudden increase in V1 R-wave peak time V1RWPT10 ms split of EGM during threshold test
day 4 - chest X-ray device pocket ultrasound device interrogation with lead testing ECG
day 5 - discharge from the hospital
A Schedule of Events representing the required testing procedures to be performed for the duration of the study is diagrammed in Appendix 1
Prior to conducting any study-related activities written informed consent must be signed and dated by the subject or subjects legal representative If appropriate assent must also be obtained prior to conducting any study-related activities
EVALUATIONS BY VISIT Visit 1 admission to the hospital
1 Review the study with the subject subjects legal representative and obtain written informed consent
2 Assign the subject a unique screening number
3 Record demographics data
4 Record medical history including a history of congestive heart failure diagnosis date and prior treatments
5 Record concomitant medications
6 Perform a complete physical examination
7 Perform and record vital signs
8 Perform and record oximetry
9 Perform and record results of blood pressure testing
10 Collect blood for clinical laboratory tests chemistry hematology prothrombin time NTPROBNP
11 Obtain an echocardiogram ECG
12 Obtain a chest x-ray
13 Implantation of device
14 Chest X-ray ECG and device telemetry at 1 day after procedure
15 Discharge from the hospital and schedule subject for Visit 2 in 3 months Visit 2 3 months after discharge
1 Record any Adverse Experiences andor Review subject diary for adverse experiences 2 Perform abbreviated physical examination 3 Perform and record vital signs 4 Obtain an echocardiogram ECG chest X-ray 5 NTproBNP test 6 minute walk test 6MWT 7 Questionnaire-based assessments SF-36 EQ-5D-5L 8 Device telemetry Visit 3 6 months after discharge
1 Record any Adverse Experiences andor Review subject diary for adverse experiences
2 Perform abbreviated physical examination
3 Perform and record vital signs
4 Obtain an echocardiogram ECG chest X-ray
5 NTproBNP test
6 6MWT
7 Questionnaire-based assessments SF-36 EQ-5D-5L
8 Device telemetry Visit 4 12 months after discharge
1 Record any Adverse Experiences andor Review subject diary for adverse experiences 2 Perform abbreviated physical examination 3 Perform and record vital signs 4 Obtain an echocardiogram ECG chest X-ray 5 NTproBNP test 6 6MWT 7 Questionnaire-based assessments SF-36 EQ-5D-5L 8 Device telemetry
STATISTICAL METHODS AND CONSIDERATIONS This will be a non-randomized prospective single-centre observational study Participant characteristics and sequencing results will be summarized with descriptive statistics including medians averages and standard deviations for continuous data For categorical data proportions with a 95 confidence interval will be calculated by the Klopper-Pearson method Demographic clinical and pathological characteristics will be compared using the criterion χ2 categorical variables and t-testanalysis of variance continuous variablesValues of p005 will be considered significant
DATA COLLECTION RETENTION AND MONITORING Data Collection Instruments The Investigator will prepare and maintain adequate and accurate source documents designed to record all observations and other pertinent data for each subject treated with the study drug
Study personnel will enter data from source documents corresponding to a subjects visit into the protocol-specific electronic Case Report Form eCRF and paper CRF when the information corresponding to that visit is available Subjects will not be identified by name in the study database but will be identified by a site number subject number and initials
For eCRFs If a correction is required for an eCRF the time and date stamps track the person entering or updating eCRF data and creates an electronic audit trail For paper CRFs If a correction is made on a CRF the study staff member will line through the incorrect data write in the correct data and initial and date the change
The Investigator is responsible for all information collected on subjects enrolled in this study All data collected during the course of this study must be reviewed and verified for completeness and accuracy by the Investigator A copy of the CRF will remain at the Investigators site at the completion of the study
To determine the optimal patient selection criteria
To assess long-term outcomes
To investigate safety and complications
To compare selective Left Bundle Branch Pacing LBBP with traditional cardiac resynchronization therapy in patients with heart failure
Materials and Methods
Materials The study will include patients who were hospitalized at the National Research Cardiac Surgery Center NRCS in Astana Kazakhstan The study will be a mixed-methods approach consisting of a retrospective component and a prospective component The retrospective part of the study will involve the analysis of clinical and functional data of patients with left bundle branch block and heart failure The prospective part of the study will involve the evaluation of quantitative and qualitative parameters based on transthoracic echocardiography data the functional status of patients after LBBP implantation and the assessment of long-term outcomes of the study including its impact on mortality hospitalization rates and overall prognosis
Inclusion Criteria
patients with complete left bundle branch block QRS duration greater than 150 ms left ventricular ejection fraction LVEF less than 35 and New York Heart Association NYHA functional class 2-3 who have been ineffective on optimal medical therapy for at least 3 months
patients aged 18 years or older
Signed informed consent and willingness to collaborate with the researchers
Exclusion Criteria
- patient refusal to participate in the study
Control Group
patients post-implantation of traditional CRT-D
Methods
Electrocardiography ECG
Transthoracic echocardiography EchoCG
6-minute walk test
NT-proBNP measurement
Questionnaire-based assessments SF-36 EQ-5D-5L
Scientific Novelty
This method is distinguished by its ability to provide highly physiological synchronized myocardial stimulation by stimulating the anatomical area of the left bundle branch offering advantages such as shortening the ventricular electrical systole
Advantages of the Method
Shortens ventricular electrical systole
Expands the possibilities of cardiac pacing in heart failure patients including those who cannot undergo traditional cardiac resynchronization therapy CRT due to anatomical constraints vascular anatomy or other factors
LBBP can be considered as an alternative resynchronization method for non-responders to traditional CRT
Practical Significance
The procedure is simpler less technically complex electrode fixation is easier the procedure duration and fluoroscopy time are shorter it has the ability to maintain and improve left ventricular synchrony and a shorter learning curve Inclusion Criteria
1 Male or female 18 years of age at Visit 1
2 patients with complete left bundle branch block QRS duration greater than 130 ms left ventricular ejection fraction LVEF less than 35 and New York Heart Association NYHA functional class 2-3 who have been ineffective on optimal medical therapy for at least 3 months
3 Written informed consent and assent when applicable obtained from subject or subjects legal representative and ability for subject to comply with the requirements of the study
Exclusion Criteria
1 Pregnancy
2 Psychic disturbances
3 Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data - life expectancy less than 1 year
Anticipated amount of patients - 50 STUDY TREATMENTS AND INTERVENTIONS day 1 - admission to cardiology department acquisition of medical history physical examination blood tests ECG transthoracic echoCG
day 2 - additional examinations if necessary depend on comorbidity preparing for interventional procedure
day 3 - implantation of cardiac resynchronization therapy device using Left bundle branch area pacing LBBAP
Procedure description
LBBAP procedure was performed as previously described by Huang in 2017 and Ponnusamy in 2022 Monitoring of 12-lead ECG and intracardiac electrograms were performed utilizing WorkMate Claris electrophysiology system Abbott Plymouth MN DF-1 Implantable cardioverter-defibrillator ICD lead was placed into the right ventricle RV apex in all patients LBBAP was performed using two types of leads and delivery catheters C315HIS sheath with 3830 SelectSecure lead Medtronic Minneapolis MN and Selectra 3D with Solia S60 lead Biotronik Berlin Germany Left conduction system capture was confirmed in appliance with European Heart Rhythm Association EHRA clinical consensus statement on conduction system pacing implantation 10 Main criteria to accept LBB area capture were presence of terminal R-wave in lead V1 transition in QRS morphology from non-selective to selective during threshold test short and stable V6 R-wave peak time V6RWPT80 ms in different pacing outputs V6-V1 interpeak33 ms sudden increase in V1 R-wave peak time V1RWPT10 ms split of EGM during threshold test
day 4 - chest X-ray device pocket ultrasound device interrogation with lead testing ECG
day 5 - discharge from the hospital
A Schedule of Events representing the required testing procedures to be performed for the duration of the study is diagrammed in Appendix 1
Prior to conducting any study-related activities written informed consent must be signed and dated by the subject or subjects legal representative If appropriate assent must also be obtained prior to conducting any study-related activities
EVALUATIONS BY VISIT Visit 1 admission to the hospital
1 Review the study with the subject subjects legal representative and obtain written informed consent
2 Assign the subject a unique screening number
3 Record demographics data
4 Record medical history including a history of congestive heart failure diagnosis date and prior treatments
5 Record concomitant medications
6 Perform a complete physical examination
7 Perform and record vital signs
8 Perform and record oximetry
9 Perform and record results of blood pressure testing
10 Collect blood for clinical laboratory tests chemistry hematology prothrombin time NTPROBNP
11 Obtain an echocardiogram ECG
12 Obtain a chest x-ray
13 Implantation of device
14 Chest X-ray ECG and device telemetry at 1 day after procedure
15 Discharge from the hospital and schedule subject for Visit 2 in 3 months Visit 2 3 months after discharge
1 Record any Adverse Experiences andor Review subject diary for adverse experiences 2 Perform abbreviated physical examination 3 Perform and record vital signs 4 Obtain an echocardiogram ECG chest X-ray 5 NTproBNP test 6 minute walk test 6MWT 7 Questionnaire-based assessments SF-36 EQ-5D-5L 8 Device telemetry Visit 3 6 months after discharge
1 Record any Adverse Experiences andor Review subject diary for adverse experiences
2 Perform abbreviated physical examination
3 Perform and record vital signs
4 Obtain an echocardiogram ECG chest X-ray
5 NTproBNP test
6 6MWT
7 Questionnaire-based assessments SF-36 EQ-5D-5L
8 Device telemetry Visit 4 12 months after discharge
1 Record any Adverse Experiences andor Review subject diary for adverse experiences 2 Perform abbreviated physical examination 3 Perform and record vital signs 4 Obtain an echocardiogram ECG chest X-ray 5 NTproBNP test 6 6MWT 7 Questionnaire-based assessments SF-36 EQ-5D-5L 8 Device telemetry
STATISTICAL METHODS AND CONSIDERATIONS This will be a non-randomized prospective single-centre observational study Participant characteristics and sequencing results will be summarized with descriptive statistics including medians averages and standard deviations for continuous data For categorical data proportions with a 95 confidence interval will be calculated by the Klopper-Pearson method Demographic clinical and pathological characteristics will be compared using the criterion χ2 categorical variables and t-testanalysis of variance continuous variablesValues of p005 will be considered significant
DATA COLLECTION RETENTION AND MONITORING Data Collection Instruments The Investigator will prepare and maintain adequate and accurate source documents designed to record all observations and other pertinent data for each subject treated with the study drug
Study personnel will enter data from source documents corresponding to a subjects visit into the protocol-specific electronic Case Report Form eCRF and paper CRF when the information corresponding to that visit is available Subjects will not be identified by name in the study database but will be identified by a site number subject number and initials
For eCRFs If a correction is required for an eCRF the time and date stamps track the person entering or updating eCRF data and creates an electronic audit trail For paper CRFs If a correction is made on a CRF the study staff member will line through the incorrect data write in the correct data and initial and date the change
The Investigator is responsible for all information collected on subjects enrolled in this study All data collected during the course of this study must be reviewed and verified for completeness and accuracy by the Investigator A copy of the CRF will remain at the Investigators site at the completion of the study
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