Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05491655
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2022-08-04
Brief Title:
High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
Sponsor:
Miulli General Hospital
Organization:
Miulli General Hospital
Study Overview
Official Title:
High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
Status:
RECRUITING
Status Verified Date:
2023-11
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:
HIPPOS
Brief Summary:
Cardiac Resynchronization Therapy CRT decreases heart failure hospitalizations and mortality and increases left ventricular Ejection Fraction EF in patients with dilated cardiomyopathy left bundle branch block and QRS duration 130msec His bundle pacing has a similar effect in this category of patients However CRT is not beneficial in heart failure HF patients with narrow QRS His-bundle pacing delivers physiological ventricular activation and has been shown to improve acute hemodynamic function in patients with heart failure a prolonged PR interval and either a narrow QRS or RBBB through AV delay optimization We observed an acute hemodynamic effect during application of higher pacing output 35 Volts1 msec in HF patients with dilated or ischemic cardiomyopathy and narrow QRS independently of the paced QRS duration or AV delay shortening
This is a single-center prospective randomized single-blinded study recruiting a sub-population of patients with heart failure dilated or ischemic cardiomyopathy EF50 narrow QRS 110 msec in optimal medical treatment who have an indication for ICD
This is a single-center prospective randomized single-blinded study recruiting a sub-population of patients with heart failure dilated or ischemic cardiomyopathy EF50 narrow QRS 110 msec in optimal medical treatment who have an indication for ICD
Detailed Description:
Cardiac Resynchronization Therapy CRT decreases heart failure hospitalizations and mortality and increases left ventricular Ejection Fraction EF in patients with dilated cardiomyopathy left bundle branch block and QRS duration 130msec His bundle pacing has a similar effect in this category of patients However CRT is not beneficial in heart failure HF patients with narrow QRS His-bundle pacing delivers physiological ventricular activation and has been shown to improve acute hemodynamic function in patients with heart failure a prolonged PR interval and either a narrow QRS or Right Bundle Branch Block RBBB through atrioventricular AV delay optimization We observed an acute hemodynamic effect during application of higher pacing output 35 Volts1 msec in HF patients with dilated or ischemic cardiomyopathy and narrow QRS independently of the paced QRS duration or AV delay shortening
This is a single-center prospective randomized single-blinded study recruiting a sub-population of patients with heart failure dilated or ischemic cardiomyopathy EF50 narrow QRS 110 msec in optimal medical treatment who have an indication for ICD
All patients will be implanted with a CRT Cardiac Resynchronization Therapy defibrillator with one of the leads positioned on the His bundle to obtain direct His-bundle capture There will be a 1-month run-in period where the output voltage will be 35 Volts1 or 2V1msec according to the group so as to obtain stable threshold
A single-blinded design will then be employed to investigate the effect of His bundle pacing Patients will be allocated in random order to six-month treatment periods in each of the following two states 1 35 Volts1 msec pacing output direct His-bundle pacing AV delay will be programmed in order to obtain a PR interval of 120-140msec 2back up only pacing pacemaker programmed to VVI 30 bpm or AAIR-DDDR 60bpm Endpoint measurements will be taken at baseline 1 month run-in period of 35 Volts1 msec or 2V1msec pacing output and 6 months post randomization Treating Physicians will be aware of assignment in order to facilitate routine device follow-up Echocardiographic and electrocardiographic evaluation will be performed in a blinded manner Treatment allocation will be blinded to the endpoint assessor and the patient
Patients entering the study will attend for implantation of a CRT pacemaker device with one lead positioned on the His bundle This will be performed in Miulli General Hospital and other participating centres no later than 2 months after the patients screening visit
Before the intervention patients will be randomized to either receive active pacing treatment with 35 V1 msec or back up only pacing pacemaker programmed to VVI 30 bpm or AAIR-DDDR 60 for 6 months All patients will be implanted with an Implantable cardioverter defibrillator ICD and an ICD lead in the right ventricle RV either RV apex or RV septum In all patients a pacing lead will be positioned in the right atrium typically the right atrial appendage All patients will have a pacemaker lead positioned on the His bundle to obtain direct His-bundle capture
After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 35 Volts1msec or 2V1msec according to the assignment group
One month after patients are implanted with their device patients will either receive active pacing treatment with 35 V1 msec or back up only pacing pacemaker programmed to VVI 30 bpm or AAIR-DDDR 60bpm for 6 months Treatment allocation will be obtained using an Interactive Web Response System IWRS programmed with a randomization schedule provided by the trial statistician Appropriate blocking will be used
This is a single-center prospective randomized single-blinded study recruiting a sub-population of patients with heart failure dilated or ischemic cardiomyopathy EF50 narrow QRS 110 msec in optimal medical treatment who have an indication for ICD
All patients will be implanted with a CRT Cardiac Resynchronization Therapy defibrillator with one of the leads positioned on the His bundle to obtain direct His-bundle capture There will be a 1-month run-in period where the output voltage will be 35 Volts1 or 2V1msec according to the group so as to obtain stable threshold
A single-blinded design will then be employed to investigate the effect of His bundle pacing Patients will be allocated in random order to six-month treatment periods in each of the following two states 1 35 Volts1 msec pacing output direct His-bundle pacing AV delay will be programmed in order to obtain a PR interval of 120-140msec 2back up only pacing pacemaker programmed to VVI 30 bpm or AAIR-DDDR 60bpm Endpoint measurements will be taken at baseline 1 month run-in period of 35 Volts1 msec or 2V1msec pacing output and 6 months post randomization Treating Physicians will be aware of assignment in order to facilitate routine device follow-up Echocardiographic and electrocardiographic evaluation will be performed in a blinded manner Treatment allocation will be blinded to the endpoint assessor and the patient
Patients entering the study will attend for implantation of a CRT pacemaker device with one lead positioned on the His bundle This will be performed in Miulli General Hospital and other participating centres no later than 2 months after the patients screening visit
Before the intervention patients will be randomized to either receive active pacing treatment with 35 V1 msec or back up only pacing pacemaker programmed to VVI 30 bpm or AAIR-DDDR 60 for 6 months All patients will be implanted with an Implantable cardioverter defibrillator ICD and an ICD lead in the right ventricle RV either RV apex or RV septum In all patients a pacing lead will be positioned in the right atrium typically the right atrial appendage All patients will have a pacemaker lead positioned on the His bundle to obtain direct His-bundle capture
After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 35 Volts1msec or 2V1msec according to the assignment group
One month after patients are implanted with their device patients will either receive active pacing treatment with 35 V1 msec or back up only pacing pacemaker programmed to VVI 30 bpm or AAIR-DDDR 60bpm for 6 months Treatment allocation will be obtained using an Interactive Web Response System IWRS programmed with a randomization schedule provided by the trial statistician Appropriate blocking will be used
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