Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377046
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-20
Brief Title:
Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP a Randomized Controlled Pilot Trial
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Accelerated PACing for Improved Quality of lifE in Symptomatic Atrial Fibrillation Patients Undergoing Pace-and-ablate Strategy With Left Bundle Branch Area Pacing a Randomized Controlled Pilot Trial PACE-AF
Status:
NOT_YET_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:
PACE-AF
Brief Summary:
The goal of this clinical trial is to determine the effect of accelerated pacing pacemaker lower rate programmed to 80bpm compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation patients undergoing pace-and-ablate strategy with LBBAP
The main question it aims to answer is
- To determine the effect of accelerated pacing on health-related quality of life compared to the current standard of care
Secondary questions it aims to answer are
To study the acute hemodynamic effect of different accelerated pacing rates on pulmonary capillary wedge pressure cardiac output and arterial blood pressure among atrial fibrillation patients undergoing pace-and-ablate strategy
To study the long-term effects at 6 months of accelerated pacing compared to the current standard of care among atrial fibrillation patients undergoing pace-and-ablate strategy on
NT pro BNP levels
device detected atrial fibrillation burden and daily activity
echocardiographic measurements LVEF left ventricular ejection fraction LVEDD left ventricular end- diastolic diameter LVESD left ventricular end-systolic diameter LAVI left atrial volume index diastolic parameters strain
The main question it aims to answer is
- To determine the effect of accelerated pacing on health-related quality of life compared to the current standard of care
Secondary questions it aims to answer are
To study the acute hemodynamic effect of different accelerated pacing rates on pulmonary capillary wedge pressure cardiac output and arterial blood pressure among atrial fibrillation patients undergoing pace-and-ablate strategy
To study the long-term effects at 6 months of accelerated pacing compared to the current standard of care among atrial fibrillation patients undergoing pace-and-ablate strategy on
NT pro BNP levels
device detected atrial fibrillation burden and daily activity
echocardiographic measurements LVEF left ventricular ejection fraction LVEDD left ventricular end- diastolic diameter LVESD left ventricular end-systolic diameter LAVI left atrial volume index diastolic parameters strain
Detailed Description:
Rationale
Permanent pacemaker implantation combined with atrioventricular node ablation AVNA reduces symptoms and improves health-related quality of life HRQoL in patients with symptomatic atrial fibrillation AF A high percentage of conventional right ventricular pacing increases the risk for pacing-induced cardiomyopathy a risk which is presumably minimised by a form of conduction system pacing termed left bundle branch area pacing LBBAP LBBAP attempts to recreate the normal physiologic activation of the heart through stimulation of the hearts own natural conduction system thereby maintaining ventricular synchrony This strategy may be particularly important in patients with heart failure with preserved ejection fraction HFpEF a diagnosis that frequently coexists with AF The long-term programming of a patient undergoing a pace-and-ablate strategy pacemaker implantation and AVNA is such that the lower rate of the pacemaker is routinely set to 60 bpm Previous studies have shown that accelerated pacing ie programming the pacemaker to a lower rate of 80bpm may improve HRQoL in a subset of patients with HFpEF It is therefore hypothesized that accelerated pacing will improve HRQoL in patients with symptomatic AF undergoing a pace and ablate strategy when compared to pacing at 60 bpm which is standard of care
Objective
Primary objective To determine the effect of accelerated pacing lower programmed rate of 80 bpm compared to pacing at the standard programmed rate of 60 bpm on HRQoL in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP
Secondary objectives
To study in a subset of participants who give informed consent the acute hemodynamic effect of accelerated pacing rates on pulmonary capillary wedge pressure PCWP cardiac output and arterial blood pressure among AF patients undergoing a pace-and-ablate strategy with LBBAP
To study the long-term 6 months effects of accelerated pacing among AF patients undergoing a pace-and-ablate strategy with LBBAP by measuring NT-proBNP levels device detected AF-burden and daily activity by evaluating HRQoL questionnaires SF-36 and by assessing echocardiographic measurements LVEF left ventricular ejection fraction LVEDD left ventricular end-diastolic diameter LVESD left ventricular end-systolic diameter LAVI left atrial volume index diastolic parameters strain compared to pacing at the standard of care lower rate of 60bpm
To investigate whether participants experience symptoms of accelerated pacing such as palpitations based on the Atrial Fibrillation Effect on Quality-of-life AFEQT questionnaire compared to standard of care
Study design
Randomized single center prospective single blinded parallel group pilot-trial
Study population
Patients 18 years with symptomatic AF undergoing pace-and-ablate strategy
Intervention
- 11 randomization to a lower rate of DDDR 80 bpm intervention or a lower rate of DDDR 60 bpm control Duration of the study is 6 months
In a subset of participants
- Right heart catheterisation and invasive blood pressure measurements will be conducted to evaluate acute hemodynamic effects of different accelerated ventricular pacing rates during the standard of care AV node ablation
Main study parametersendpoints
Primary endpoint
Difference in HRQoL between a lower rate of 80 bpm and a lower rate of 60 bpm based on the Minnesota Living with Heart Failure Questionnaire MLHFQ determined at 6 months follow-up
Secondary endpoints
The acute hemodynamic effects of accelerated pacing at time of AVNA
Pulmonary Capillary Wedge Pressure PCWP
Cardiac Output CO
Systemic arterial blood pressure
The long-term effect of accelerated pacing on
HRQoL based on the MLHFQ and SF-36 questionnaires
NT-proBNP levels
Device detected AF burden
Device detected daily activity comparing accelerated- vs control rate
Echocardiographic measurements LVEF LVEDD LVESD LAVI LA strain
Symptoms experienced as a result of accelerated pacing based on the AFEQT questionnaire
Permanent pacemaker implantation combined with atrioventricular node ablation AVNA reduces symptoms and improves health-related quality of life HRQoL in patients with symptomatic atrial fibrillation AF A high percentage of conventional right ventricular pacing increases the risk for pacing-induced cardiomyopathy a risk which is presumably minimised by a form of conduction system pacing termed left bundle branch area pacing LBBAP LBBAP attempts to recreate the normal physiologic activation of the heart through stimulation of the hearts own natural conduction system thereby maintaining ventricular synchrony This strategy may be particularly important in patients with heart failure with preserved ejection fraction HFpEF a diagnosis that frequently coexists with AF The long-term programming of a patient undergoing a pace-and-ablate strategy pacemaker implantation and AVNA is such that the lower rate of the pacemaker is routinely set to 60 bpm Previous studies have shown that accelerated pacing ie programming the pacemaker to a lower rate of 80bpm may improve HRQoL in a subset of patients with HFpEF It is therefore hypothesized that accelerated pacing will improve HRQoL in patients with symptomatic AF undergoing a pace and ablate strategy when compared to pacing at 60 bpm which is standard of care
Objective
Primary objective To determine the effect of accelerated pacing lower programmed rate of 80 bpm compared to pacing at the standard programmed rate of 60 bpm on HRQoL in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP
Secondary objectives
To study in a subset of participants who give informed consent the acute hemodynamic effect of accelerated pacing rates on pulmonary capillary wedge pressure PCWP cardiac output and arterial blood pressure among AF patients undergoing a pace-and-ablate strategy with LBBAP
To study the long-term 6 months effects of accelerated pacing among AF patients undergoing a pace-and-ablate strategy with LBBAP by measuring NT-proBNP levels device detected AF-burden and daily activity by evaluating HRQoL questionnaires SF-36 and by assessing echocardiographic measurements LVEF left ventricular ejection fraction LVEDD left ventricular end-diastolic diameter LVESD left ventricular end-systolic diameter LAVI left atrial volume index diastolic parameters strain compared to pacing at the standard of care lower rate of 60bpm
To investigate whether participants experience symptoms of accelerated pacing such as palpitations based on the Atrial Fibrillation Effect on Quality-of-life AFEQT questionnaire compared to standard of care
Study design
Randomized single center prospective single blinded parallel group pilot-trial
Study population
Patients 18 years with symptomatic AF undergoing pace-and-ablate strategy
Intervention
- 11 randomization to a lower rate of DDDR 80 bpm intervention or a lower rate of DDDR 60 bpm control Duration of the study is 6 months
In a subset of participants
- Right heart catheterisation and invasive blood pressure measurements will be conducted to evaluate acute hemodynamic effects of different accelerated ventricular pacing rates during the standard of care AV node ablation
Main study parametersendpoints
Primary endpoint
Difference in HRQoL between a lower rate of 80 bpm and a lower rate of 60 bpm based on the Minnesota Living with Heart Failure Questionnaire MLHFQ determined at 6 months follow-up
Secondary endpoints
The acute hemodynamic effects of accelerated pacing at time of AVNA
Pulmonary Capillary Wedge Pressure PCWP
Cardiac Output CO
Systemic arterial blood pressure
The long-term effect of accelerated pacing on
HRQoL based on the MLHFQ and SF-36 questionnaires
NT-proBNP levels
Device detected AF burden
Device detected daily activity comparing accelerated- vs control rate
Echocardiographic measurements LVEF LVEDD LVESD LAVI LA strain
Symptoms experienced as a result of accelerated pacing based on the AFEQT questionnaire
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