Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620705
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pacing Away from Heart Failure Left Bundle Branch Area Pacing or Biventricular Pacing in Patients with Atrial Fibrillation and Left Ventricular Dysfunction
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is unknown whether left bundle branch area pacing LBBAP or biventricular pacing best prevents or reverses left ventricular LV adverse remodelling in patients with atrial fibrillation AF who require ventricular pacing or CRT This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction
Detailed Description:
Rationale Patients with atrial fibrillation AF and left ventricular LV dysfunction may require ventricular pacing because of bradycardia AV junction ablation or for cardiac resynchronization therapy Right ventricular RV pacing is associated with the risk of adverse LV remodelling and heart failure in particular in those with pre-existing LV dysfunction Both LBBAP and biventricular pacing can prevent LV dyssynchrony It is unknown which pacing mode best prevents or reverses LV adverse remodelling in patients with AF who require ventricular pacing or CRT
Primary objectives
1 To compare LVESV change between LBBAP and biventricular pacing in patients with AF and LV dysfunction
Secondary objectives
2 To compare change in quality of life New York Heart Association functional class 6-minute walking distance QRS duration vectorcardiographic QRS area left ventricular ejection fraction LVEF global longitudinal strain and NT-proBNP between LBBAP and biventricular pacing in patients with AF and LV dysfunction
Study design Randomized patient and assessor blinded non-inferiority cross-over trial
Study population Patients with permanent AF and LVEF lt 50 who require ventricular pacing because of bradycardia AV junction ablation or CRT
Intervention Patients will be randomized according to a crossover design to first 6 months of LBBAP and then 6 months of biventricular pacing or vice versa
After finishing the randomization phase of the study at 12 months patients will be followed according to routine clinical practice Clinical follow-up an ECG device interrogation and echocardiography will be performed at 36 months 2 years after finishing the randomization phase in all patients
Main study parametersendpoints New York Heart Association NYHA functional class Minnesota Living with Heart Failure Questionnaire MLHFQ 6-minute walking distance ECG vectorcardiographic QRS area QRS duration echocardiography LVESV LVEF global longitudinal strain NT-proBNP lead and device performance sensing pacing expected battery life complications and costs will be evaluated for each pacing mode
Nature and extent of the burden and risks associated with participation benefit and group relatedness For the purpose of this randomized controlled trial patients will also receive a LBBAP lead The additional risk of serious adverse events is 15 lead dislodgement 11 04 acute coronary syndrome all managed conservatively without further sequelae in prior studies1 Patients who participate in the trial will have 3 extra follow-up visits 4 extra questionnaires 3 extra ECGs 3 extra device interrogations 3 extra echocardiograms and 4 extra blood samples 5 mL each
Primary objectives
1 To compare LVESV change between LBBAP and biventricular pacing in patients with AF and LV dysfunction
Secondary objectives
2 To compare change in quality of life New York Heart Association functional class 6-minute walking distance QRS duration vectorcardiographic QRS area left ventricular ejection fraction LVEF global longitudinal strain and NT-proBNP between LBBAP and biventricular pacing in patients with AF and LV dysfunction
Study design Randomized patient and assessor blinded non-inferiority cross-over trial
Study population Patients with permanent AF and LVEF lt 50 who require ventricular pacing because of bradycardia AV junction ablation or CRT
Intervention Patients will be randomized according to a crossover design to first 6 months of LBBAP and then 6 months of biventricular pacing or vice versa
After finishing the randomization phase of the study at 12 months patients will be followed according to routine clinical practice Clinical follow-up an ECG device interrogation and echocardiography will be performed at 36 months 2 years after finishing the randomization phase in all patients
Main study parametersendpoints New York Heart Association NYHA functional class Minnesota Living with Heart Failure Questionnaire MLHFQ 6-minute walking distance ECG vectorcardiographic QRS area QRS duration echocardiography LVESV LVEF global longitudinal strain NT-proBNP lead and device performance sensing pacing expected battery life complications and costs will be evaluated for each pacing mode
Nature and extent of the burden and risks associated with participation benefit and group relatedness For the purpose of this randomized controlled trial patients will also receive a LBBAP lead The additional risk of serious adverse events is 15 lead dislodgement 11 04 acute coronary syndrome all managed conservatively without further sequelae in prior studies1 Patients who participate in the trial will have 3 extra follow-up visits 4 extra questionnaires 3 extra ECGs 3 extra device interrogations 3 extra echocardiograms and 4 extra blood samples 5 mL each
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None