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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:
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 heart's 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:
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:
- 1:1 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 parameters/endpoints:
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:
The long-term effect of accelerated pacing on:
Symptoms experienced as a result of (accelerated) pacing based on the AFEQT questionnaire
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated pacing (lower rate pacemaker 80bpm) | Experimental | Patients in the experimental arm will have their pacemaker programmed to a lower rate of 80bpm. |
|
| Current standard of care (lower rate pacemaker 60bpm) | Active Comparator | Patients in the control arm will have their pacemaker programmed to a lower rate of 60bpm, which is the current standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated pacing | Device | The lower rate of the pacemaker will be programmed to 80 bpm in DDDR mode with mode switch to DDIR mode. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP. | The primary endpoint of this study is the difference in HRQoL, measured with the Minnesota Living with Heart Failure Questionnaire (MLHFQ), between patients programmed to accelerated pacing with a lower rate of 80 bpm (intervention) compared to current standard of care with a lower rate of 60 bpm (control). The score in the MLHFQ can range between 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. | 6 months after the AV node ablation |
| Measure | Description | Time Frame |
|---|---|---|
| The acute hemodynamic effects of different (accelerated) pacing rates on pulmonary capillary wedge pressure (PCWP). | The acute effect of various accelerated pacing rates on PCWP measured by a right heart catheterization during the AV node ablation procedure among AF patients undergoing a pace-and-ablate strategy with LBBAP. | At the AV node ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Vernooy, MD, PhD | Contact | +31433877095 | kevin.vernooy@mumc.nl |
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Randomized, single center, prospective, single blinded, parallel group, pilot-trial.
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| Current standard of care | Device | The lower rate of the pacemaker will be programmed to the current standard of care which is 60 bpm in DDDR mode with mode switch to DDIR mode. |
|
| The acute hemodynamic effects of different (accelerated) pacing rates on cardiac output (CO). | The acute effect of various accelerated pacing rates on CO measured by a right heart catheterization during the AV node ablation procedure among AF patients undergoing a pace-and-ablate strategy with LBBAP. | At the AV node ablation |
| The acute hemodynamic effects of different (accelerated) pacing rates on arterial blood pressure. | The acute effect of various accelerated pacing rates on arterial blood pressure measured invasively in the femoral artery during the AV node ablation procedure among AF patients undergoing a pace-and-ablate strategy with LBBAP. | At the AV node ablation |
| The long-term effects of accelerated pacing on health-related quality of life based on the 36-item short form health survey (SF-36) among AF patients undergoing pace-and-ablate strategy. | The long-term (6 months) effects of accelerated pacing on HRQoL measured by the SF-36 questionnaire. | 6 months after the AV node ablation |
| The long-term effects of accelerated pacing on NTproBNP levels among AF patients undergoing pace-and-ablate strategy. | The long-term (6 months) effects of accelerated pacing on NTproBNP levels. | 6 months after the AV node ablation |
| The long-term effects of accelerated pacing on device detected AF burden among AF patients undergoing pace-and-ablate strategy. | The long-term (6 months) effects of accelerated pacing on device detected AF burden. | 6 months after the AV node ablation |
| The long-term effects of accelerated pacing on device detected daily activity among AF patients undergoing pace-and-ablate strategy. | The long-term (6 months) effects of accelerated pacing on device detected daily activity. | 6 months after the AV node ablation |
| The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. | The long-term (6 months) effects of accelerated pacing on LVEF. | 6 months after the AV node ablation |
| The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. | The long-term (6 months) effects of accelerated pacing on LVEDD. | 6 months after the AV node ablation |
| The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. | The long-term (6 months) effects of accelerated pacing on LVESD. | 6 months after the AV node ablation |
| The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. | The long-term (6 months) effects of accelerated pacing on LAVI. | 6 months after the AV node ablation |
| The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. | The long-term (6 months) effects of accelerated pacing on LA-strain. | 6 months after the AV node ablation |
| Palpitations experienced as a result of (accelerated) pacing. | Palpitations experienced as a result of (accelerated) pacing based on the AF effect on quality of life (AFEQT) questionnaire. Patients can score between 0 and 100, with a lower score meaning a worse outcome. | 6 months after the AV node ablation |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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