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This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed.
Heart failure (HF) is a serious condition that affects a lot of people and places a significant burden on the healthcare system. Some HF patients also have issues with the natural electrical system of their heart, causing uneven heart contractions and worsening heart function. A treatment known as CRT has been helping such patients, but it does not work for everyone. A new technique called conduction system pacing (CSP) has emerged that might offer a more natural way of maintaining heart contractions.
This study aims to determine if CSP can enhance the ability of HF patients to exercise, by looking at their maximum oxygen consumption (a measure of exercise capacity). It will also explore why some HF patients struggle with exercise more than others. Eligible patients will be randomly assigned to either the new CSP treatment or a standard pacing method (right ventricular apical pacing). Patients will be checked regularly over a follow-up period of 24 weeks.
The main goal is to see if patients can exercise better with CSP after 24 weeks. The study will also look at other heart measures and safety concerns related to the devices. This study might show that CSP can help improve exercise capacity and heart function in certain HF patients. The results could guide health care professionals in offering better, tailored treatments for their patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conduction system pacing | Experimental | In the conduction system pacing group, the right ventricular lead will be placed in a septal position to achieve conduction system pacing, either His bundle pacing (HBP) or left bundle branch area (LBBA) pacing. |
|
| Right ventricular apical pacing | Active Comparator | Control group, in this group patients will receive a pacemaker with the ventricular lead in the right ventricle apex. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conduction system pacing | Device | In the conduction system pacing group, the right ventricular lead will be placed in a septal position to achieve conduction system pacing, either His bundle pacing (HBP) or left bundle branch area (LBBA) pacing. In the usual care group, the right ventricular lead will be placed in the right ventricle apex as usual. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | Change of VO2 peak from baseline to 24 weeks | 24 weeks after pacemaker implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | Change of VO2 peak from baseline to 4 weeks | 4 weeks after pacemaker implantation |
| Echocardiographic parameters (Ejection Fraction) | Change from baseline to 4,12 and 24 weeks (EF%) |
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Inclusion Criteria:
Patients with heart failure as defined by European Society of Cardiology guidelines
Exclusion Criteria:
Severe chronic kidney disease (eGFR ≤20 mL/kg/min or dialysis) , severe chronic obstructive pulmonary disease (≥GOLD 3) , active malignancy ...
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Gevaert | Contact | 038213538 | Andreas.gevaert@uza.be | |
| Faro Verelst | Contact | 038213538 | Faro.verelst@uza.be |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Gevaert | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Recruiting | Edegem | Antwerp | 2650 | Belgium |
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|
| Right ventricular apical pacing | Device | This is the usual care group. Patients will receive a pacemaker device with the right ventricular lead inserted in the apex and not in the septal position. |
|
| 4, 12 and 24 weeks after pacemaker implantation |
| QRS width | Change from baseline to 4,12,24 weeks (msec) | 4, 12 and 24 weeks after pacemaker implantation |
| Biomarker, N-terminal pro B-type natriuretic peptide levels | Change from baseline to 4, 24 weeks (pg/ml) | 4 and 24 weeks after pacemaker implantation |
| Health-related quality of life scores | KCCQS - Kansas City cardiomyopathy quality score | 4,12 and 24 weeks after pacemaker implantation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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