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Intraventricular conduction delay alone or in combination with AV conduction delay is associated with a dyssynchronous activation of the ventricles and may result in LV function impairment.
Conduction system pacing can restore physiologic ventricular activation in the presence of intraventricular and atrioventricular conduction delays.
Patients with intraventricular conduction delay alone or in combination with AV conduction delay who have a permanent pacemaker indication due to intermittent bradycardia and have predominantly intact AV conduction may benefit from continuous CSP.
Study design: Multicenter, prospective, randomized, cross-over, patient-blinded study
Study Objectives:
Study population criteria
Sample size: 120 patients will be enrolled in the study.
Devices: Only CE-marked pacemaker devices locally approved and commercially available shall be used in this protocol.
Statistical considerations: Once patients have signed the informed consent at baseline visit, patients will be considered as "Enrolled population" in the statistical analysis.
The sample size is based on the primary endpoint: LVEF decrease ≥ 10% and/or ≥ 15% decrease in GLS at 12-month follow- up with respect to baseline value.
Accounting for an attrition rate of 15% due to lost to follow-up or cross-over and considering the block size for randomization, 120 patients shall be enrolled
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSP ON | Active Comparator | Continuous Conduction System Pacing (CSP) |
|
| CSP OFF | Placebo Comparator | Non active Conduction System Pacing (CSP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker implant | Device | All patients will receive a ventricular lead in the conduction system (HBP or LBBAP) using conventional implant techniques described elsewhere. The pacemaker device and leads should be implanted according to the physician's manual provided with the devices. Only locally approved Medtronic PM generators with MVP algorithms will be used during the study. Investigators will use the Medtronic Select Secure 3830 lead for CSP. Acceptable LBBAP threshold should be <2,5V@0,5ms. Other commercially available stylet driven leads may be used as bail-out strategy only when CSP cannot be achieved with the 3830 lead at the implanting physician discretion. During the implant procedure lead impedances, pacing and sensing parameters will be measured using a pacing system analyzer (PSA). It is strongly encouraged the designation of a single and experienced CSP implanting physician at each center. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with LVEF decrease ≥10% and/or ≥ 15% decrease in GLS at 12-month follow-up measured by echocardiographic evaluation | Percentage of patients with LVEF decrease ≥10% and/or ≥ 15% decrease in GLS at 12-month follow-up measured by echocardiographic evaluation | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Óscar Cano, MD, PhD | Contact | +34 961244000 | 440079 | cano_osc@gva.es |
| Bernabé López, MD | Contact | +34 961244000 | 412713 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | Andalusia | 18014 | Spain |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| Hospital Clínico Universitario Lozano Blesa | Recruiting | Zaragoza | Aragon | 50009 | Spain |
|
| Hospital Universitari i Politècnic La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |