Permanent Conduction System Pacing Versus Atrioventricular Management for Patients With Wide QRS and Patent AV Conduction

ConditionBradycardia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorÓscar Cano Pérez

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age > 18 years

Any indication for cardiac pacing with an expected VP burden ≤ 10% after 1- month run-in period

Baseline wide QRS (≥150 ms) with normal PR or QRS ≥ 130 ms + PR≥230 ms

LVEF≥50%

Disqualifiers

Pregnant woman

Permanent or long-lasting atrial fibrillation

Previous PM/ICD

Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Angioplasty (PCI), surgical valve repair or replacement within 90 days prior enrollment

Trial design

Design model

Crossover

Treatments tested in this trial

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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: CSP ONActive comparator 1 intervention

Group B: CSP OFFPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Percentage of patients with LVEF decrease ≥10% and/or ≥ 15% decrease in GLS at 12-month follow-up measured by echocardiographic evaluation

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Óscar Cano Pérez

Lead sponsor

Spanish Society of Cardiology

Sponsor institution

Source ClinicalTrials.gov

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