Left Bundle Branch Versus Minimized Ventricular Pacing in Patients With Sick Sinus Syndrome and Prolonged AV Interval

ConditionsSick Sinus Syndrome Atrioventricular Nodal Dysfunction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAsan Medical Center

About this trial

The goal of this clinical trial is to compare two pacemaker strategies: Left Bundle Branch Area Pacing (LBBAP) and Minimized Ventricular Pacing (MVP) in patients requiring a permanent pacemaker for sick sinus syndrome and prolonged AV interval. It will also evaluate the safety and feasibility of the LBBAP method in these patients.

The main questions it aims to answer is:

\*Is LBBAP with physiological AV interval better than Minimized Ventricular Pacing?

Researchers will compare the LBBAP group (aiming for conduction system capture with physiological AV intervals) to the MVP group (aiming to minimize ventricular pacing with prolonged AV intervals) to evaluate the optimal pacing strategy.

Participants will:

* Be randomly assigned to either the LBBAP group or the MVP group. * Undergo a pacemaker implantation procedure according to the specific criteria for their assigned group. * Visit the clinic for regular checkups to measure pacing function and ensure the device settings remain compliant with the study protocol.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>18 years old

Sinus node dysfunction with symptoms

Atrioventricular conduction delay (PR interval > 200ms)

Disqualifiers

Subject was unable to provide written informed consent or participate in long-term follow-up.

Permanent atrial fibrillation

Pre-existing cardiac implantable electronic device

Persistent advanced atrioventricular conduction disturbance (2:1 block, Mobitz type II, or 3rd degree)

Trial design

Design model

Parallel

Treatments tested in this trial

LBBAP
Device
* All pacemaker implantation should be performed in standard manner. * A lead should be placed in the right atrial appendage or septum where acceptable sensing (P wave \>1mV) and pacing threshold (\<1V at 0.4ms width). * V lead should be placed in the right ventricular septum where conduction system pacing can be achieved with acceptable sensing and pacing threshold. The pacing morphology should be compatible with His bundle pacing, right ventricular pacing, selective and non-selective left bundle branch pacing, or left fascicular pacing. * The primary objective for the LBBAP group is the achievement of conduction system capture with LBBAP. However, based on the physician's discretion or the situations in the operating room, His bundle pacing can be accepted as alternatives to LBBAP.
MVP
Device
* All pacemaker implantation should be performed in standard manner. * A lead should be placed in the right atrial appendage or septum where acceptable sensing (P wave \>1mV) and pacing threshold (\<1V at 0.4ms width). * V lead should be placed in the right ventricular apex or septum where acceptable sensing (R wave \>5mV) and pacing threshold (\<1V at 0.4ms width) * The rhythmiQTM mode should be turned on * Sensing and pacing AV intervals recommended to be \>300ms (default value or more), and should not be \<200ms to minimize the ventricular pacing.

Treatment groups

440 Participants

are divided into 2 treatment groups

Group A: LBBAPExperimental treatment 1 intervention

Group B: MVPActive comparator 1 intervention

Trial outcomes

Primary outcomes

Rate of composite of all-cause mortality, heart failure hospitalization and persistent atrial fibrillation

* All cases of mortality after randomization will be counted. * Worsening heart failure includes heart failure hospitalization or urgent heart failure visit (outpatient or emergency department) * Persistent atrial fibrillation is defined when there are at least seven consecutive days with 22 hours of device-recorded AF per day or at least one day with an episode of AF lasting at least 22 hours, which is interrupted by electrical or chemical cardioversion.

Time frame

2 years

Secondary outcomes

- All cause mortality

All cases of mortality after randomization will be counted.

Time frame

2 years

- Ischemic stroke or systemic embolism

Composite of ischemic stroke or systemic embolism during follow-up

Time frame

2 years

Heart failure rehospitalization

* The patient is admitted to the hospital with a primary diagnosis of HF * The patient's length-of-stay in hospital extends for at least 24 hours * The patient exhibits documented at least one new or worsening symptoms due to HF on presentation * The patient has objective evidence of new or worsening HF, consisting of at least two physical examination findings or one physical examination and one laboratory criterion. * The patient receives at least one of the following treatments specifically for HF

Time frame

2 years

Any rehospitalization

Any rehospitalization after randomization

Time frame

2 years

Other outcomes

Periprocedural complications

Complications related to the procedure

Time frame

Periprocedural

Incidence of subclinical AF with pre-specified durations

AF lasting \>5min, \>1 hour, \>6 hours, \>1 day, and \>7 days

Time frame

2 years

Procedural success

Achievement of LBB area pacing (%)

Time frame

Periprocedural

Sponsors and contacts

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

Asan Medical Center

Lead sponsor

Severance Hospital

Collaborator

Samsung Medical Center

Collaborator

Seoul National University Hospital

Collaborator

Source ClinicalTrials.gov

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