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Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up

ConditionsBradycardiaAtrioventricular BlockSinus Node DysfunctionBundle-Branch Block
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

About this trial

The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in patients with bradycardia who need a pacemaker.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects intended to undergo initial (de novo) pacing system implant using the INGEVITY+ lead in the left bundle branch area (LBBA) and a Boston Scientific single or dual- chamber pacemaker (Note: no prior attempted pacing system components);

Symptomatic paroxysmal or permanent second- or third-degree AV block,

Symptomatic bilateral bundle branch block,

Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block),

Disqualifiers

Subjects meeting guideline indications for cardiac resynchronization therapy (CRT) in the absence of a bradycardia indication;

Subjects with a known or suspected sensitivity to dexamethasone acetate (DXA);

Subjects with a Mechanical Tricuspid Valve;

Subjects requiring hemodialysis or peritoneal dialysis;

Trial population

Subjects included in SEPTA PMCF will be selected from the physician investigator's general patient population with a brady pacing indication for single or dual-chamber pacemaker implantation where LBBAP is preferred. Diverse racial and gender patient consideration should be implemented when determining potential participants.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pacemaker lead

    Device

    The pacemaker lead under investigation is a bipolar, steroid-releasing pacemaker electrode with active fixation (IS-1 connection) designed for chronic stimulation and sensing in the right atrium, right ventricle or left bundle branch area (LBBA). In this study, the lead is implanted in the LBBA and connected to a single- or dual-chamber pacemaker. Implantation is performed using a compatible, CE-marked catheter for pacemaker implantation.

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Patients receiving INGEVITY+ lead for left bundle branch area pacing1 intervention

Trial outcomes

Primary outcomes

1

LBBA Implant Success Rate

Percentage of subjects in whom the INGEVITY+ lead is successfully implanted in the left bundle branch area (LBBA). Implant success is determined by ECG and procedural criteria, as defined per protocol.

Time frame
At the time of implant procedure (Day 0).
2

Maintenance of Ventricular Synchrony (Paced QRS Duration)

Mean paced QRS duration measured by 12-lead ECG to assess preservation of ventricular synchrony.

Time frame
From implant through 3-year follow-up.

Secondary outcomes

Other outcomes

1

Lead-related Complication-Free Rate

Freedom from lead-related complications (death, serious injury, invasive correction, or permanent loss of device function).

Time frame
From implant through 3 years.

Sponsors and contacts

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Boston Scientific Corporation

Lead sponsor

Source ClinicalTrials.gov
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