NCT05887323

LBBAP Data Collection Registry

Completed Results posted Last updated 8 October 2024

What this trial tests

trial testing Implantation of the Tendril 2088 lead in the LBBA in Bradycardia in 221 participants. Completed in 11 July 2023.

Timeline

25 April 2023

Primary endpoint
11 July 2023

11 July 2023

Quick facts

Lead sponsor	Abbott Medical Devices
Status	Completed
Study type	OBSERVATIONAL
Enrollment	221
Start date	25 April 2023
Primary completion	11 July 2023
Estimated completion	11 July 2023
Sites	11 locations across France, Italy, Singapore, United States, India

Drugs / interventions tested

• Implantation of the Tendril 2088 lead in the LBBA

Conditions studied

• Bradycardia — all drugs for Bradycardia →
• Sinus Node Dysfunction — all drugs for Sinus Node Dysfunction →
• Heart Block — all drugs for Heart Block →
• Syncope — all drugs for Syncope →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Bradycardia or Sinus Node Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs). Primary · 6 months after the implantation

The primary safety endpoint evaluates a LBBAP lead related SADE rate which is an appropriate measure for safety and consistent with the primary safety endpoints used for evaluating performance of the transvenous right ventricular lead.

Group	Value	95% CI
Left Bundle Branch Area Implant	220

The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP Primary · 6 months after the implantation

The primary effectiveness endpoint evaluates the ability to pace and sense when the TendrilTM STS 2088 lead is implanted in the LBBA. This analysis was performed on the successfully implanted population.

Group	Value	95% CI
Left Bundle Branch Area Implant	187

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Left Bundle Branch Area Implant

Serious: 5/221 (2%)

Deaths: 5/221

Serious adverse events (3 terms)

Reaction	System	Left Bundle Branch Area Im…
Heart Failure	Cardiac disorders	—
Acute Decompensated Heart Failure	Cardiac disorders	—
Lead Dislodgement or Migration	Product Issues	—

Other adverse events (4 terms — click to expand)

Reaction	System	Left Bundle Branch Area Im…
Developed Atrial Fibrillation with Atrial Lead	Cardiac disorders	—
Mechanical Bump to Right Bundle Branch Resulting in Complete Heart Block	Cardiac disorders	—
Bruising and Swelling at Insertion Site	General disorders	—
Hematoma	Vascular disorders	—

Most-reported serious reactions: Heart Failure, Acute Decompensated Heart Failure, Lead Dislodgement or Migration.

Data from ClinicalTrials.gov NCT05887323 adverse events section.

Sponsor's own description

The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.