Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 11:42 PM
Ignite Modification Date: 2025-12-25 @ 9:33 PM
NCT ID: NCT05646251
Description: Patients will be asked about adverse events related to the use of the echocardiography. Only echocardiogram related adverse event will be collected and reported and then assessed if it is procedure related, as well as all-cause mortality and serious adverse events.
Frequency Threshold: 0
Time Frame: Adverse events were collected during study participation up to final study visit at 3 months post implant.
Study: NCT05646251
Study Brief: Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EC-LBBAP Participant A heart ultrasound will be used during a pacemaker implant procedure 0 None 0 20 0 20 View
Control Participant A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm. 0 None 0 30 0 30 View
ECLBBAP Handheld Participant A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):