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 @ 12:46 PM
Ignite Modification Date: 2025-12-25 @ 12:14 PM
NCT ID: NCT01401361
Description: 150 subjects who met Inc./Excl. criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 received the device. 3 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.
Frequency Threshold: 5
Time Frame: None
Study: NCT01401361
Study Brief: Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Arm Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement . None None 3 134 10 134 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intermittent High Grade AV Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Transient Ischemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View