Trial Outcomes & Findings for ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization (NCT NCT03370536)

NCT ID: NCT03370536

Last Updated: 2020-02-10

Results Overview

Freedom from recurrent At/AF

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: at 12 months
• Results posted on: 2020-02-10

Participant Flow

Participant milestones

Measure	Patients With AF Patients with AF and planned to undergo first catheter procedure CardioInsight ECGI Mapping System: The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart. AF ablation: Empiric ablation (CFAE or linear ablation) is not permitted Ibutilide: Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization

Baseline characteristics by cohort

Measure	Patients With Atrial Fibrillation (AF) n=1 Participants Patients with AF and planned to undergo first catheter procedure
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: at 12 months

Population: Participant screen failed

Freedom from recurrent At/AF

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Participant screen failed

Number of drivers identified

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Participant screen failed

Size of drivers ablated

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 1 year

Population: Participant screen failed

Percent change of driver regions after ibutilide

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: post ablation inducibility of AF after 5 minutes of burst pacing

Population: Participant screen failed

AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 24 hours after the procedure is completed the time is calculated

Population: Participant screen failed

Total duration of RF ablation/fluoroscopy time/exposure procedure time

Outcome measures

Outcome data not reported

Adverse Events

Patients With Atrial Fibrillation (AF)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vivek Reddy

Icahn School of Medicine at Mount Sinai

Phone: (212) 241-7114

Email: vivek.reddy@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place