Trial Outcomes & Findings for Long-Term Follow-Up of Patients Undergoing Catheter Ablation (NCT NCT00584558)

Results Overview

Number and % patients with documented arrhythmias recurrences

Recruitment status

COMPLETED

Target enrollment

2420 participants

Primary outcome timeframe

0-10 years

Results posted on

2017-10-02

Participant milestones
Measure	1-Catheter Ablation There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.
Overall Study STARTED	2420
Overall Study COMPLETED	2420
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Long-Term Follow-Up of Patients Undergoing Catheter Ablation

Baseline characteristics by cohort
Measure	Observational Arm n=2420 Participants All patients studied
Age, Categorical <=18 years	678 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1306 Participants n=5 Participants
Age, Categorical >=65 years	436 Participants n=5 Participants
Sex: Female, Male Female	992 Participants n=5 Participants
Sex: Female, Male Male	1428 Participants n=5 Participants
Region of Enrollment United States	2420 participants n=5 Participants

Timeframe: 0-10 years

Population: Patients who underwent ablation of arrhythmias

Number and % patients with documented arrhythmias recurrences

Outcome measures
Measure	1-Catheter Ablation n=2420 Participants There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.
Number of Patients With Arrhythmia Recurrence	100 Participants

Timeframe: 0-10 years

Number and % of patients with major adverse events as recorded in the medical record

Outcome measures
Measure	1-Catheter Ablation n=2430 Participants There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.
Number of Patients With Complications From Catheter Ablation	72 Participants

Serious events: 72 serious events

Other events: 24 other events

Deaths: 6 deaths

Serious adverse events
Measure	Observational Arm n=2420 participants at risk Patients undergoing catheter ablation. Catheter Ablation: Catheter Ablation of arrhythmias
Cardiac disorders Cardiac Tamponade	3.0% 72/2420 • Number of events 72

Other adverse events
Measure	Observational Arm n=2420 participants at risk Patients undergoing catheter ablation. Catheter Ablation: Catheter Ablation of arrhythmias
Vascular disorders IVC thrombus	0.99% 24/2420 • Number of events 24

University of Oklahoma Health Sciences Center

Phone: 405-271-9696