NCT00584558

Brief Summary

The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at the OU Medical Center.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 2, 2017

Completed
Last Updated

October 2, 2017

Status Verified

May 1, 2017

Enrollment Period

15.4 years

First QC Date

December 20, 2007

Results QC Date

March 14, 2017

Last Update Submit

May 3, 2017

Conditions

Arrhythmia

Keywords

ArrhythmiaCatheter Ablation

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Arrhythmia Recurrence

    Number and % patients with documented arrhythmias recurrences

    0-10 years

Secondary Outcomes (1)

  • Number of Patients With Complications From Catheter Ablation

    0-10 years

Study Arms (1)

1

Patients undergoing catheter ablation.

Procedure: Catheter Ablation

Interventions

Catheter AblationPROCEDURE

Catheter Ablation of arrhythmias

Also known as: All approved ablation catheters, Investigational ablation catheters
1

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing catheter ablation at the OU Medical Center

You may qualify if:

  • Undergoing catheter ablation at the OU Medical Center

You may not qualify if:

  • Prisoners
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Results Point of Contact

Title
Karen Beckman, MD
Organization
University of Oklahoma Health Sciences Center
karen-beckman@ouhsc.edu
405-271-9696

Study Officials

  • Karen Beckman, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 2, 2008

Study Start

February 1, 2001

Primary Completion

June 8, 2016

Study Completion

June 8, 2016

Last Updated

October 2, 2017

Results First Posted

October 2, 2017

Record last verified: 2017-05

Locations

US(1)