ArrhythmiaNCT00584558

Long-Term Follow-Up of Patients Undergoing Catheter Ablation

An observational study of Arrhythmia, run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 1 year to 100 years
Conditions the study is for: Arrhythmia
What is being tested?: Catheter Ablation
Type of treatment: Surgery or procedure
How many people: 2,420 participants
Where: 1 siteUnited States
Study dates: Feb 2001to 8 Jun 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 100 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients undergoing catheter ablation at the OU Medical Center

Who may be able to join

Undergoing catheter ablation at the OU Medical Center

Who cannot join

Prisoners
Refusal to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

OU Medical Center
Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: Long-Term Follow-Up of Catheter Ablation

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

Read the detailed description

The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at this institution, including recurrence of the ablated arrhythmia and any late complications.

Conditions: Arrhythmia
Being tested: Catheter Ablation
Keywords: Arrhythmia, Catheter Ablation
Medical subject headings: Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Catheter AblationProcedure or surgery
Also called All approved ablation catheters, Investigational ablation catheters
Catheter Ablation of arrhythmias

Study groups in NCT00584558
Study group	Role	What they receive
1		Patients undergoing catheter ablation. Receives: Procedure: Catheter Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Arrhythmia Recurrence
Number and % patients with documented arrhythmias recurrences
Measured: 0-10 years

Secondary outcomes (1)

Number of Patients With Complications From Catheter Ablation
Number and % of patients with major adverse events as recorded in the medical record
Measured: 0-10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 20018 Jun 2016

First posted2 Jan 2008 (estimated)
Study startFeb 2001
Primary completion8 Jun 2016
Study completion8 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ArrhythmiaStudies of the same condition, open and under way.
More trials run by University of OklahomaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00584558
Sponsor's protocol ID: 1239
Status last verified: May 2017
First submitted: 20 Dec 2007
Last updated: 2 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Ventricular Arrhythmia

All Arrhythmia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-Term Follow-Up of Catheter Ablation
ClinicalTrials.gov ID: NCT00584558
Acronym / sponsor ID: 1239
Conditions: Arrhythmia
Keywords: Arrhythmia, Catheter Ablation
Study type: Observational
Recruitment status: Completed
Enrolment: 2,420 participants (actual)
Lead sponsor: University of OklahomaUniversity, hospital or other
Study start: Feb 2001
Primary completion: 8 Jun 2016 (actual)
Study completion: 8 Jun 2016 (actual)
First posted: 2 Jan 2008 (estimated)
Results: Posted 2 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at this institution, including recurrence of the ablated arrhythmia and any late complications.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	Procedure: Catheter AblationPatients undergoing catheter ablation.

Who may qualify

Ages: 1 year to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients undergoing catheter ablation at the OU Medical Center

Key inclusion criteria (1 listed)

Undergoing catheter ablation at the OU Medical Center

Key exclusion criteria (2 listed)

Prisoners
Refusal to participate

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Catheter AblationAlso: All approved ablation catheters, Investigational ablation cathetersCatheter Ablation of arrhythmias	Procedure or surgery	1

Primary outcome

Number of Patients With Arrhythmia Recurrence
Time frame: 0-10 years
Number and % patients with documented arrhythmias recurrences

1 secondary outcome

Number of Patients With Complications From Catheter Ablation
Time frame: 0-10 years

Results and safety

Results posted to the registry on 2 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1-Catheter Ablation	2,420	2,420

Primary outcome: Number of Patients With Arrhythmia Recurrence

Time frame: 0-10 years. Count of participants. Unit: Participants

Measure	1-Catheter Ablation n = 2420
Value	100

Population analysed: Patients who underwent ablation of arrhythmias

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Arm	72 of 2,420 (3%)	24 of 2,420 (1%)	6 of 2,420

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arrhythmia

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen Beckman, MD principal investigator

University of Oklahoma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arrhythmia, run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Arrhythmia Recurrence (time frame: 0-10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00584558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.