Ablation of Inappropriate Sinus Tachycardia | NCT00584649

Studies
Ablation of Inappropriate Sinus Tachycardia

NCT00584649

Sponsor

University of Oklahoma

Status

Terminated

Last Update Posted

Apr 1, 2024Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Inappropriate Sinus Tachycardia

Interventions

electrophysiology study and radiofrequency ablation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study closed out when PI left the university.

Expanded Access Info

Start Date

Apr 2004Actual

Primary Completion Date

Jul 7, 2020Actual

Completion Date

Jul 7, 2020Actual

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 31, 2007

First Posted Date

Jan 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2024

Last Update Posted Date

Apr 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hypothesis- Radiofrequency ablation, targeting the sympathetic input of the sinus node identified by 20Hz stimulation at the junction of the superior vena cava and the right atrium, will effectively reduce sinus rate acutely and will reduce palpitations due to inappropriate sinus tachycardia without the need for pacemaker implantation due to sinus node dysfunction post ablation.

Detailed Description

Inappropriate sinus tachycardia syndrome describes a condition in which a patient's heart rate is intermittently (or persistently) higher than expected for the physiological circumstances, with ECG appearance indistinguishable from normal sinus rhythm, after the exclusion of medical conditions causing sinus tachycardia.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Group Assignment	Other	electrophysiology study and radiofrequency ablation	Procedure: electrophysiology study and radiofrequency ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electrophysiology study and radiofrequency ablation	Procedure	stimulation protocol searching for the neural inputs to the sinus node region and radiofrequency ablation of neural input to the heart

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in:symptoms(palpitations);quality of life;resting heart rate;mean 24 hour heart rate;heart rate variability;		Clinical efficacy is established if the improvement is maintained after 6months to a year.

Secondary Outcomes

Measure	Description	Time Frame
duration of symptom limited Bruce protocol exercise treadmill test;duration of exercise test required to increase rate by 20%.		6 months to 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between the ages of 18 and 80 years old, who are scheduled for an ablation procedure for suspected inappropriate sinus tachycardia, with symptomatic palpitations during periods where documented electrogram recordings suggest sinus tachycardia (holter, event recorder, or 12 lead ECG).
Sinus rate greater than 100 bpm with minimal physiologic challenge, or mean sinus rate during 24 hour holter more than 95bpm, or daytime resting heart rate more than 95bpm.
Symptoms (or sinus rate) not explained by an alternative medical or electrophysiological diagnosis.
Symptoms refractory to treatment with beta-blocker medication, or beta-blockers contra-indicated or not tolerated

Exclusion Criteria:

Children under 18 years of age (due to greater risk from exposure to X rays).
Any medical condition significantly increasing the risk of extending the ablation procedure or of X ray exposure, including pregnancy.
Significant orthostatic hypotension (due to need for rapid chronotropic response to fall in blood pressure)
An alternative cause for sinus tachycardia identified (e.g. hyperthyroidism or pheochromocytoma).
Inability or unwillingness to provide informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deborah J Lockwood, MD	University of Oklahoma HSC Assistant Professor Medicine/Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oklahoma Health Sciences Center		Oklahoma City	Oklahoma	73104	United States

Condition Browse Module

MeSH Terms

ID	Term
D013616	Tachycardia, Sinus
D013610	Tachycardia

Ancestor Terms

ID	Term
D013617	Tachycardia, Supraventricular
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided