Ablation of Inappropriate Sinus Tachycardia - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

July 7, 2009

Start Date ^ICMJE

April 2004

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Improvement in:symptoms(palpitations);quality of life;resting heart rate;mean 24 hour heart rate;heart rate variability; [ Time Frame: Clinical efficacy is established if the improvement is maintained after 6months to a year. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00584649 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

duration of symptom limited Bruce protocol exercise treadmill test;duration of exercise test required to increase rate by 20%. [ Time Frame: 6 months to 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Ablation of Inappropriate Sinus Tachycardia

Official Title ^ICMJE

Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input.

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 tachycarida.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Inappropriate Sinus Tachycardia

Intervention ^ICMJE

Procedure: electrophysiology study and radiofrequency ablation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Deborah J Lockwood, MD	405-271 9696	deborah-lockwood@ouhsc.edu
Contact: Kathy Drennan, RN, CCRP	405-271 2299	kathy-drennan@ouhsc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00584649

Responsible Party

Dr. Deborah Lockwood, Oklahoma University Health Sciences Center

Study ID Numbers ^ICMJE

11468

Study Sponsor ^ICMJE

University of Oklahoma

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Deborah J Lockwood, MD

University of Oklahoma HSC Assistant Professor Medicine/Cardiology

Information Provided By

University of Oklahoma

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP