Ablation of Inappropriate Sinus Tachycardia (IST)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Inappropriate Sinus Tachycardia	Procedure: electrophysiology study and radiofrequency ablation	Not Applicable

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.

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	25 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input
Study Start Date :	April 2004
Estimated Primary Completion Date :	January 2020
Estimated Study Completion Date :	January 2020

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Single Group Assignment; electrophysiology study and radiofrequency ablation	Procedure: electrophysiology study and radiofrequency ablation; stimulation protocol searching for the neural inputs to the sinus node region and radiofrequency ablation of neural input to the heart

Outcome Measures

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Primary Outcome Measures :

1. 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. ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. 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).
2. 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.
3. Symptoms (or sinus rate) not explained by an alternative medical or electrophysiological diagnosis.
4. Symptoms refractory to treatment with beta-blocker medication, or beta-blockers contra-indicated or not tolerated

Exclusion Criteria:

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

United States, Oklahoma
University of Oklahoma Health Sciences Center	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Sub-Investigator: Karen Beckman, MD
Sub-Investigator: Sunny Po, MD

Sponsors and Collaborators

University of Oklahoma

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00584649 History of Changes
Other Study ID Numbers:	1364
First Posted:	January 2, 2008
Last Update Posted:	April 11, 2018
Last Verified:	April 2018

Keywords provided by University of Oklahoma:

Inappropriate Sinus Tachycardia; Inappropiate Tachycardia; Sinus Tachycardia; Palpitations; Fast Heart rate

Additional relevant MeSH terms:

Tachycardia; Tachycardia, Sinus; Arrhythmias, Cardiac; Heart Diseases	Cardiovascular Diseases; Pathologic Processes; Tachycardia, Supraventricular