Ablation of Inappropriate Sinus Tachycardia (IST)
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ClinicalTrials.gov Identifier: NCT00584649 |
Recruitment Status
:
Recruiting
First Posted
: January 2, 2008
Last Update Posted
: April 11, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inappropriate Sinus Tachycardia | Procedure: electrophysiology study and radiofrequency ablation | Not Applicable |
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 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 |
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
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- 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. ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584649
Contact: Deborah J Lockwood, MD | 405-271 9696 | deborah-lockwood@ouhsc.edu | |
Contact: Kathy Drennan, RN, CCRP | 405-271 2299 | kathy-drennan@ouhsc.edu |
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 |
Principal Investigator: | Deborah J Lockwood, MD | University of Oklahoma HSC Assistant Professor Medicine/Cardiology |
Responsible Party: | University of Oklahoma |
ClinicalTrials.gov Identifier: | NCT00584649 History of Changes |
Other Study ID Numbers: |
1364 |
First Posted: | January 2, 2008 Key Record Dates |
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 |