Ablation of Inappropriate Sinus Tachycardia

Not Applicable

Terminated

• Conditions: Inappropriate Sinus Tachycardia
• Interventions: Procedure: electrophysiology study and radiofrequency ablation

• Registration Number: NCT00584649
• Lead Sponsor: University of Oklahoma

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.

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 Timeline

• Study Start: 2004-04
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-02
• Primary Completion: 2020-07-07
• Study Completion: 2020-07-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Group Assignment	electrophysiology study and radiofrequency ablation	electrophysiology study and radiofrequency ablation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States