Ablation of Inappropriate Sinus Tachycardia (IST)

Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input

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 Overview

• Status: Terminated
• Conditions: Inappropriate Sinus Tachycardia
• Intervention / Treatment: Procedure: electrophysiology study and radiofrequency 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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2004
• Primary Completion (Actual): July 7, 2020
• Study Completion (Actual): July 7, 2020

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 31, 2007
• First Posted (Estimated): January 2, 2008

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Inappropriate Sinus Tachycardia; Inappropriate Tachycardia; Sinus Tachycardia; Palpitations; Fast Heart rate
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia, Supraventricular; Tachycardia; Tachycardia, Sinus
• Other Study ID Numbers: 1364