Ablation of Inappropriate Sinus Tachycardia

Inappropriate Sinus Tachycardia Clinical Trial

— IST  

Official title:

Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00584649
• Other study ID #: 1364
• Status: Terminated
• Phase: N/A
• Start date: April 2004
• Est. completion date: July 7, 2020

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inappropriate Sinus Tachycardia
• Tachycardia
• Tachycardia, Sinus

Intervention

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

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	duration of symptom limited Bruce protocol exercise treadmill test;duration of exercise test required to increase rate by 20%.		6 months to 1 year