Oklahoma City, Oklahoma 73104


Purpose:

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 summary:

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.


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.


Study is Available At:


Original ID:

1364


NCT ID:

NCT00584649


Secondary ID:


Study Acronym:

IST


Brief Title:

Ablation of Inappropriate Sinus Tachycardia


Official Title:

Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Oklahoma


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Deborah J Lockwood, MD
Principal Investigator
University of Oklahoma HSC Assistant Professor Medicine/Cardiology
Primary Contact:Deborah J Lockwood, MD
405-271 9696
deborah-lockwood@ouhsc.edu
Backup Contact:Kathy Drennan, RN, CCRP
405-271 2299
kathy-drennan@ouhsc.edu

Study Dates

Start Date:April 2004
Completion Date:January 2020
Completion Type:Anticipated
Primary Completion Date:January 2020
Primary Completion Type:Anticipated
Verification Date:April 2018
Last Changed Date:April 10, 2018
First Received Date:December 20, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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.
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:electrophysiology study and radiofrequency ablatio
Description:stimulation protocol searching for the neural inputs to the sinus node region and radiofrequency ablation of neural input to the heart
Arm Name:Single Group Assignment

Study Arms

Study Arm Type:Other
Arm Name:Single Group Assignment
Description:electrophysiology study and radiofrequency ablation

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Oklahoma

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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