search
Back to results

Ablation of Inappropriate Sinus Tachycardia (IST)

Primary Purpose

Inappropriate Sinus Tachycardia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electrophysiology study and radiofrequency ablation
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inappropriate Sinus Tachycardia focused on measuring Inappropriate Sinus Tachycardia, Inappropriate Tachycardia, Sinus Tachycardia, Palpitations, Fast Heart rate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Group Assignment

Arm Description

electrophysiology study and radiofrequency ablation

Outcomes

Primary Outcome Measures

Improvement in:symptoms(palpitations);quality of life;resting heart rate;mean 24 hour heart rate;heart rate variability;

Secondary Outcome Measures

duration of symptom limited Bruce protocol exercise treadmill test;duration of exercise test required to increase rate by 20%.

Full Information

First Posted
December 20, 2007
Last Updated
April 21, 2020
Sponsor
University of Oklahoma
search

1. Study Identification

Unique Protocol Identification Number
NCT00584649
Brief Title
Ablation of Inappropriate Sinus Tachycardia
Acronym
IST
Official Title
Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inappropriate Sinus Tachycardia
Keywords
Inappropriate Sinus Tachycardia, Inappropriate Tachycardia, Sinus Tachycardia, Palpitations, Fast Heart rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Group Assignment
Arm Type
Other
Arm Description
electrophysiology study and radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
electrophysiology study and radiofrequency ablation
Intervention Description
stimulation protocol searching for the neural inputs to the sinus node region and radiofrequency ablation of neural input to the heart
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah J Lockwood, MD
Organizational Affiliation
University of Oklahoma HSC Assistant Professor Medicine/Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ablation of Inappropriate Sinus Tachycardia

We'll reach out to this number within 24 hrs