Inappropriate Sinus TachycardiaISTNCT00584649
Ablation of Inappropriate Sinus Tachycardia
A study testing electrophysiology study and radiofrequency ablation in people with Inappropriate Sinus Tachycardia, run by University of Oklahoma at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inappropriate Sinus Tachycardia
- What is being tested?
- electrophysiology study and radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to 7 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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.
- Conditions
- Inappropriate Sinus Tachycardia
- Being tested
- electrophysiology study and radiofrequency ablation
- Keywords
- Inappropriate Sinus Tachycardia, Inappropriate Tachycardia, Sinus Tachycardia, Palpitations, Fast Heart rate
- Medical subject headings
- Tachycardia, Sinus, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrophysiology study and radiofrequency ablationProcedure or surgery
stimulation protocol searching for the neural inputs to the sinus node region and radiofrequency ablation of neural input to the heart
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Other | electrophysiology study and radiofrequency ablation Receives: Procedure: electrophysiology study and radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in:symptoms(palpitations);quality of life;resting heart rate;mean 24 hour heart rate;heart rate variability;
Measured: Clinical efficacy is established if the improvement is maintained after 6months to a year.
Secondary outcomes (1)
duration of symptom limited Bruce protocol exercise treadmill test;duration of exercise test required to increase rate by 20%.
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startApr 2004
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Why it stopped: Study closed out when PI left the university.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate Sinus TachycardiaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah J Lockwood, MD, Principal investigator, University of Oklahoma HSC Assistant Professor Medicine/Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584649
- Sponsor's protocol ID
- 1364
- Acronym
- IST
- Status last verified
- Mar 2024
- First submitted
- 20 Dec 2007
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input
- ClinicalTrials.gov ID
- NCT00584649
- Acronym / sponsor ID
- IST / 1364
- Conditions
- Inappropriate Sinus Tachycardia
- Keywords
- Inappropriate Sinus Tachycardia, Inappropriate Tachycardia, Sinus Tachycardia, Palpitations, Fast Heart rate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed out when PI left the university.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Apr 2004 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Other | Procedure: electrophysiology study and radiofrequency ablationelectrophysiology study and radiofrequency ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrophysiology study and radiofrequency ablationstimulation protocol searching for the neural inputs to the sinus node region and radiofrequency ablation of neural input to the heart | Procedure or surgery | Single Group Assignment |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Study closed out when PI left the university.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah J Lockwood, MD principal investigator
University of Oklahoma HSC Assistant Professor Medicine/Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrophysiology study and radiofrequency ablation in people with Inappropriate Sinus Tachycardia, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed out when PI left the university.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.