Ablation of Inappropriate Sinus Tachycardia - Full Text View

Sponsor:	University of Oklahoma
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00584649

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.

Condition	Intervention
Inappropriate Sinus Tachycardia	Procedure: electrophysiology study and radiofrequency ablation

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input.

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	April 2004
Estimated Study Completion Date:	January 2020
Estimated Primary Completion Date:	January 2020 (Final data collection date for primary outcome measure)

Intervention Details:

stimulation protocol searching for the neural inputs to the sinus node region and radiofrequency ablation of neural input to the heart

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584649

Contacts

Contact: Deborah J Lockwood, MD	405-271 9696	deborah-lockwood@ouhsc.edu
Contact: Kathy Drennan, RN, CCRP	405-271 2299	kathy-drennan@ouhsc.edu

Locations

United States, Oklahoma
University of Oklahoma Health Sciences Center	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Sub-Investigator: Karen Beckman, MD
Sub-Investigator: Sunny Po, MD

Sponsors and Collaborators

University of Oklahoma

Investigators

Principal Investigator:

Deborah J Lockwood, MD

University of Oklahoma HSC Assistant Professor Medicine/Cardiology

More Information

No publications provided

Responsible Party:	Oklahoma University Health Sciences Center ( Dr. Deborah Lockwood )
Study ID Numbers:	11468
Study First Received:	December 20, 2007
Last Updated:	January 12, 2010
ClinicalTrials.gov Identifier:	NCT00584649 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Oklahoma:

Inappropriate Sinus Tachycardia
Inappropiate Tachycardia
Sinus Tachycardia
Palpitations
Fast Heart rate

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia
Tachycardia, Sinus

Cardiovascular Diseases
Tachycardia, Supraventricular
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010