Ablation of Inappropriate Sinus Tachycardia - Full Text View

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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input

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)

Arms	Assigned Interventions
Single Group Assignment electrophysiology study and radiofrequency ablation	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

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00584649 History of Changes
Other Study ID Numbers:	1364
Study First Received:	December 20, 2007
Last Updated:	February 18, 2016
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:


Tachycardia Tachycardia, Sinus Arrhythmias, Cardiac Heart Diseases	Cardiovascular Diseases Pathologic Processes Tachycardia, Supraventricular

ClinicalTrials.gov processed this record on September 23, 2016

Ablation of Inappropriate Sinus Tachycardia (IST)