Ablation of Inappropriate Sinus Tachycardia

NCT00584649 | Terminated

• 1 other identifier: 1364
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Inappropriate Sinus Tachycardia

Keywords

Inappropriate Sinus Tachycardia; Inappropriate Tachycardia; Sinus Tachycardia; Palpitations; Fast Heart rate

Outcome Measures

Primary Outcomes (1)

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

  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%.

  6 months to 1 year

Study Arms (1)

Single Group Assignment

OTHER

electrophysiology study and radiofrequency ablation

Procedure: electrophysiology study and radiofrequency ablation

Interventions

electrophysiology study and radiofrequency ablation PROCEDURE

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

Single Group Assignment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Tachycardia, Sinus; Tachycardia

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Tachycardia, Supraventricular; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Deborah J Lockwood, MD

  University of Oklahoma HSC Assistant Professor Medicine/Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 2, 2008
• Study Start: April 1, 2004
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

US (1)