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Inappropriate Sinus Tachycardia | Ablation of Inappropriate Sinus Tachycardia

Inappropriate Sinus Tachycardia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Inappropriate Sinus Tachycardia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure: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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Single Group Assignmentelectrophysiology study and radiofrequency ablation

Study Status

Recruiting

Start Date: April 2004

Completed Date: January 2020

Phase: N/A

Type: Interventional

Design:

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

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

Study sponsors, principal investigator, and references

Principal Investigator: Deborah J Lockwood, MD

Lead Sponsor: University of Oklahoma

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00584649

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