HEAL-IST
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StatusAccepting Candidates
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Age18 Years - 75 Years
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SexesAll
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Healthy VolunteersNo
Objective
Inappropriate Sinus Tachycardia (IST) is a prevalent and debilitating condition in otherwise healthy younger patients, resulting in significant loss of quality of life, lacking effective treatment options or systematic clinical evidence to support a therapy. The primary objective of this clinical trial is to evaluate the safety and effectiveness of a hybrid sinus node sparing ablation procedure for the treatment of symptomatic drug refractory or drug intolerant IST.
Details
Full study title | Hybrid Epicardial and Endocardial Sinus-Node SpAring AbLation Therapy for Inappropriate Sinus Tachycardia |
Protocol number | OCR42214 |
ClinicalTrials.gov ID | NCT05280093 |
Phase | N/A |
Eligibility
Inclusion Criteria:
Age � 18 years and � 75 years at time of enrollment consent
Subject has a diagnosis of IST
Documentation of refractoriness (intolerance or failure) of a drug (e.g., rate control drugs such as beta-blockers/calcium channel blockers, ivabradine), and/or AADs
Subject is willing and able to provide written informed consent
Exclusion Criteria:
Subjects on whom cardiac surgery or single lung ventilation cannot be performed
Subjects with indication for or existing ICDs/Pacemakers
Presence of channelopathies
Previous cardio-thoracic surgery
Left Ventricular Ejection Fraction (LVEF) < 50%
Body Mass Index (BMI) � 35
Presence of supraventricular or ventricular tachycardia
Presence of Postural Orthostatic Sinus Tachycardia (POTS)
Presence of congenital heart disease
History suggestive of secondary cause of tachycardia such as pheochromocytoma,
anemia, thyrotoxicosis, chronic fever of unknown origin, COPD, long-term
bronchodilators use, severe asthma or carcinoid syndrome
- Subjects who have had a previous catheter ablation in the right atrium for IST or
other disorders
Life expectancy < 24 months
Pregnant or planning to become pregnant during trial
Subjects with substance abuse
Subjects with previous weight loss surgery
Subject is unwilling and/or unable to return for scheduled follow-up visits
Current participation in another clinical investigation of a medical device or a
drug, or recent participation in such a trial that may interfere with trial results
- Not competent to legally represent him or herself (e.g., requires a guardian or
caretaker as a legal representative) and;
- Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the clinical investigation or to comply with
follow-up requirements, or impact the scientific soundness of the clinical
investigation results
Lead researcher
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.