Hybrid ablation procedure for inappropriate sinus tachycardia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of a hybrid sinus node sparing ablation procedure for patients suffering from inappropriate sinus tachycardia (IST) who are intolerant or refractory to drug treatments. The study aims to provide a systematic clinical approach to a condition that significantly impacts the quality of life of otherwise healthy younger individuals. Participants will undergo the AtriCure ISOLATOR Synergy Surgical Ablation System intervention to assess its efficacy in alleviating symptoms associated with IST.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75 years at time of enrollment consent
2. Subject has a diagnosis of IST
3. 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
4. Subject is willing and able to provide written informed consent

Exclusion Criteria:

1. Subjects on whom cardiac surgery or single lung ventilation cannot be performed
2. Subjects with indication for or existing ICDs/Pacemakers
3. Presence of channelopathies
4. Previous cardio-thoracic surgery
5. Left Ventricular Ejection Fraction (LVEF) \< 50%
6. Body Mass Index (BMI) ≥ 35
7. Presence of supraventricular or ventricular tachycardia
8. Presence of Postural Orthostatic Sinus Tachycardia (POTS)
9. Presence of congenital heart disease
10. 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
11. Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders
12. Life expectancy \< 24 months
13. Pregnant or planning to become pregnant during trial
14. Subjects with substance abuse
15. Subjects with previous weight loss surgery
16. Subject is unwilling and/or unable to return for scheduled follow-up visits
17. 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
18. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and;
19. 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

Where it's running

• Loma Linda University Health
  Loma Linda, California, United States Recruiting
• Sequoia Hospital
  Redwood City, California, United States Recruiting
• Stanford University
  Redwood City, California, United States Recruiting
• Saint Vincent's Medical Center
  Bridgeport, Connecticut, United States Recruiting
• Medstar Washington Hospital Center
  Washington, District of Columbia, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Dhanunjaya Lakkireddy, MD — Kansas City Heart Rhythm Institute
• Study coordinator: Joseph Derr
• Email: jderr@atricure.com
• Phone: 1 (866) 349-2342

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for Inappropriate Sinus Tachycardia and Postural Tachycardia Syndrome treatments

  This study is collecting information on the safety and effectiveness of AtriCure devices used to treat people with Inappropriate Sinus Tachycardia or Postural Tachycardia Syndrome.

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• Preventing atrial fibrillation with surgical ablation and left atrial appendage clipping during heart surgery

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• Tracking nerve-freezing during limb amputation to learn about post-operative and phantom limb pain

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  Recruiting at 9 sites AtriCure, Inc. · Jacksonville, Florida and 8 other locations · NCT06908538

• Registry for tracking results of heart ablation procedures

  This study is tracking how well AtriCure devices work and their safety for patients who have had heart ablation procedures.

  Recruiting at 29 sites AtriCure, Inc. · Huntsville, Alabama and 28 other locations · NCT05111015

• Registry tracking outcomes of cryoanalgesia for post-operative pain management

  This study is tracking how well a new pain management technique using cryoablation of nerve blocks works for patients after surgery.

  Recruiting at 10 sites AtriCure, Inc. · Jacksonville, Florida and 10 other locations · NCT05110989

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.