HEAL-IST IDE Trial

Overview

About this study

The purpose of this study 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 inappropriate sinus tachycardia (IST).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Age ≥ 18 years and ≤ 75 years at time of enrollment consent.
Subject has a diagnosis of IST:
- Documentation of mean heart rate > 90bpm with 7-day monitor within 90 days of the Index Procedure; and
- Documentation of a resting heart rate of > 100bpm; and
- Documentation of presence of IST for at least 6-months; and
- Documentation of absence of other tachycardia; and
- Documentation of absence of secondary causes such as hormonal issues or systemic illness that might contribute to increased heart rate.
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:
- Allowed catheter ablations in the right atrium:
- One previous catheter ablation > 90 days prior to the Index Procedure for AVRT or CTI;
- One previous catheter ablation > 180 days prior to the Index Procedure for AVNRT.
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 result

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/25/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Ammar Killu, M.B.B.S.	Open for enrollment	Contact information: CVRU Heart Rhythm Services Research Team (507) 255-0774

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ammar Killu, M.B.B.S.

Open for enrollment

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

The ideal treatment of inappropriate sinus tachycardia (IST) and postural orthostatic tachycardia syndrome (POTS) still needs to be defined. Medical treatments yield suboptimal results. Endocardial catheter ablation of the sinus node (SN) may risk phrenic nerve damage and open-heart surgery may be accompanied by unjustified invasive risks. Read More on PubMed
Medical treatment of inappropriate sinus tachycardia (IST) remains suboptimal. Radiofrequency sinus node (RF-SN) ablation has poor success and higher complication rates. Read More on PubMed
Inappropriate sinus tachycardia (IST) is a rare clinical disorder characterized by an elevated resting heart rate and an exaggerated rate response to exercise or autonomic stress. Pharmacologic therapy and catheter ablation are considered first-line treatments for IST but can yield suboptimal relief of symptoms. The results of surgical ablation at our center were reviewed for patients with refractory IST. Read More on PubMed
The ideal treatment of Inappropriate Sinus Tachycardia (IST) and Postural Orthostatic Tachycardia Syndrome (POTS) still needs to be defined. Medical treatment yields suboptimal results, endocardial ablation of the sinus node (SN) may risk phrenic nerve damage and open heart surgery may be accompanied by unjustified invasive risks. We describe our first experience of 50 consecutive patients (41 females, 22.83 ± 3.91 years) having undergone a novel hybrid thoracoscopic ablation for drug resistant IST (n = 39, 78%) or POTS (n = 11, 22%). The SN was identified with the help of 3D mapping. Surgery was performed through 3 (5 mm) ports from the right side. A minimally invasive approach with a radio frequency bipolar clamp was utilized to a new target sparing the SN region, to isolate the superior and the inferior caval veins, and a crista terminalis line was made. All lines were interconnected. Normal SR was restored in all patients at the end of the procedure. All patients discontinued medication during the follow-up. After a blanking period of 6 months all patients presented stable SR. At a mean of 28.4 ± 1.2 months, normal SN ruction and chronotropic response to exercise was present. In the 11 patients initially diagnosed with POTS, no syncope occurred. During the follow-up, pericarditis was the most common complication (39 patients; 78%) with complete resolution in all cases. In conclusions the preliminary results of our first experience with a SN sparing novel hybrid ablation of IST/POTS, using surgical thoracoscopic video-assisted epicardial ablation combined with concomitant endocardial 3D mapping may prove an efficient and safe therapeutic option in patients with symptomatic drug resistant IST and POTS. Importantly, in our study all patients had a complete resolution of the symptoms and restored normal SN activity. Read More on PubMed
Inappropriate sinus tachycardia (IST) is a clinical syndrome, oftentimes debilitating, defined by fast sinus rates (>100 b.p.m. at rest or >90 b.p.m. on average over 24 h and not due to underlying causes) associated with symptoms that may include palpitations, as described in some guidelines and consensus documents. While heart rates may vary by patient, especially based upon gender and age, some individuals experience sinus tachycardia or persistent fast sinus rates with no symptoms; these individuals would not necessarily be considered to have the syndrome of IST. Various explanations for IST have been considered but a definitive common mechanism is not yet known; the true aetiology may be multifactorial. A thorough evaluation of secondary causes of tachycardia is required in the work-up of all cases and if found, must be treated before a diagnosis of IST can be made. Finally, effective treatments vary but can include ivabradine, beta-blockers, or calcium channel antagonists; ablation is seldom advised. Read More on PubMed
We experienced a man in his 20s with inappropriate sinus tachycardia (IST) initially diagnosed and treated as depression who was steadily treated with radiofrequency catheter ablation (RFCA) using an EnSite™ system. The patient has remained well without any symptoms or medications, including antidepressants, for two years since the RFCA. To avoid missing IST and treating it as an emotional problem and/or mental illness such as depression, physicians - including cardiologists - should be aware of these conditions when examining patients with multiple and incapacitating complaints including palpitations and general fatigue and/or tachycardia, especially characterized by an elevated resting heart rate or a disproportionate increase in the heart rate with minimal exertion. Read More on PubMed
Inappropriate sinus tachycardia (IST) is a clinical syndrome lacking formal diagnostic criteria. It is generally defined as an elevated resting heart rate (HR; >90-100 bpm) with an exaggerated response to physical or emotional stress and a clearly sinus mechanism. Clinical manifestations are broad from a complete lack of symptoms to incapacitating incessant tachycardia. Now understood to be relatively prevalent, it is observed to have a generally benign prognosis, though symptoms may persist for years. Whether IST is a single discrete entity or a heterogeneous condition with overlap to other syndromes such as postural orthostatic tachycardia syndrome remains a matter of debate. Read More on PubMed
Inappropriate sinus tachycardia (IST) and postural tachycardia syndrome (POTS) are 2 disorders characterized by sinus tachycardia. It is debated whether the pathophysiology of IST and POTS results from abnormal autonomic regulation or abnormal sinus node function. We hypothesized that intrinsic heart rate (IHR) after autonomic blockade would be increased in patients with IST but not POTS. Read More on PubMed
We present a Bayesian adaptive design for a confirmatory trial to select a trial's sample size based on accumulating data. During accrual, frequent sample size selection analyses are made and predictive probabilities are used to determine whether the current sample size is sufficient or whether continuing accrual would be futile. The algorithm explicitly accounts for complete follow-up of all patients before the primary analysis is conducted. We refer to this as a Goldilocks trial design, as it is constantly asking the question, "Is the sample size too big, too small, or just right?" We describe the adaptive sample size algorithm, describe how the design parameters should be chosen, and show examples for dichotomous and time-to-event endpoints. Read More on PubMed
The purpose of this study was to investigate the role of ivabradine in the treatment of symptomatic inappropriate sinus tachycardia using a double-blind, placebo-controlled, crossover design. Read More on PubMed

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