HEAL-IST IDE Trial

Inappropriate Sinus Tachycardia Clinical Trial

Official title:

Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280093
• Other study ID #: CP-2021-04
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: June 2027

Study information

• Verified date: July 2023
• Source: AtriCure, Inc.
• Contact: Joseph Derr
• Phone: 1 (866) 349-2342
• Email: jderr[@]atricure.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inappropriate Sinus Tachycardia
• Tachycardia
• Tachycardia, Sinus

Intervention

Device:
• AtriCure ISOLATOR Synergy Surgical Ablation System
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System

Locations

Country	Name	City	State
Belgium	UZ Brussels	Brussels
Netherlands	Maastricht University Medical Center	Maastricht
United Kingdom	Northern General Hospital	Sheffield
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Saint Vincent's Medical Center	Bridgeport	Connecticut
United States	The Christ Hospital	Cincinnati	Ohio
United States	TriHealth, Inc.	Cincinnati	Ohio
United States	University of Florida	Gainesville	Florida
United States	Baptist Health	Miami	Florida
United States	Kansas City Cardiac Arrhythmia Research LLC	Overland Park	Kansas
United States	Sequoia Hospital	Redwood City	California
United States	Stanford University	Redwood City	California
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Intermountain Healthcare	Salt Lake City	Utah
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Swedish Medical Center	Seattle	Washington
United States	St. Joseph's Hospital / Baycare Health System	Tampa	Florida
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Netherlands,  United Kingdom, 

References & Publications (15)

Broglio KR, Connor JT, Berry SM. Not too big, not too small: a goldilocks approach to sample size selection. J Biopharm Stat. 2014;24(3):685-705. doi: 10.1080/10543406.2014.888569. — View Citation

C. De Asmundis et al, "Thoracoscopic Ablation of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome." Hands-On-Ablation, The Expert's Approach, Third Edition.

Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available. — View Citation

Cappato R, Castelvecchio S, Ricci C, Bianco E, Vitali-Serdoz L, Gnecchi-Ruscone T, Pittalis M, De Ambroggi L, Baruscotti M, Gaeta M, Furlanello F, Di Francesco D, Lupo PP. Clinical efficacy of ivabradine in patients with inappropriate sinus tachycardia: a prospective, randomized, placebo-controlled, double-blind, crossover evaluation. J Am Coll Cardiol. 2012 Oct 9;60(15):1323-9. doi: 10.1016/j.jacc.2012.06.031. Epub 2012 Sep 12. — View Citation

de Asmundis C, Chierchia GB, Lakkireddy D, Romeya A, Okum E, Gandhi G, Sieira J, Vloka M, Jones SD, Shah H, Winner M, Patel D, Whalen SP, Beaty EH, Kincaid EH, Lee A, Brodt C, Taylor BJ, Colombowala I, Romano M, Morady F, Stroker E, Overeinder I, Bala G, Van Meeteren J, Krauthammer Y, Koerber S, Shults C, Thomaides A, Badhwar N, Gopinathannair R, Shah A, Tummala R, Bello D, Hoff S, Almorad A, Frazier K, Brugada P, La Meir M. Sinus node sparing novel hybrid approach for treatment of inappropriate sinus tachycardia/postural sinus tachycardia: multicenter experience. J Interv Card Electrophysiol. 2022 Apr;63(3):531-544. doi: 10.1007/s10840-021-01044-5. Epub 2021 Aug 23. — View Citation

de Asmundis C, Chierchia GB, Sieira J, Stroker E, Umbrain V, Poelaert J, Brugada P, La Meir M. Sinus Node Sparing Novel Hybrid Approach for Treatment of Inappropriate Sinus Tachycardia/Postural Orthostatic Sinus Tachycardia With New Electrophysiological Finding. Am J Cardiol. 2019 Jul 15;124(2):224-232. doi: 10.1016/j.amjcard.2019.04.019. Epub 2019 Apr 23. — View Citation

Khiabani AJ, Greenberg JW, Hansalia VH, Schuessler RB, Melby SJ, Damiano RJ Jr. Late Outcomes of Surgical Ablation for Inappropriate Sinus Tachycardia. Ann Thorac Surg. 2019 Oct;108(4):1162-1168. doi: 10.1016/j.athoracsur.2019.03.103. Epub 2019 May 8. — View Citation

Kreisel D, Bailey M, Lindsay BD, Damiano RJ Jr. A minimally invasive surgical treatment for inappropriate sinus tachycardia. J Thorac Cardiovasc Surg. 2005 Aug;130(2):598-9. doi: 10.1016/j.jtcvs.2004.12.026. No abstract available. — View Citation

Lakkireddy D, Garg J, DeAsmundis C, LaMeier M, Romeya A, Vanmeetren J, Park P, Tummala R, Koerber S, Vasamreddy C, Shah A, Shivamurthy P, Frazier K, Awasthi Y, Chierchia GB, Atkins D, Bommana S, Di Biase L, Al-Ahmad A, Natale A, Gopinathannair R. Sinus Node Sparing Hybrid Thoracoscopic Ablation Outcomes in Patients with Inappropriate Sinus Tachycardia (SUSRUTA-IST) Registry. Heart Rhythm. 2022 Jan;19(1):30-38. doi: 10.1016/j.hrthm.2021.07.010. Epub 2021 Jul 30. — View Citation

Masumoto A, Takemoto M, Mito T, Tanaka A, Kawano Y, Kumeda H, Kang H, Matsuo A, Hida S, Okazaki T, Tayama KI, Yoshitake K, Kosuga K. Inappropriate Sinus Tachycardia Diagnosed and Treated as Depression Successfully Treated by Radiofrequency Catheter Ablation. Intern Med. 2017;56(5):523-526. doi: 10.2169/internalmedicine.56.7579. Epub 2017 Mar 1. — View Citation

Nwazue VC, Paranjape SY, Black BK, Biaggioni I, Diedrich A, Dupont WD, Robertson D, Raj SR. Postural tachycardia syndrome and inappropriate sinus tachycardia: role of autonomic modulation and sinus node automaticity. J Am Heart Assoc. 2014 Apr 10;3(2):e000700. doi: 10.1161/JAHA.113.000700. — View Citation

Olshansky B, Sullivan RM. Inappropriate sinus tachycardia. Europace. 2019 Feb 1;21(2):194-207. doi: 10.1093/europace/euy128. — View Citation

Pellegrini CN, Scheinman MM. Epidemiology and definition of inappropriate sinus tachycardia. J Interv Card Electrophysiol. 2016 Jun;46(1):29-32. doi: 10.1007/s10840-015-0039-8. Epub 2015 Aug 27. — View Citation

Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. No abstract available. — View Citation

Yasin OZ, Vaidya VR, Chacko SR, Asirvatham SJ. Inappropriate Sinus Tachycardia: Current Challenges and Future Directions. J Innov Card Rhythm Manag. 2018 Jul 15;9(7):3239-3243. doi: 10.19102/icrm.2018.090706. eCollection 2018 Jul. No abstract available. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	Freedom from IST at 12-months. Freedom from IST is defined as mean heart rate of = 90bpm or at least a 15% reduction in mean heart rate as compared to baseline, in the absence of new or higher dosage of previously failed medications.	12-months Post Procedure
Primary	Primary Safety Endpoint	Incidence of device or procedure-related major adverse events (MAEs) for subjects undergoing the hybrid sinus node sparing ablation procedure from the index procedure through 30-days post procedure	30-days Post Procedure
Secondary	6-Minute Walk Test	Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure	24-months Post Procedure
Secondary	Borg dyspnea score	Change in Borg dyspnea severity of breathlessness and fatigue score from baseline compared to 6-, 12- and 24-months post-procedure. Borg dyspnea score will be assessed at each of the 6-MWT.	24-months Post Procedure
Secondary	Self-Rating Anxiety Scale	Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS)	24-months Post Procedure
Secondary	IST symptom reduction	IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure	24-months Post Procedure
Secondary	QoL - SF-12	Change in QoL based on a Short Form Survey (SF-12) domain and component scores at baseline compared to 6-, 12- and 24-months post-procedure	24-months Post Procedure
Secondary	Mean heart rate	Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring	24-months Post Procedure
Secondary	Reduction in mean heart rate in the absence of rate control drugs	Freedom from IST or at least 15% reduction in mean heart rate at 12- and 24-months compared to baseline, in the absence of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs	24-months Post Procedure
Secondary	Reduction in mean heart rate regardless of rate control drugs	Freedom from IST or at least a 15% reduction in mean heart rate at 12- and 24-months compared to baseline, regardless of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs	24-months Post Procedure
Secondary	Device or procedure related Serious Adverse Events	Device or procedure related Serious Adverse Events (SAEs) through 12-months	12-months Post Procedure
Secondary	Improved heart rate variability - 7-day monitor	Improved heart rate variability for subjects using 7-day continuous monitoring	12-months Post Procedure
Secondary	Improved heart rate variability - Implantable loop recorder	Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs)	12-months Post Procedure
Secondary	Health Economics	Health Economics: ER visits and readmissions	24-months Post Procedure