HEAL-IST IDE Trial

NCT05280093 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CP-2021-04
• Study Type: interventional
• Target: 142
• Locations: 6 countries
• Sites: 27

Brief 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.

Conditions

Inappropriate Sinus Tachycardia

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (12)

• 6-Minute Walk Test

  24-months Post Procedure

• Borg dyspnea score

  24-months Post Procedure

• Self-Rating Anxiety Scale

  24-months Post Procedure

• IST symptom reduction

  24-months Post Procedure

• QoL - SF-12

  24-months Post Procedure

Study Arms (1)

Hybrid sinus node sparing ablation procedure

EXPERIMENTAL

Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System

Device: AtriCure ISOLATOR Synergy Surgical Ablation System

Interventions

AtriCure ISOLATOR Synergy Surgical Ablation System DEVICE

Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System

Hybrid sinus node sparing ablation procedure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (27)

St. Bernard

Jonesboro, Arkansas, 72401, United States

Location

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Sequoia Hospital

Redwood City, California, 94062, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

Saint Vincent's Medical Center

Bridgeport, Connecticut, 06606, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Baptist Health

Miami, Florida, 33143, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

St. Joseph's Hospital / Baycare Health System

Tampa, Florida, 33607, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Kansas City Cardiac Arrhythmia Research LLC

Overland Park, Kansas, 66211, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

TriHealth, Inc.

Cincinnati, Ohio, 45202, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Intermountain Healthcare

Salt Lake City, Utah, 84111, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

UZ Brussels

Brussels, Belgium

Location

San Raffaele Hospital

Milan, Italy

Location

Amsterdam University Medical Center

Amsterdam, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Central Clinic Hospital

Warsaw, Poland

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

Related Publications (15)

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

  PMID: 29931244 BACKGROUND

• 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.

  PMID: 26310298 BACKGROUND

• 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.

  PMID: 31077661 BACKGROUND

• 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.

  PMID: 31084999 BACKGROUND

• 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.

  PMID: 25980576 BACKGROUND

• 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.

  PMID: 24721800 BACKGROUND

• 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.

  PMID: 28250298 BACKGROUND

• 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.

  PMID: 32479576 BACKGROUND

• 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.

  PMID: 22981555 BACKGROUND

• 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.

  PMID: 16077449 BACKGROUND

• 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.

  PMID: 34424446 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34339847 BACKGROUND

• 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.

  PMID: 28506916 BACKGROUND

• 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.

  PMID: 24697532 BACKGROUND

Study Officials

• Dhanunjaya Lakkireddy, MD

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

• Mark La Meir, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Carlo de Asmundis, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Thomas Beaver, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 15, 2022
• Study Start: May 31, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (21); PL (1); BE (1); GB (1); IT (1); NL (2)