HEAL-IST IDE 체험판
2026년 11월 3일 업데이트: AtriCure, Inc.
부적합한 동성 빈맥에 대한 하이브리드 심외막 및 심내막동 결절 보존 절제 요법
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.
연구 개요
연구 유형
중재적
등록 (실제)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Amsterdam, 네덜란드
- Amsterdam University Medical Center
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Maastricht, 네덜란드
- Maastricht University Medical Center
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Arkansas
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Jonesboro, Arkansas, 미국, 72401
- St. Bernard
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California
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Loma Linda, California, 미국, 92354
- Loma Linda University Health
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Redwood City, California, 미국, 94063
- Stanford University
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Redwood City, California, 미국, 94062
- Sequoia Hospital
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Connecticut
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Bridgeport, Connecticut, 미국, 06606
- Saint Vincent's Medical Center
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20010
- Medstar Washington Hospital Center
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Florida
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Gainesville, Florida, 미국, 32610
- University of Florida
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Miami, Florida, 미국, 33143
- Baptist Health
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Sarasota, Florida, 미국, 34239
- Sarasota Memorial Hospital
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Tampa, Florida, 미국, 33607
- St. Joseph's Hospital / Baycare Health System
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Georgia
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Savannah, Georgia, 미국, 31404
- Memorial Health University Medical Center
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Idaho
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Boise, Idaho, 미국, 83706
- Saint Alphonsus Regional Medical Center
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Kansas
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Overland Park, Kansas, 미국, 66211
- Kansas City Cardiac Arrhythmia Research LLC
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, 미국, 45219
- The Christ Hospital
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Cincinnati, Ohio, 미국, 45202
- TriHealth, Inc.
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Texas
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Austin, Texas, 미국, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Utah
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Salt Lake City, Utah, 미국, 84111
- Intermountain Healthcare
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Virginia
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Richmond, Virginia, 미국, 23219
- Virginia Commonwealth University
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Washington
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Seattle, Washington, 미국, 98122
- Swedish Medical Center
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Brussels, 벨기에
- UZ Brussels
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Sheffield, 영국, S5 7AU
- Northern General Hospital
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Milan, 이탈리아
- San Raffaele Hospital
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Warsaw, 폴란드
- Central Clinic Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Hybrid sinus node sparing ablation procedure
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System |
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Primary Effectiveness Endpoint
기간: 12-months Post Procedure
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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
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Primary Safety Endpoint
기간: 30-days Post Procedure
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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6-Minute Walk Test
기간: 24-months Post Procedure
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Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure |
24-months Post Procedure
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Borg dyspnea score
기간: 24-months Post Procedure
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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
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Self-Rating Anxiety Scale
기간: 24-months Post Procedure
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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
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IST symptom reduction
기간: 24-months Post Procedure
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IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure |
24-months Post Procedure
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QoL - SF-12
기간: 24-months Post Procedure
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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
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Mean heart rate
기간: 24-months Post Procedure
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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
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Reduction in mean heart rate in the absence of rate control drugs
기간: 24-months Post Procedure
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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
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Reduction in mean heart rate regardless of rate control drugs
기간: 24-months Post Procedure
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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
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Device or procedure related Serious Adverse Events
기간: 12-months Post Procedure
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Device or procedure related Serious Adverse Events (SAEs) through 12-months |
12-months Post Procedure
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Improved heart rate variability - 7-day monitor
기간: 12-months Post Procedure
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Improved heart rate variability for subjects using 7-day continuous monitoring |
12-months Post Procedure
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Improved heart rate variability - Implantable loop recorder
기간: 12-months Post Procedure
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Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs) |
12-months Post Procedure
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Health Economics
기간: 24-months Post Procedure
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Health Economics: ER visits and readmissions |
24-months Post Procedure
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute
- 수석 연구원: Mark La Meir, MD, Universitair Ziekenhuis Brussel
- 수석 연구원: Carlo de Asmundis, MD, Universitair Ziekenhuis Brussel
- 수석 연구원: Thomas Beaver, MD, University of Florida
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- Olshansky B, Sullivan RM. Inappropriate sinus tachycardia. Europace. 2019 Feb 1;21(2):194-207. doi: 10.1093/europace/euy128.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 5월 31일
기본 완료 (추정된)
2027년 2월 1일
연구 완료 (추정된)
2028년 2월 1일
연구 등록 날짜
최초 제출
2022년 3월 4일
QC 기준을 충족하는 최초 제출
2022년 3월 4일
처음 게시됨 (실제)
2022년 3월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 11월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 11월 3일
마지막으로 확인됨
2026년 11월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CP-2021-04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .