To Assess the Safety and Efficacy of the Atrial Shunt Implant System in the Treatment of Patients With Chronic Left Heart Failure

Official title

Evaluating the Safety and Efficacy of Atrial Shunt Implantation Systems for the Treatment of Patients With Chronic Left Heart Failure Prospective, Multicenter, Single-group Target Value Clinical Trials

Overview

This trial is a prospective, multicenter, single-group target-value clinical trial in which patients with chronic left heart failure are planned to be recruited. Using the atrial shunt implantation system developed and produced by Morningside (Nantong) Medical Device Co., Ltd., the atrial septum is used to implant the instruments in the atrial septum. to verify the safety and efficacy of the atrial shunt implant system for the treatment of patients with chronic left heart failure.

Detailed description

This trial will be carried out in a number of clinical trial institutions in China, and a total of 120 subjects are planned to be included, and all subjects are in progress The single group was registered and surgically treated with an atrial shunt implant system and within 7 days of surgery or at the time of discharge, 30 days after surgery Clinical follow-up was carried out at 3 months after surgery, 6 months after surgery, and 12 months after surgery, followed by data collection, evaluation and statistics Analysis and 12 months of phased clinical summary submitted registration application, on this basis, complete 2 years, 3 years of long-term follow-up.

Interventions

• Device Atrial shunt implant system
  Patients with chronic left heart failure who meet the conditions of the clinical trial undergo interventional surgery with the "Atrial Shunt Implant System"

Primary outcome measures

• The clinical treatment success rate was 12 months after operation [Time frame: Twelve months after surgery]

Secondary outcome measures (9)

• Instrument success rate [Time frame: Intraoperative]
• Surgical success rate [Time frame: Immediately after surgery]
• 6 minutes walking distance change [Time frame: Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery 30 days, 3 months, 6 months, 1 year, 2 years, 3 years after surgery]
• New York Cardiac Function Grading NYHA [Time frame: Preoperative screening ，30 days, 3 months, 6 months, 1 year, 2 years, 3 years after surgery]
• Kansas City Cardiomyopathy Quality of Life Scale KCCQ Changes [Time frame: Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery]
• NT-proBNP or BNP variation [Time frame: Preoperative screening ，Before discharge, 30 days after surgery, 3 months, 6 months, 1 year]
• Probability of postoperative echocardiographic changes [Time frame: During surgery, before discharge, 30 days after surgery, 3 months, 6 months, 1 year]
• Incidence of device-related serious adverse events [Time frame: 30 days after surgery]
• Serious adverse events and incidence of adverse events [Time frame: Intraoperative complications, 30 days before discharge, 3 months, 6 months, 1 year, 2 years, 3 years]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years;
• Consistently stable GDMT (Guidelines for Guiding Drugs) according to The Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018 Treatment) heart failure for patients with chronic left heart failure who are still symptomatic for at least 1 month;
• History of hospital admission to heart failure in the past 12 months, serum BNP or NT-proBNP liters" within 6 months High (BNP in sinus rhythm patients> 70 pg/ml, atrial fibrillation patients > 200 pg/ml, or sinus rhythm patients NT-proBNP"> 200 pg/ml, patients with atrial fibrillation >600 pg/ml);
• Cardiac catheterization measures resting mean lung capillary wedge pressure PCWP or left atrial pressure LAP≥15 mmHg,And the difference between the RAP order of pulmonary capillary wedge pressure PCWP and right atrial pressure is ≥ 5 mmHg；
• Cardiac Function Classification (NYHA) Grade II-IV;
• The patient or his/her guardian can understand the purpose of the study, voluntarily participate and sign a written informed consent form, which is acceptable Patients followed up； -

Exclusion criteria

• Primary organic valvular disease and severe coronary artery disease requiring revascularization that are currently indicated for surgical intervention Changes, heart-related diseases indicated for pacemaker implantation treatment;
• Pulmonary hypertension (pulmonary vascular resistance PVR>4WoodsUnits);
• History of myocardial infarction or heart treatment surgery within three months;
• Patients with infective endocarditis or ultrasound findings of thrombosis or vegetations in the heart;
• Anatomical abnormalities that make surgery unfinished or anatomically unsuitable for surgery;
• Life expectancy < 12 months;
• History of stroke, transient cerebral ischemia, deep vein thrombosis or pulmonary embolism in the past 6 months;
• Pregnant or lactating women, or persons with family planning in the next year;
• Subjects whose judgement of poor compliance and who were unable to complete the study as required; -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Atrial shunt implant system — Nantong

Publications

• Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, Va PMID 33501848
• Hao G, Wang X, Chen Z, Zhang L, Zhang Y, Wei B, Zheng C, Kang Y, Jiang L, Zhu Z, Zhang J, Wang Z, Gao R; China Hypertension Survey Investigators. Prevalence of heart failure and left ventricular dysfunction in China: the China Hypertension Survey, 2012-2015. Eur J Heart Fail. 2019 Nov;21(11):1329-1337. doi: 10.1002/ejhf.1629. PMID 31746111
• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Cli PMID 28461007
• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Gro PMID 34447992
• Zhang Y, Zhang J, Butler J, Yang X, Xie P, Guo D, Wei T, Yu J, Wu Z, Gao Y, Han X, Zhang X, Wen S, Anker SD, Filippatos G, Fonarow GC, Gan T, Zhang R; China-HF Investigators. Contemporary Epidemiology, Management, and Outcomes of Patients Hospitalized for Heart Failure in China: Results From the China Heart Failure (China-HF) Registry. J Card Fail. 2017 Dec;23(12):868-875. doi: 10.1016/j.cardfail. PMID 29029965
• Shah SJ, Borlaug BA, Kitzman DW, McCulloch AD, Blaxall BC, Agarwal R, Chirinos JA, Collins S, Deo RC, Gladwin MT, Granzier H, Hummel SL, Kass DA, Redfield MM, Sam F, Wang TJ, Desvigne-Nickens P, Adhikari BB. Research Priorities for Heart Failure With Preserved Ejection Fraction: National Heart, Lung, and Blood Institute Working Group Summary. Circulation. 2020 Mar 24;141(12):1001-1026. doi: 10.116 PMID 32202936
• Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbely A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure PMID 17428822
• Sondergaard L, Reddy V, Kaye D, Malek F, Walton A, Mates M, Franzen O, Neuzil P, Ihlemann N, Gustafsson F. Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure. Eur J Heart Fail. 2014 Jul;16(7):796-801. doi: 10.1002/ejhf.111. Epub 2014 Jun 24. PMID 24961390

Identifiers

NCT: NCT05486000 · IN-ATRIAL SEPTAL-2022-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗