Left Heart FailureNCT05486000
To Assess the Safety and Efficacy of the Atrial Shunt Implant System in the Treatment of Patients With Chronic Left Heart Failure
A study testing Atrial shunt implant system in people with Left Heart Failure, run by Morningside (Nantong) Medical Co.,Ltd at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Left Heart Failure
- What is being tested?
- Atrial shunt implant system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Aug 2022to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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； -
Who cannot join
- 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;
Show all 9Show fewer
- 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; -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Atrial shunt implant system
Nantong, Jiangsu, 210046
Yuchen liang, +8613774401524, ycliang@siriusmed.cn
About this study
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
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.
Read the 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.
- Conditions
- Left Heart Failure
- Being tested
- Atrial shunt implant system
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial shunt implant systemDevice
Patients with chronic left heart failure who meet the conditions of the clinical trial undergo interventional surgery with the "Atrial Shunt Implant System"
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | This group contains patients with chronic left heart failure who are undergoing intervention in the atrial shunt implant system Receives: Device: Atrial shunt implant system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical treatment success rate was 12 months after operation
Death and heart failure-related rehospitalization were avoided 12 months after surgery
Measured: Twelve months after surgery
Secondary outcomes (9)
Instrument success rate
The diverter was successfully implanted, the morphology was normal, and the conveyor system was successfully withdrawn
Measured: Intraoperative
Surgical success rate
On the basis of the success of the instrument, ultrasound is seen in simple left-to-right shunting immediately after surgery
Measured: Immediately after surgery
6 minutes walking distance change
The participants were assessed at the appropriate follow-up site
Measured: 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
New York Cardiac Function Grading NYHA is divided into four levels, which are determined according to the clinical presentation of the patient, and the higher the level, the more severe the symptoms of heart failure
Measured: 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
Kansas City Cardiomyopathy Quality of Life Scale KCCQ Changes consisted of a total of 23 items with a score between 0-100, with higher scores indicating less adverse effects of heart failure on a patient's quality of life
Measured: Preoperative screening ，30 days, 3 months, 6 months, 1 year after surgery
NT-proBNP or BNP variation
Corresponding follow-up sites are obtained by laboratory blood tests
Measured: Preoperative screening ，Before discharge, 30 days after surgery, 3 months, 6 months, 1 year
Probability of postoperative echocardiographic changes
Obtained through instrumentation inspection
Measured: During surgery, before discharge, 30 days after surgery, 3 months, 6 months, 1 year
Incidence of device-related serious adverse events
Serious adverse events related to the instrument that occur after the implantation of the instrument, such as the shedding of the instrument, embolism, causing damage to the mitral or tricuspid valve, causing severe arrhythmias, infectious endocarditis, any need to re-operate the instrument to remove the instrument, etc
Measured: 30 days after surgery
Serious adverse events and incidence of adverse events
Events that occur during clinical trials that result in death or serious deterioration of health status, as well as the probability of adverse medical events that occur after a subject is treated with a trial product
Measured: Intraoperative complications, 30 days before discharge, 3 months, 6 months, 1 year, 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Left Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morningside (Nantong) Medical Co.,Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Cardiovascular Hospital, Xiamen University
- Responsible party
- Sponsor
- Investigators
- yan wang, dean, Principal investigator, Xiamen Cardiovascular Hospital, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486000
- Sponsor's protocol ID
- IN-ATRIAL SEPTAL-2022-01
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.
PubMed 33501848Hao 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.
PubMed 31746111Yancy 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 Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017 Aug 8;70(6):776-803. doi: 10.1016/j.jacc.2017.04.025. Epub 2017 Apr 28. No abstract available.
PubMed 28461007McDonagh 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 Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992Zhang 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.2017.09.014. Epub 2017 Oct 10.
PubMed 29029965Shah 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: 10.1161/CIRCULATIONAHA.119.041886. Epub 2020 Mar 23.
PubMed 32202936Paulus 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 and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007 Oct;28(20):2539-50. doi: 10.1093/eurheartj/ehm037. Epub 2007 Apr 11.
PubMed 17428822Sondergaard 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.
PubMed 24961390Malek F, Neuzil P, Gustafsson F, Kaye DM, Walton A, Mates M, Sondergaard L, Ihlemann N, Mariani JA, Reddy V. Clinical outcome of transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel implant. Int J Cardiol. 2015;187:227-8. doi: 10.1016/j.ijcard.2015.03.198. Epub 2015 Mar 18. No abstract available.
PubMed 25841123Hasenfuss G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016 Mar 26;387(10025):1298-304. doi: 10.1016/S0140-6736(16)00704-2.
PubMed 27025436Kaye DM, Hasenfuss G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Dec;9(12):e003662. doi: 10.1161/CIRCHEARTFAILURE.116.003662.
PubMed 27852653Shah SJ, Feldman T, Ricciardi MJ, Kahwash R, Lilly S, Litwin S, Nielsen CD, van der Harst P, Hoendermis E, Penicka M, Bartunek J, Fail PS, Kaye DM, Walton A, Petrie MC, Walker N, Basuray A, Yakubov S, Hummel SL, Chetcuti S, Forde-McLean R, Herrmann HC, Burkhoff D, Massaro JM, Cleland JGF, Mauri L. One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial: A Randomized Clinical Trial. JAMA Cardiol. 2018 Oct 1;3(10):968-977. doi: 10.1001/jamacardio.2018.2936.
PubMed 30167646Amat-Santos IJ, Bergeron S, Bernier M, Allende R, Barbosa Ribeiro H, Urena M, Pibarot P, Verheye S, Keren G, Yaacoby M, Nitzan Y, Abraham WT, Rodes-Cabau J. Left atrial decompression through unidirectional left-to-right interatrial shunt for the treatment of left heart failure: first-in-man experience with the V-Wave device. EuroIntervention. 2015 Jan;10(9):1127-31. doi: 10.4244/EIJY14M05_07.
PubMed 24832489Del Trigo M, Bergeron S, Bernier M, Amat-Santos IJ, Puri R, Campelo-Parada F, Altisent OA, Regueiro A, Eigler N, Rozenfeld E, Pibarot P, Abraham WT, Rodes-Cabau J. Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study. Lancet. 2016 Mar 26;387(10025):1290-7. doi: 10.1016/S0140-6736(16)00585-7.
PubMed 27025435Rodes-Cabau J, Bernier M, Amat-Santos IJ, Ben Gal T, Nombela-Franco L, Garcia Del Blanco B, Kerner A, Bergeron S, Del Trigo M, Pibarot P, Shkurovich S, Eigler N, Abraham WT. Interatrial Shunting for Heart Failure: Early and Late Results From the First-in-Human Experience With the V-Wave System. JACC Cardiovasc Interv. 2018 Nov 26;11(22):2300-2310. doi: 10.1016/j.jcin.2018.07.001. Epub 2018 Nov 1.
PubMed 30391390
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05486000
- Acronym / sponsor ID
- IN-ATRIAL SEPTAL-2022-01
- Conditions
- Left Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Morningside (Nantong) Medical Co.,LtdUniversity, hospital or other
- Collaborators
- Xiamen Cardiovascular Hospital, Xiamen University
- Study start
- Aug 2022 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: Atrial shunt implant systemThis group contains patients with chronic left heart failure who are undergoing intervention in the atrial shunt implant system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial shunt implant systemPatients with chronic left heart failure who meet the conditions of the clinical trial undergo interventional surgery with the "Atrial Shunt Implant System" | Device | treatment group |
Primary outcome
The clinical treatment success rate was 12 months after operation
Time frame: Twelve months after surgery
Death and heart failure-related rehospitalization were avoided 12 months after surgery
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Results publication: PubMed 33501848Virani 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, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.
- Results publication: PubMed 31746111Hao 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.
- Results publication: PubMed 28461007Yancy 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 Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017 Aug 8;70(6):776-803. doi: 10.1016/j.jacc.2017.04.025. Epub 2017 Apr 28. No abstract available.
- Results publication: PubMed 34447992McDonagh 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 Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Results publication: PubMed 29029965Zhang 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.2017.09.014. Epub 2017 Oct 10.
- Results publication: PubMed 32202936Shah 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: 10.1161/CIRCULATIONAHA.119.041886. Epub 2020 Mar 23.
- Results publication: PubMed 17428822Paulus 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 and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007 Oct;28(20):2539-50. doi: 10.1093/eurheartj/ehm037. Epub 2007 Apr 11.
- Results publication: PubMed 24961390Sondergaard 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.
- Results publication: PubMed 25841123Malek F, Neuzil P, Gustafsson F, Kaye DM, Walton A, Mates M, Sondergaard L, Ihlemann N, Mariani JA, Reddy V. Clinical outcome of transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel implant. Int J Cardiol. 2015;187:227-8. doi: 10.1016/j.ijcard.2015.03.198. Epub 2015 Mar 18. No abstract available.
- Results publication: PubMed 27025436Hasenfuss G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016 Mar 26;387(10025):1298-304. doi: 10.1016/S0140-6736(16)00704-2.
- Results publication: PubMed 27852653Kaye DM, Hasenfuss G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Dec;9(12):e003662. doi: 10.1161/CIRCHEARTFAILURE.116.003662.
- Results publication: PubMed 30167646Shah SJ, Feldman T, Ricciardi MJ, Kahwash R, Lilly S, Litwin S, Nielsen CD, van der Harst P, Hoendermis E, Penicka M, Bartunek J, Fail PS, Kaye DM, Walton A, Petrie MC, Walker N, Basuray A, Yakubov S, Hummel SL, Chetcuti S, Forde-McLean R, Herrmann HC, Burkhoff D, Massaro JM, Cleland JGF, Mauri L. One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial: A Randomized Clinical Trial. JAMA Cardiol. 2018 Oct 1;3(10):968-977. doi: 10.1001/jamacardio.2018.2936.
- Guidelines for the diagnosis and treatment of heart failureLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yan wang, dean principal investigator
Xiamen Cardiovascular Hospital, Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial shunt implant system in people with Left Heart Failure, run by Morningside (Nantong) Medical Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yuchen liang, president (+8613774401524, ycliang@siriusmed.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical treatment success rate was 12 months after operation (time frame: Twelve months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486000, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.