CoROnary SinuS Reducer implantatiOn for ischemiA reDuction
NCT ID: NCT04121845
Last Updated: 2022-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2019-01-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment group
Coronary sinus reducer implantation through right internal jugular vein.
Coronary Sinus Reducer device
Coronary sinus reducer device (Neovasc, Richomnd, Canada) implantation in the coronary sinus. The procedure is performed in the cardiac catheterization laboratory through right internal jugular vein.
Sham group
Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.
Sham procedure
Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.
Interventions
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Coronary Sinus Reducer device
Coronary sinus reducer device (Neovasc, Richomnd, Canada) implantation in the coronary sinus. The procedure is performed in the cardiac catheterization laboratory through right internal jugular vein.
Sham procedure
Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.
Eligibility Criteria
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Inclusion Criteria
* receiving optimal medical therapy for at least one month
* confirmed reversible myocardial ischemia in left anterior descending coronary artery (LAD) and/or left circumflex coronary artery (LCX) territory by SPECT
* not candidate for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
Exclusion Criteria
* recent acute coronary syndrome (within 3 months)
* recent successful PCI and/or CABG (within 6 months)
* decompensated heart failure and/or recent (within 3 months) hospitalization due to heart failure
* severe heart valve(s) disease
* advanced chronic obstructive pulmonary disease (COPD) or poorly managed asthma
* peripheral arterial disease, musculoskeletal disorder or central nervous system disease which preclude exercise testing
18 Years
85 Years
ALL
No
Sponsors
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University Medical Centre Ljubljana
OTHER
Responsible Party
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Matjaž Bunc
Head of catheterization laboratory
Principal Investigators
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Matjaž Bunc, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Medical Centre Ljubljana, Slovenia
David Žižek, Assoc. Prof.
Role: STUDY_CHAIR
University Medical Centre Ljubljana, Slovenia
Locations
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University Medical Centre Ljubljana
Ljubljana, , Slovenia
Countries
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References
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Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Luscher T, Pasic M, Thelle D. The problem of chronic refractory angina; report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J. 2002 Mar;23(5):355-70. doi: 10.1053/euhj.2001.2706. No abstract available.
Henry TD, Satran D, Hodges JS, Johnson RK, Poulose AK, Campbell AR, Garberich RF, Bart BA, Olson RE, Boisjolie CR, Harvey KL, Arndt TL, Traverse JH. Long-term survival in patients with refractory angina. Eur Heart J. 2013 Sep;34(34):2683-8. doi: 10.1093/eurheartj/eht165. Epub 2013 May 12.
Giannini F, Aurelio A, Jabbour RJ, Ferri L, Colombo A, Latib A. The coronary sinus reducer: clinical evidence and technical aspects. Expert Rev Cardiovasc Ther. 2017 Jan;15(1):47-58. doi: 10.1080/14779072.2017.1270755.
Konigstein M, Verheye S, Jolicoeur EM, Banai S. Narrowing of the Coronary Sinus: A Device-Based Therapy for Persistent Angina Pectoris. Cardiol Rev. 2016 Sep-Oct;24(5):238-43. doi: 10.1097/CRD.0000000000000101.
Verheye S, Jolicoeur EM, Behan MW, Pettersson T, Sainsbury P, Hill J, Vrolix M, Agostoni P, Engstrom T, Labinaz M, de Silva R, Schwartz M, Meyten N, Uren NG, Doucet S, Tanguay JF, Lindsay S, Henry TD, White CJ, Edelman ER, Banai S. Efficacy of a device to narrow the coronary sinus in refractory angina. N Engl J Med. 2015 Feb 5;372(6):519-27. doi: 10.1056/NEJMoa1402556.
Konigstein M, Meyten N, Verheye S, Schwartz M, Banai S. Transcatheter treatment for refractory angina with the Coronary Sinus Reducer. EuroIntervention. 2014 Feb;9(10):1158-64. doi: 10.4244/EIJV9I10A196.
Abawi M, Nijhoff F, Stella PR, Voskuil M, Benedetto D, Doevendans PA, Agostoni P. Safety and efficacy of a device to narrow the coronary sinus for the treatment of refractory angina: A single-centre real-world experience. Neth Heart J. 2016 Sep;24(9):544-51. doi: 10.1007/s12471-016-0862-2.
Banai S, Ben Muvhar S, Parikh KH, Medina A, Sievert H, Seth A, Tsehori J, Paz Y, Sheinfeld A, Keren G. Coronary sinus reducer stent for the treatment of chronic refractory angina pectoris: a prospective, open-label, multicenter, safety feasibility first-in-man study. J Am Coll Cardiol. 2007 May 1;49(17):1783-9. doi: 10.1016/j.jacc.2007.01.061.
Myers J, Froelicher VF. Optimizing the exercise test for pharmacological investigations. Circulation. 1990 Nov;82(5):1839-46. doi: 10.1161/01.cir.82.5.1839.
Kralios AC, Nappi JM, Tsagaris TJ, Kralios FA, Kuida H. Paradoxical increase of ventricular fibrillation threshold in response to coronary sinus obstruction. Am Heart J. 1988 Feb;115(2):334-40. doi: 10.1016/0002-8703(88)90479-6.
Kralios AC, Anderson FL, Kralios FA. Protective effect of coronary sinus obstruction from primary ischemia-induced ventricular fibrillation in the dog. Am Heart J. 1993 Apr;125(4):987-95. doi: 10.1016/0002-8703(93)90105-i.
De Maria GL, Kassimis G, Raina T, Banning AP. Reconsidering the back door approach by targeting the coronary sinus in ischaemic heart disease. Heart. 2016 Aug 15;102(16):1263-9. doi: 10.1136/heartjnl-2016-309642. Epub 2016 Jun 10.
Baldetti L, Colombo A, Banai S, Latib A, Esposito A, Palmisano A, Giannini F. Coronary sinus Reducer non-responders: insights and perspectives. EuroIntervention. 2018 Feb 20;13(14):1667-1669. doi: 10.4244/EIJ-D-17-00626.
Mrak M, Zlahtic T, Starc V, Ivanovski M, Bunc M, Zizek D. The Impact of Coronary Sinus Reducer on Arrhythmic Properties in Patients with Refractory Angina. Rev Cardiovasc Med. 2023 Dec 26;24(12):368. doi: 10.31083/j.rcm2412368. eCollection 2023 Dec.
Other Identifiers
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CrossRoad
Identifier Type: -
Identifier Source: org_study_id
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