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The purpose of this study is to determine if the Reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reducer | Experimental | Implant Reducer |
|
| Control | Sham Comparator | No treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neovasc Reducer | Device | Implantation of the Reducer |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Cardiovascular Society Angina Score | A decrease of two or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Successful delivery and deployment of the Reducer to the intended site as assessed by the investigator | 24 hours |
| Procedural success | Technical success and the absence of acute need for clinically-driven intervention to address an Adverse or Serious Adverse Device Effect prior to hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left SVC) and/or; CS diameter at the site of planned reducer implantation less than 9.5 mm or greater than 13 mm
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Verheye, MD | ZNA Middelheim Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middelheim Hospital | Antwerp | 2020 | Belgium | |||
| Ziekenhuis Oost-Limburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32719097 | Derived | Jolicoeur EM, Verheye S, Henry TD, Joseph L, Doucet S, White CJ, Edelman E, Banai S. A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina. Heart. 2021 Jan;107(1):41-46. doi: 10.1136/heartjnl-2020-316644. Epub 2020 Jul 21. | |
| 25651246 |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Device |
Control - No device implanted |
|
| 24 hours |
| Periprocedural Serious Adverse Event: | A composite of death, myocardial infarction, cardiac tamponade, clinically-driven re-dilation of a failed Reducer, life-threatening arrhythmia, and respiratory failure through 30 days post-procedure in the Reducer group. | 30 days |
| Periprocedural Serious Adverse Event | A composite of death, myocardial infarction, cardiac tamponade, life-threatening arrhythmia, and respiratory failure through 30 days post-procedure in the control group. | 30 days |
| Major Adverse Events | A composite of cardiac death, major stroke, and myocardial infarction in the Reducer and Control groups through hospital discharge, and at six-month post-procedural evaluations. | 6 months |
| Canadian Cardiovascular Society Angina Score | A decrease one or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups | 6 months |
| Dobutamine Echo Wall Motion Score Index | Wall motion score index in both the Reducer and control groups at baseline and six-month post-procedural evaluation | 6 months |
| Seattle Angina Questionnaire Score | Seattle Angina Questionnaire in the Reducer and Control groups at baseline and six-month post-procedural evaluation | 6 months |
| Exercise Tolerance Testing | Exercise Tolerance Testing in the Reducer and Control groups at baseline and six-month post-procedural evaluation | 6 months |
| Genk |
| 3600 |
| Belgium |
| Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Rigshospitalet | Copenhagen | DK-2100 | Denmark |
| UMC Utrecht | Utrecht | 3584 | Netherlands |
| Central Hospital Kristianstad | Kristianstad | 85 | Sweden |
| Royal Infirmary of Bradford | Bradford | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| King College Hospital | London | SE5 9RS | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| 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. |
| 23413981 | Derived | Jolicoeur EM, Banai S, Henry TD, Schwartz M, Doucet S, White CJ, Edelman E, Verheye S. A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial. Trials. 2013 Feb 15;14:46. doi: 10.1186/1745-6215-14-46. |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |