Clinical trials: Myocardial Diseases
Ventricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled…
- Trial name
- NCT07585968
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 7 sites in United States
- Volunteers
- 260 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.
- Conditions
- Coronary Artery Disease, Atherosclerosis of Coronary Artery, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOMAG-LL (NCT07091682)
- Testing
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Where
- 14 sites in Germany, Hungary and 5 more
- Volunteers
- 100 people
- Sponsor
- Biotronik AG
Heart Failure, Ischemic Heart Disease
A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)
The purpose of this clinical study is to evaluate the safety and efficacy of HS-001 CS transplanted into severe heart failure patients with underlying ischemic heart disease for 26 weeks after transplantation.
- Trial name
- LAPiS (NCT04945018)
- Testing
- HS-001 CS, HS-001-D needle, HS-001-D Adaptor
- Where
- 8 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Heartseed Inc.
Heart Failure, Ischemic Heart Failure
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
The purpose of this clinical study is to evaluate the safety and efficacy of endocardial delivery of HS-001 CS into severe heart failure patients with reduced ejection fraction for 26 weeks after transplantation.
- Conditions
- Heart Failure, Ischemic Heart Failure, Ischemic Heart Disease, Dilated Cardiomyopathy (DCM)
- Trial name
- EMERALD (NCT07347197)
- Testing
- HS-005
- Where
- 5 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Heartseed Inc.
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE ONYX China RCT Study
It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary…
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- NCT03466151
- Testing
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
- Where
- 2 sites in China
- Volunteers
- 550 people
- Sponsor
- Medtronic Vascular
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE ONYX China Single Arm Study
It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de…
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- NCT03471845
- Testing
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- Where
- China
- Volunteers
- 591 people
- Sponsor
- Medtronic Vascular
Ischemic Heart Disease (IHD)
A Clinical Evaluation of AMJ-401
A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan
- Trial name
- NCT07373353
- Testing
- AMJ-401
- Where
- 10 sites in Japan
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Cardiovascular Disease and Lipoprotein(a)
An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).
- Trial name
- NCT07517263
- Testing
- Pelacarsen (TQJ230)
- Where
- 646 sites in United States, Argentina and 38 more
- Volunteers
- 5,700 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myocardial Infarction, Restenoses, Coronary
Abbott Vascular Medical Device Registry
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use…
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism
- Trial name
- AV-MDR (NCT04573660)
- Testing
- Coronary and peripheral stents, Pacing catheters, Vascular plugs
- Where
- 37 sites in United States, Australia and 12 more
- Volunteers
- 3,784 people
- Sponsor
- Abbott Medical Devices
Angina Pectoris, Myocardial Ischemia
Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)
VahatiCor's Coronary Sinus Reducer (A-FLUX) has been designed to improve angina or angina-like symptoms in patients with CMD. SERRA-I is an early feasibility study that evaluates the safety and clinical performance of the A-FLUX…
- Conditions
- Angina Pectoris, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases
- Trial name
- SERRA-I US (NCT07449325)
- Testing
- A-FLUX Reducer System
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- VahatiCor, Inc.
Coronary Artery Disease
SELUTION 4 De Novo Small Vessel IDE Trial
Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as…
- Trial name
- NCT05946629
- Testing
- PCI with SELUTION SLR DCB, PCI with FDA approved "-limus" DES
- Where
- 70 sites in United States, Belgium and 1 more
- Volunteers
- 960 people
- Sponsor
- M.A. Med Alliance S.A.
Atherosclerosis, Cardiovascular Disease
A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease
The purpose of this study is to measure the change in bad cholesterol (LDL-C) with VERVE-102 compared to placebo in adults who have plaque buildup in their arteries or are at high risk of developing it.
- Conditions
- Atherosclerosis, Cardiovascular Disease, Hypercholesterolemia
- Trial name
- HEART-3 (NCT07839936)
- Testing
- VERVE-102
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- Verve Therapeutics, Inc.
End Stage Kidney Disease
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo.
- Trial name
- POSIBIL6ESKD (NCT05485961)
- Testing
- CSL300
- Where
- 566 sites in United States, Argentina and 33 more
- Volunteers
- 3,110 people
- Sponsor
- CSL Behring
Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
"Discovery2" Study of Using MCG at Emergency Departments
The purpose of this research is to collect the magnetic signals from the heart to identify features that may help Emergency Department (ED) doctors differentiate high and low risk patients for heart related chest pain.
- Conditions
- Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD), Chest Pain, NSTE-ACS (NSTEMI and UA)
- Trial name
- Discovery2 (NCT07822581)
- Testing
- Magnetocardiography
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- SB Technology, Inc.
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
The goal of this clinical trial is to learn if the SiroMax™ drug-coated balloon catheter is safe and works to treat stenotic coronary lesions in adults.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), In-Stent Restenosis or De Novo Coronary Artery Lesions, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Trial name
- SMART-I (NCT07811024)
- Testing
- Sirolimus-coated balloon catheter
- Where
- 2 sites in Uzbekistan
- Volunteers
- 60 people
- Sponsor
- Tonic Medical, Inc.
Primary Prevention of Atherosclerotic Cardiovascular Disease
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at…
- Trial name
- NCT05739383
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- 983 sites in United States, Argentina and 40 more
- Volunteers
- 14,012 people
- Sponsor
- Novartis Pharmaceuticals
Major Cardiovascular Event, Established Atherosclerotic Cardiovascular Disease
A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease
The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI)…
- Trial name
- NCT06295679
- Where
- 90 sites in China
- Volunteers
- 7,000 people
- Sponsor
- Amgen
Ventricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the…
- Trial name
- NCT06703489
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Coronary Disease, Heart Diseases
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions
The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- BIOMAG-III (NCT07258290)
- Testing
- Freesolve RMS, Xience DES
- Where
- 3 sites in United States, Latvia
- Volunteers
- 1,859 people
- Sponsor
- Teleflex
Cardiovascular Disease and Lipoprotein(a)
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
- Trial name
- Lp(a)HORIZON (NCT04023552)
- Testing
- TQJ230
- Where
- 902 sites in United States, Argentina and 41 more
- Volunteers
- 8,323 people
- Sponsor
- Novartis Pharmaceuticals