Clinical trials: sponsored by Boston Scientific Corporation
Heart Failure - NYHA II - IV
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left…
- Trial name
- SYNCHRONICITY (NCT07069738)
- Testing
- CRT-D with a Quadripolar LV lead, CRT-D with INGEVITY+ pace/sense lead
- Where
- 43 sites in United States
- Volunteers
- 850 people
- Sponsor
- Boston Scientific Corporation
In-Stent Restenosis
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length…
- Trial name
- AGENT IDE (NCT06492174)
- Testing
- AGENT DCB 40 mm
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Cardiac Disease
BoStOn SCientific Rhythm MAnagemenT REgiStry
SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the…
- Trial name
- SOCRATES (NCT04823663)
- Testing
- Implant, Electrophysiologic procedure
- Where
- 26 sites in Belgium, Canada and 8 more
- Volunteers
- 12,500 people
- Sponsor
- Boston Scientific Corporation
In-Stent Restenosis
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in…
- Trial name
- AGENT IDE (NCT04647253)
- Testing
- AGENT DCB, PTCA balloon catheter
- Where
- 40 sites in United States
- Volunteers
- 600 people
- Sponsor
- Boston Scientific Corporation
Cardiotoxicity, Cancer
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
This pilot study will evaluate the validity and feasibility of ambulatory cardiac monitoring to identify markers of cardiotoxicity in adults undergoing cancer treatment.
- Conditions
- Cardiotoxicity, Cancer, Cardiac Arrhythmia, Left Ventricular Dysfunction
- Trial name
- NCT07776964
- Testing
- Mobile Cardiac Telemetry, Wearable Cardiac Monitor
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Minnesota
Glioblastoma Multiforme, Recurrent Glioblastoma
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
The FRONTIER Study is a prospective, interventional, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.
- Trial name
- FRONTIER (NCT05303467)
- Testing
- TheraSphere GBM
- Where
- 9 sites in United States
- Volunteers
- 36 people
- Sponsor
- Boston Scientific Corporation
Hepatocellular Carcinoma (HCC)
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
- Trial name
- ADVANCE-MCD (NCT07669727)
- Testing
- TheraSphere
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
Prostate, Cancer
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
The VOYAGER Study is an interventional, non-randomized, single-arm, dose escalation trial with the goal of determining the safety of TheraSphere PCa device in patients with clinically localized prostate cancer across US-based…
- Trial name
- VOYAGER (NCT06192758)
- Testing
- TheraSphere PCa
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Boston Scientific Corporation
Motor Epilepsy
Combined CM and STN Stimulation for Motor Epilepsy
This self-crossover, randomized controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant…
- Trial name
- CoSMos (NCT07458217)
- Testing
- Deep brain stimulation
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Hepatocellular Carcinoma
TheraSphere With Durvalumab and Tremelimumab for HCC
The objective of the ROWAN clinical study is to assess the efficacy of local tumor control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab.
- Trial name
- ROWAN (NCT05063565)
- Testing
- TheraSphere Y-90 glass microsphere therapy, Durvalumab (Imfinzi) immunotherapy, Tremelimumab immunotherapy
- Where
- 35 sites in United States, France and 3 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Carotid Artery Stenosis
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
The study is a prospective, non-randomized, single-arm, multi-center registry to confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese…
- Trial name
- ASCENT-C (NCT07458243)
- Testing
- transcarotid artery revascularization
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.
- Trial name
- DANLOGIC-HF (NCT06099158)
- Testing
- HeartLogic
- Where
- 5 sites in Denmark
- Volunteers
- 1,428 people
- Sponsor
- Tor Biering-Sørensen
Atrial Fibrillation (AF)
BOdygUardian MOnitoriNg for ReCurrencE of AF
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the FARAPULSE Pulsed Field Ablation (PFA) System for the treatment of atrial…
- Trial name
- BOUNCE-AF (NCT07671677)
- Testing
- BodyGuardian
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
Heart Failure, Congestive Heart Failure
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and…
- Trial name
- NECTAR-HF (NCT01385176)
- Testing
- Implant of investigational device system, Titration during the randomization phase, Titration after the randomization phase
- Where
- 21 sites in Belgium, Czechia and 6 more
- Volunteers
- 118 people
- Sponsor
- Boston Scientific Corporation
Cardiovascular Diseases
A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China
A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System…
- Trial name
- NCT03736226
- Testing
- SYNERGYTM Stent System
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal AF
FARAPULSE™ Pulsed Field Ablation System
To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
- Trial name
- NCT06762717
- Testing
- FARAPULSE™ Pulsed Field Ablation system
- Where
- China
- Volunteers
- 501 people
- Sponsor
- Boston Scientific Corporation
Weight Loss
OverStitch NXT Endoscopic Suture System
To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication.
- Trial name
- NCT07276815
- Testing
- OverStitch NXT Endoscopic Suture System
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Boston Scientific Corporation
Weight Loss
Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')
To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.
- Trial name
- NCT07195708
- Testing
- Treatment group
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Boston Scientific Corporation
Bradycardia, Atrioventricular Block
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in…
- Conditions
- Bradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block
- Trial name
- SEPTA PMCF (NCT07209852)
- Testing
- Pacemaker lead
- Where
- 13 sites in Belgium, France and 5 more
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
Cardiogenic Shock
Cardiogenic Shock Working Group Registry
The Cardiogenic Shock Working Group is a multicenter registry where we collect de-identified clinical variables from the medical records and follow-up phone calls of shock patients from multiple institutions and centralize this…
- Trial name
- CSWG (NCT04682483)
- Testing
- Vasopressor, Inotrope, Acute Mechanical Circulatory Support Devices
- Where
- 16 sites in United States
- Volunteers
- 20,000 people
- Sponsor
- Tufts Medical Center