Clinical trials: sponsored by Boston Scientific Corporation
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
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
OPTION-EMEA Clinical Trial
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with…
- Conditions
- Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation
- Trial name
- OPTION-EMEA (NCT07349121)
- Testing
- Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
- Where
- 11 sites in Belgium, Croatia and 3 more
- Volunteers
- 500 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
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
Persistent Atrial Fibrillation
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in…
- Trial name
- NCT07106970
- Testing
- Linear ablation, PVI alone
- Where
- China
- Volunteers
- 640 people
- Sponsor
- Boston Scientific Corporation
Acute Pulmonary Embolism
A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
This study to collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.
- Trial name
- ANTEATER (NCT06819865)
- Testing
- EkoSonicTM Endovascular System
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Boston Scientific Corporation
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
The goal of this clinical trial is to determine whether Endoscopic Sleeve Gastroplasty (ESG)-induced weight loss can improve glycemic outcomes and alter the trajectory toward insulin dependence in adults with obesity and…
- Trial name
- MEASURE (NCT07639684)
- Testing
- ESG with OverStitch
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
ADVENT Post Approval Study
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
- Trial name
- ADVENTPAS (NCT06431815)
- Testing
- FARAPULSE™ Pulsed Field Ablation System
- Where
- 30 sites in United States, Brazil and 2 more
- Volunteers
- 228 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.
- Trial name
- ReMATCH (NCT06735534)
- Testing
- FARAPULSE™ Pulsed Field Ablation System
- Where
- 41 sites in United States, Australia and 1 more
- Volunteers
- 376 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Pulsed Field Ablation
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation
The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field…
- Conditions
- Atrial Fibrillation, Pulsed Field Ablation, FARAPULSE
- Trial name
- OPALISE (NCT06808217)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 22 sites in Austria, France and 8 more
- Volunteers
- 550 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF)
FARAPULSE Workflow Assessment Registry
The study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE™ Pulsed Field…
- Trial name
- FARAWAY (NCT06656884)
- Where
- 28 sites in Austria, Belgium and 8 more
- Volunteers
- 524 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial…
- Trial name
- FARADIGM (NCT07575269)
- Testing
- FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
- Where
- 13 sites in United States, Belgium and 2 more
- Volunteers
- 571 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Persistent Atrial Fibrillation
Feasibility Study of the FARAFLEX Mapping and PFA System
The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or…
- Conditions
- Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF
- Trial name
- ELEVATE-PF (NCT06510556)
- Testing
- FARAFLEX Ablation Treatment, ELEVATE-COR Sub-study
- Where
- 4 sites in Belgium, Croatia and 2 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and…
- Trial name
- IMPULSE-EVO (NCT07444320)
- Testing
- FARAPULSE™ Pulsed Field Ablation (PFA) System
- Where
- 4 sites in Croatia, Czechia and 2 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources)…
- Trial name
- OPTIMIZE (NCT07187115)
- Testing
- FARAPOINT Pulsed Field Ablation System, OptiMap System (non-ablative), FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 699 people
- Sponsor
- Boston Scientific Corporation
Concomitant Procedures, Atrial Fibrillation
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and…
- Conditions
- Concomitant Procedures, Atrial Fibrillation, PFA, LAAC
- Trial name
- OPTION-A (NCT06686485)
- Testing
- FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
- Where
- 37 sites in China, Hong Kong and 4 more
- Volunteers
- 433 people
- Sponsor
- Boston Scientific Corporation
Cardiac Arrythmias
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
The objective of the RHAPSODY study is to evaluate the performance of new software features in subjects undergoing standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial…
- Trial name
- RHAPSODY (NCT03053141)
- Testing
- Rhythmia Mapping System
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation