Clinical trials: sponsored by Abbott Medical Devices
Heart Failure
CardioMEMS HF System Coverage With Evidence Development Study
The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the…
- Trial name
- NCT06779552
- Testing
- CardioMEMS HF System
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation
TriClip Japan Post-Approval Study
The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following…
- Trial name
- TriClip JP PAS (NCT07509658)
- Testing
- The TriClip System
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Abbott Medical Devices
Chronic Limb-Threatening Ischemia
Esprit BTK Post-Approval Study
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients…
- Trial name
- EspritBTKPAS (NCT06656364)
- Testing
- Esprit BTK System
- Where
- 39 sites in United States, Hong Kong and 2 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Ventricular Arrythmia
ASCEND CSP IDE Study
This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy.
- Trial name
- ASCEND CSP IDE (NCT06830746)
- Testing
- LBBAP Implant with a CSP ICD Lead
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 414 people
- Sponsor
- Abbott Medical Devices
PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect
Trevisio Post-Approval Study
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
- Conditions
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Trial name
- TrevisioPAS (NCT04433520)
- Testing
- Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
- Where
- 22 sites in France, Germany and 5 more
- Volunteers
- 254 people
- Sponsor
- Abbott Medical Devices
Cardiac Rhythm Disorder
EP Device Registry
This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.
- Trial name
- NCT04460209
- Testing
- Standard of Care
- Where
- 26 sites in Austria, Czechia and 8 more
- Volunteers
- 5,003 people
- Sponsor
- Abbott Medical Devices
Stroke, Patent Foramen Ovale
AMPLATZER PFO Occluder Post Approval Study
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
- Trial name
- PFO PAS (NCT03309332)
- Testing
- AMPLATZER™ PFO Occluder
- Where
- 88 sites in United States, Canada and 5 more
- Volunteers
- 1,214 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
XIENCE Skypoint Large Vessel Post Approval Study
SPIRIT XLV PAS is a prospective, single arm, multi-center, US and OUS post-approval observational study to evaluate the continued safety and effectiveness of the XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent…
- Trial name
- SPIRIT XLV PAS (NCT05423379)
- Testing
- XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)
- Where
- 18 sites in United States, France and 1 more
- Volunteers
- 102 people
- Sponsor
- Abbott Medical Devices
Paravalvular Aortic Regurgitation
PARADIGM: Amplatzer Valvular Plug for PVL Closure
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant…
- Trial name
- PARADIGM (NCT04489823)
- Testing
- AVP III
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Stroke
Amplatzer Amulet LAAO vs. NOAC
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for…
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- CATALYST (NCT04226547)
- Testing
- Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Non-Vitamin K Oral Antagonists
- Where
- 127 sites in United States, Australia and 14 more
- Volunteers
- 2,650 people
- Sponsor
- Abbott Medical Devices
Symptomatic Severe Aortic Stenosis
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
- Trial name
- NCT07116551
- Testing
- Abbott BE TAVI System
- Where
- 5 sites in United States, France
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation Paroxysmal
FOCALFLEX (CE Mark) Study
This clinical investigation is intended to demonstrate safety and effectiveness of the TactiFlex™ Ablation Catheter Sensor Enabled™, the Volt™ Pulse Field Ablation (PFA) Generator, and EnSite™ X EP System with EnSite™ Pulsed…
- Trial name
- NCT06271967
- Testing
- TactiFlex™ Ablation Catheter Sensor Enabled™
- Where
- 24 sites in Australia, Austria and 9 more
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia (CLI)
LIFE-BTK PK Sub-study
LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside…
- Trial name
- NCT05208905
- Testing
- Esprit BTK Device
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 9 people
- Sponsor
- Abbott Medical Devices
Movement Disorders, Parkinson Disease
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling…
- Conditions
- Movement Disorders, Parkinson Disease, Essential Tremor, Tremor
- Trial name
- ADROIT (NCT04071847)
- Testing
- Deep Brain Stimulation (DBS)
- Where
- 48 sites in United States, Australia and 7 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator
The REALITY study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with Abbott's…
- Trial name
- REALITY (NCT03876054)
- Testing
- Spinal cord stimulation (SCS), Dorsal root ganglion stimulation (DRG)
- Where
- 55 sites in United States, Australia and 7 more
- Volunteers
- 2,000 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia (CLI)
LIFE-BTK Randomized Controlled Trial
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed…
- Trial name
- LIFE-BTK (NCT04227899)
- Testing
- Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 50 sites in United States, Australia and 4 more
- Volunteers
- 261 people
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure
SyncAV Post-Market Trial
The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices…
- Trial name
- SyncAV (NCT04100148)
- Testing
- SyncAV programmed ON, Fixed AV delay
- Where
- 104 sites in United States, Austria and 23 more
- Volunteers
- 1,686 people
- Sponsor
- Abbott Medical Devices
Peripheral Venous Thrombosis, Peripheral Arterial Thrombosis
JETi Hong Kong Post Market Study (PMS)
The JETi Hong Kong PMS is a single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the peripheral…
- Conditions
- Peripheral Venous Thrombosis, Peripheral Arterial Thrombosis, Peripheral Arteriovenous Thrombosis
- Trial name
- NCT06340763
- Testing
- JETi Hydrodynamic Thrombectomy System
- Where
- 4 sites in Hong Kong
- Volunteers
- 12 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation
MitraClip China PMS
The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for…
- Trial name
- NCT04259411
- Testing
- MitraClip procedure
- Where
- 5 sites in China
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Atrial Arrhythmia, Atrium; Fibrillation
Abbott Atrial Fibrillation Post Approval Study
This post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g.
- Conditions
- Atrial Arrhythmia, Atrium; Fibrillation, Atrial Tachycardia
- Trial name
- NCT05434650
- Testing
- electrophysiology study and ablation with an Abbott Ablation Catheter
- Where
- 20 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices