Clinical trials: sponsored by Abbott Medical Devices
Mitral Regurgitation, Mitral Valve Regurgitation
MitraClip NT System Post-marketing Surveillance Study - Japan
The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to…
- Trial name
- MitraClip NT (NCT03500692)
- Testing
- MitraClip NT System
- Where
- 40 sites in Japan
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
ABLATOR Brazil - Ablation Observational Study (Registry)
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of St. Jude Medical (SJM)/Abbott mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).
- Trial name
- NCT03041233
- Testing
- Observation / Data Collection
- Where
- 12 sites in Brazil
- Volunteers
- 833 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)
This is a prospective, longitudinal, single-center, non-randomized, open-label, post-market clinical feasibility study to assess the efficacy of neuromodulation therapies (SCS and DRG) for chronic pain patients with diabetes and…
- Trial name
- XANADO (NCT05537662)
- Testing
- Standard of care neuromodulation therapy (SCS or DRG)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.
- Trial name
- Prodigy-I (NCT02143791)
- Testing
- Burst and Tonic stimulation
- Where
- 21 sites in Australia, Belgium and 7 more
- Volunteers
- 126 people
- Sponsor
- Abbott Medical Devices
Complex Regional Pain Syndrome (CRPS)
TARGET Post-Approval Study
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation.
- Trial name
- TARGET PAS (NCT02800863)
- Testing
- Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System), Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
- Where
- 44 sites in United States
- Volunteers
- 426 people
- Sponsor
- Abbott Medical Devices
Parkinson Disease
IPG Replacement Study (PREFERENCE-H)
This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical…
- Trial name
- PREFERENCE-H (NCT02963259)
- Testing
- SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system
- Where
- 14 sites in United States, Germany and 1 more
- Volunteers
- 17 people
- Sponsor
- Abbott Medical Devices
Advanced Heart Failure
Hong Kong and Taiwan HM3 PMS
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04703855
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 3 sites in Hong Kong, Taiwan
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
Cardiac Resynchronization Therapy
ECGi of SyncAV With MultiPoint Pacing
The objective of this clinical study was to evaluate the impact of Multipoint Pacing (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence using noninvasive electrocardiographic imaging…
- Trial name
- NCT06444386
- Testing
- MPP + SyncAV
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional…
- Trial name
- INTELLECT 2-HF (NCT03247829)
- Testing
- Hemodynamic management using CardioMEMS HF System
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation
Persistent Atrial Fibrillation (AF) APAC (Asia Pacific) Observational Study
The objective of this clinical trial is to collect safety and effectiveness data for the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the APAC patient population for the treatment of drug…
- Trial name
- PerAF APAC (NCT04244396)
- Testing
- TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)
- Where
- 9 sites in Hong Kong, Singapore and 3 more
- Volunteers
- 82 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Left-Sided Heart Failure
CardioMEMS HF System Post Approval Study
The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.
- Conditions
- Heart Failure, Left-Sided Heart Failure, Congestive Heart Failure
- Trial name
- NCT02279888
- Testing
- CardioMEMS HF System
- Where
- United States
- Volunteers
- 1,214 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation, Ventricular Tachycardia
Advisor HD Grid Observational Study
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called…
- Trial name
- NCT03733392
- Testing
- Advisor HD Grid Mapping Catheter, Sensor Enabled
- Where
- 25 sites in Australia, Austria and 9 more
- Volunteers
- 379 people
- Sponsor
- Abbott Medical Devices
Depressive Disorder, Major, Unipolar Depression
Deep Brain Stimulation for Major Depressive Disorder
This study is designed as a prospective, multi-centered, double-blind, randomized, controlled 12-month pivotal study to evaluate the safety and efficacy of the ANS Libra® Deep Brain Stimulation System for patients with major…
- Trial name
- NCT00617162
- Testing
- Deep Brain Stimulation, Libra Deep Brain Stimulation System
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 125 people
- Sponsor
- Abbott Medical Devices
Ischemic Heart Disease, Angina Pectoris
XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE PRIME SV Japan PMS)
The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion
- Trial name
- NCT02513719
- Testing
- XIENCE PRIME SV Everolimus Eluting Coronary Stent
- Where
- 33 sites in Japan
- Volunteers
- 312 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Thromboembolism
AMPLATZER™ LAA Occluder Post Approval Study (PAS)
The aim of this multicenter, non-randomized observational post-approval is to compile real world outcome data on the use of an AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF).
- Conditions
- Atrial Fibrillation, Thromboembolism, Stroke
- Trial name
- NCT02964208
- Testing
- AMPLATZER™ LAA Occluder
- Where
- 22 sites in Argentina, Belgium and 5 more
- Volunteers
- 520 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
HD Mapping of Atrial Fibrillation in Asia Pacific
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop…
- Trial name
- NCT04022954
- Testing
- Catheter ablation
- Where
- 15 sites in China, Hong Kong and 3 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
CSI Percutaneous Ventricular Assist Device (pVAD) Second in Human Study
The purpose of this study is to collect data on safety and device performance on the CSI pVAD System used to support hemodynamic stability during HR-PCIs to inform device design and finalization.
- Trial name
- NCT05695716
- Testing
- CSI pVAD System
- Where
- Georgia
- Volunteers
- healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Heart Failure
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing
The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy (CRT) patients.
- Trial name
- NCT02782598
- Testing
- CRT+NAVH
- Where
- Italy
- Volunteers
- 17 people
- Sponsor
- Abbott Medical Devices
Heart Failure
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy
The purpose of this study is to evaluate the application of Negative Atrioventricular Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT) patients.
- Trial name
- NCT02903940
- Testing
- CRT+NAVH
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Cardiovascular Systems Inc. (CSI) pVAD First in Human Study
This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
- Trial name
- NCT05315544
- Testing
- CSI pVAD system
- Where
- Georgia
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices