Clinical trials: sponsored by Abbott Medical Devices
Movement Disorders, Parkinson Disease
A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study.
- Conditions
- Movement Disorders, Parkinson Disease, Essential Tremor, Tremor
- Trial name
- NCT03884231
- Testing
- Infinity DBS System with MR Conditional labelling
- Where
- 16 sites in United States, France and 3 more
- Volunteers
- 74 people
- Sponsor
- Abbott Medical Devices
Pain
Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
ROSTRA is an international, prospective, non-randomized, single-arm, multi-center, and post-market study to collect real-world safety and effectiveness data on Abbott's IonicRF™Generator and compatible RFA accessories.
- Trial name
- ROSTRA (NCT04873817)
- Testing
- IonicRF Generator and compatible accessories
- Where
- 11 sites in United States, Belgium and 4 more
- Volunteers
- 184 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Insufficiency
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification
- Trial name
- NCT03539458
- Testing
- Tendyne Mitral Valve System
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Abbott Medical Devices
Depressive Disorder, Major
European Deep Brain Stimulation (DBS) Depression Study
To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for treatment resistant Major Depressive Disorder…
- Trial name
- NCT01331330
- Testing
- Deep Brain Stimulation
- Where
- 5 sites in France, Israel and 1 more
- Volunteers
- 9 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
A Multi-centre Observational Study of the Axium Neurostimulator as a Treatment for Chronic Pain
08-SMI-2012 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic pain.
- Trial name
- PREDICT (NCT02169401)
- Testing
- Implantation with the commercially available Axium Neurostimulator
- Where
- United Kingdom
- Volunteers
- 135 people
- Sponsor
- Abbott Medical Devices
Cardiac Arrhythmia
EnSite Precision Observational Study
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software…
- Trial name
- NCT03260244
- Testing
- cardiac mapping and radiofrequency ablation procedure
- Where
- 7 sites in United States
- Volunteers
- 1,065 people
- Sponsor
- Abbott Medical Devices
Tricuspid Valve Insufficiency
TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical…
- Trial name
- TRILUMINATE (NCT03227757)
- Testing
- Tricuspid Valve Repair System
- Where
- 20 sites in United States, France and 4 more
- Volunteers
- 98 people
- Sponsor
- Abbott Medical Devices
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Post-Infarction Ventricular Septal Defect
The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017.
- Trial name
- PIVSD PAS (NCT03165526)
- Testing
- AMPLATZER™ Post-infarct Muscular VSD Occluder
- Where
- 17 sites in United States
- Volunteers
- 131 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Atrial Fibrillation
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.
- Trial name
- PAFOS (NCT01912326)
- Testing
- Pacemaker Implantation
- Where
- Germany
- Volunteers
- 249 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Sinus Node Dysfunction
LBBAP Data Collection Registry
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT05887323
- Testing
- Implantation of the Tendril 2088 lead in the LBBA
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 221 people
- Sponsor
- Abbott Medical Devices
Neck Pain, Upper Limb Pain
Treatment of Neck and Upper Limb Pain Using BurstDR (De Ridder) Stimulation
This is a prospective, open label, multicenter feasibility study to evaluate the safety and therapeutic efficacy of BurstDRTM SCS in treating chronic neck pain with or without radiation down to arm/shoulder/upper back
- Trial name
- NU-BURST (NCT03159169)
- Testing
- Spinal Cord Stimulation (SCS)
- Where
- 3 sites in United Kingdom
- Volunteers
- 17 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain
The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments.
- Trial name
- NCT02587637
- Testing
- Dorsal root ganglion (DRG) stimulation
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
- Trial name
- REDO-FIRM (NCT02799043)
- Testing
- Standard PVI, FIRM-Guided Procedure and PVI
- Where
- 24 sites in United States, Belgium and 2 more
- Volunteers
- 269 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact…
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
- Trial name
- WAVE-MAP AF (NCT03882021)
- Testing
- A specific electrophysiology mapping protocol is applicable with the GRID catheter.
- Where
- 15 sites in Austria, Czechia and 7 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Parkinson Disease
Clinical Evaluation of the Infinity Deep Brain Stimulation System
The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad…
- Trial name
- PROGRESS (NCT02989610)
- Testing
- Omnidirectional stimulation, Directional stimulation
- Where
- 41 sites in United States, Australia and 6 more
- Volunteers
- 234 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Sinus Node Dysfunction
Physiologic Pacing Registry
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements…
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT03719040
- Testing
- Physiologic pacing device implant
- Where
- 50 sites in United States, Australia and 14 more
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
Ischemic Heart Disease, Angina Pectoris
Absorb GT1 Japan PMS
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for…
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion
- Trial name
- NCT03409731
- Testing
- ABSORB GT1 BVS
- Where
- 15 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
LSI (Lesion Index) Workflow Observational Study
This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter…
- Trial name
- NCT03906461
- Testing
- Radiofrequency Ablation
- Where
- 9 sites in United States, Germany and 3 more
- Volunteers
- 143 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Stenosis
ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)
The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent…
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Atherosclerosis, STEMI
- Trial name
- NCT03507777
- Testing
- Coronary PCI guided by OCT, Coronary PCI guided by Angiography
- Where
- 90 sites in United States, Australia and 18 more
- Volunteers
- 2,487 people
- Sponsor
- Abbott Medical Devices