Clinical trials: sponsored by Abbott Medical Devices
Coronary Artery Disease
Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using: A composite of MACE at 30-day and one (1) year post procedure, and…
- Trial name
- MACE (NCT01930214)
- Testing
- Percutaneous Coronary Intervention
- Where
- 34 sites in United States
- Volunteers
- 350 people
- Sponsor
- Abbott Medical Devices
Peripheral Artery Disease, PAD
Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal
IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in…
- Conditions
- Peripheral Artery Disease, PAD, Claudication, Peripheral Vascular Disease
- Trial name
- TRUTH (NCT01938391)
- Testing
- Stealth 360°® OAS
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects.
- Trial name
- ORBIT II (NCT01092416)
- Testing
- Diamondback 360 Orbital Atherectomy System
- Where
- 51 sites in United States
- Volunteers
- 443 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Coronary Flow Reserve Following Orbital Atherectomy
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
- Trial name
- NCT02339545
- Testing
- Coronary Orbital Atherectomy plus Stenting
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
CAD
Coronary Orbital Atherectomy System Study
The purpose of the COAST clinical study data will be to utilize and to gain approval for commercializing the Micro Crown as part of the Coronary Orbital Atherectomy System (OAS).
- Trial name
- COAST (NCT02132611)
- Testing
- Diamondback 360® Coronary OAS Micro Crown
- Where
- 17 sites in United States, Japan
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices
Peripheral Artery Disease
Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
- Trial name
- REACH PVI (NCT03943160)
- Testing
- Diamondback 360 Extended Length Orbital Atherectomy System
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
PAD, Vascular Calcification
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of…
- Trial name
- OPTIMIZE BTK (NCT02561299)
- Testing
- Peripheral Orbital Atherectomy System, 014 Drug Coated Balloon
- Where
- 7 sites in Austria, Germany
- Volunteers
- 66 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Occlusive Disease
Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
The purpose of this study is to evaluate acute and long term clinical and economic outcomes of endovascular procedures to treat Peripheral Arterial Disease (PAD).
- Trial name
- LIBERTY (NCT01855412)
- Testing
- PAD endovascular treatments
- Where
- 52 sites in United States
- Volunteers
- 1,204 people
- Sponsor
- Abbott Medical Devices
Atrial Flutter
Gen2 Isthmus-Dependent Atrial Flutter Ablation Study
Irrigated catheter for ablation of isthmus-dependent atrial flutter
- Trial name
- NCT00606463
- Testing
- Cardiac Ablation (Gen2 Cardiac Ablation System)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Ischemic Cardiomyopathy, LV Dysfunction
Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study)
The ABCD clinical study is designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in patients with ischemic heart disease, left…
- Trial name
- NCT00187291
- Testing
- T-Wave Alternans test
- Volunteers
- 618 people
- Sponsor
- Abbott Medical Devices
Patent Ductus Arteriosus (PDA)
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus.
- Trial name
- NCT00583596
- Testing
- Device closure with AMPLATZER Duct Occluder, Objective Performance Criteria
- Where
- 24 sites in United States
- Volunteers
- 436 people
- Sponsor
- Abbott Medical Devices
Migraine
STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?
The primary objective of this Study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9…
- Trial name
- NCT00369499
- Testing
- PFO Closure
- Where
- Germany
- Volunteers
- 656 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Left Atrial Appendage
AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol
The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in subjects with nonvalvular atrial fibrillation…
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Stroke
- Trial name
- ACPR (NCT01786486)
- Testing
- Amplatzer Cardiac Plug
- Where
- 15 sites in Czechia, Germany and 3 more
- Volunteers
- 204 people
- Sponsor
- Abbott Medical Devices
Heart Failure
MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing
The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6…
- Trial name
- MORE CRT MPP (NCT02006069)
- Testing
- MPP
- Where
- 206 sites in United States, Australia and 28 more
- Volunteers
- 5,850 people
- Sponsor
- Abbott Medical Devices
Tremor, Action Tremor
Deep Brain Stimulation (DBS) for the Suppression of Tremor
The purpose of the proposed study is to demonstrate the safety and efficacy of the ANS Totally Implantable Deep Brain Stimulation System in the VIM nucleus of the thalamus implanted for the treatment of tremor due to essential…
- Conditions
- Tremor, Action Tremor, Essential Tremor, Tremor, Limb
- Trial name
- NCT02087046
- Testing
- ANS Totally Implantable Deep Brain Stimulation System
- Where
- 12 sites in United States
- Volunteers
- 127 people
- Sponsor
- Abbott Medical Devices
Advanced Refractory Left Ventricular Heart Failure
Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS).
- Trial name
- SWIFT (NCT04548128)
- Testing
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Where
- 32 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.
- Trial name
- CHARACTER SCS (NCT02250469)
- Testing
- Treatment with the Axium SCS system, Treatment with the Medtronic SCS System
- Where
- Netherlands
- Volunteers
- 5 people
- Sponsor
- Abbott Medical Devices
Parkinson's Disease
Post Market (Libra/LibraXP System) Deep Brain Stimulation (DBS) Parkinson's Disease Study
The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately…
- Trial name
- NCT01352819
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 21 people
- Sponsor
- Abbott Medical Devices
Cardiac Resynchronization Therapy, Heart Failure
Septal Mapping And Resynchronisation Therapy- (SMART) Study
Normal heart function involves rhythmic contraction of all four chambers of the heart and this rhythm is maintained by the electrical wiring (conduction system) of the heart.
- Trial name
- NCT04595305
- Testing
- Cardiac resynchronization therapy by CRT-P or CRT-D implantation
- Where
- Australia
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
Ventricular Arrythmia
Non-vascular ICD Electrode Configuration Feasibility Study
This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.
- Trial name
- NCT04809701
- Testing
- Temporary implantation of defibrillation coils and pulse generator, Defibrillation following induction of VA (Configuration A first), Defibrillation following induction of VA (Configuration B first)
- Where
- 3 sites in Chile, Czechia and 1 more
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices