Clinical trials: sponsored by Abbott Medical Devices
- Sponsor Abbott Medical Devices
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Patent Ductus Arteriosus
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect…
- Trial name
- NCT04371081
- Testing
- Amplatzer Piccolo Occluder
- Where
- Japan
- Volunteers
- 70 people
- Sponsor
- Abbott Medical Devices
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
PFO - Patent Foramen Ovale
Amplatzer PFO Occluder Post-marketing Surveillance Study
The purpose of the Amplatzer PFO Occluder 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…
- Trial name
- PFO PMS Jpn (NCT04349995)
- Testing
- Amplatzer PFO Occluder
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Leadless Pacemaker
Aveir Leadless Pacemaker Japan PMS
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing.
- Trial name
- NCT07106788
- Testing
- Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients, Upgrades
- Where
- 14 sites in Japan
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15…
- Trial name
- NCT03924661
- Testing
- Aortic Valve Replacement
- Where
- 13 sites in United States, Germany
- Volunteers
- 20 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
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
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
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
Ventricular Tachycardia
Abbott Ventricular Tachycardia PAS
This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of…
- Trial name
- NCT05839873
- Testing
- FlexAbility SE Ablation Catheter
- Where
- 11 sites in United States
- Volunteers
- 62 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation, Mitral Regurgitation
MitraClip EXPAND G4 Study
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
- Trial name
- NCT04177394
- Testing
- MitraClip G4 System
- Where
- 63 sites in United States, Canada and 8 more
- Volunteers
- 1,164 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Cardiovascular Disease
HeartMate 3 ELEVATE™ Registry
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
- Conditions
- Heart Failure, Cardiovascular Disease, Ventricular Dysfunction
- Trial name
- ELEVATE™ (NCT02497950)
- Testing
- HeartMate 3
- Where
- 26 sites in Austria, Czechia and 9 more
- Volunteers
- 540 people
- Sponsor
- Abbott Medical Devices
Ventricular Septal Defects
Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER…
- Trial name
- VPA (NCT00647387)
- Testing
- Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
- Where
- 51 sites in United States, Canada
- Volunteers
- 92 people
- Sponsor
- Abbott Medical Devices
Patent Ductus Arteriosus
AMPLATZER Duct Occluder II Additional Sizes
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA).
- Trial name
- ADO II AS (NCT03055858)
- Testing
- ADO II AS (PDA closure)
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Disease, Damaged Mitral Valve
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially…
- Conditions
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
- Trial name
- NCT02097420
- Testing
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- Where
- 24 sites in United States
- Volunteers
- 23 people
- Sponsor
- 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
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
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
Cardiogenic Shock
Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
The primary objective of this study is to assess reasonable safety and performance of the HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic shock requiring stabilization.
- Trial name
- NCT02279979
- Testing
- HeartMate PHP
- Where
- 6 sites in Czechia, Germany and 2 more
- Volunteers
- 9 people
- Sponsor
- Abbott Medical Devices