Clinical trials: sponsored by 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
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
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
Heart Failure, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121472
- Testing
- Thoratec HeartMate II Left Ventricular Assist System (LVAS)
- Where
- 36 sites in United States, Canada
- Volunteers
- 194 people
- Sponsor
- Abbott Medical Devices
Right Ventricular Failure
CentriMag RVAS U.S. Post-approval Study Protocol
The study objective is to gather post-market clinical data on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any…
- Trial name
- CMagRVAS (NCT01568424)
- Testing
- CentriMag RVAS placement
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure Treated
Clinical Benefits in Optimized Remote HF Patient Management
The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or…
- Trial name
- COR-HF (NCT01482598)
- Testing
- Remote Care Follow up
- Where
- 18 sites in Italy
- Volunteers
- 144 people
- Sponsor
- Abbott Medical Devices
Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI…
- Trial name
- NCT01576016
- Testing
- Accent MRI system (lead safety), Accent MRI system (with MRI scan)
- Where
- 70 sites in United States, Australia and 3 more
- Volunteers
- 950 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Topera E-FIRM Registry
This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation.
- Trial name
- NCT02386345
- Where
- 9 sites in Germany, Netherlands
- Volunteers
- 299 people
- Sponsor
- Abbott Medical Devices
Angina, Coronary Occlusion
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and…
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis
- Trial name
- NCT01721096
- Testing
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Topera C-FIRM Registry
This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial…
- Trial name
- NCT02407249
- Where
- 9 sites in Germany, Netherlands
- Volunteers
- 73 people
- Sponsor
- Abbott Medical Devices
Atrial Septal Defect
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
- Trial name
- NCT00650936
- Testing
- AMPLATZER Septal Occluder
- Where
- 51 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Heart Septal Defects, Ventricular
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with…
- Trial name
- NCT00583791
- Testing
- Device closure with the AMPLATZER Muscular VSD Occluder
- Where
- 11 sites in United States
- Volunteers
- 91 people
- Sponsor
- Abbott Medical Devices
Angioplasty, Chronic Coronary Occlusion
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to: Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort…
- Conditions
- Angioplasty, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease
- Trial name
- XV CHINA SAS (NCT01249027)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Where
- United States
- Volunteers
- 2,605 people
- Sponsor
- Abbott Medical Devices