Clinical trials: completed, sponsored by 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
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
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
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
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
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
ICD, Tachycardia
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.
- Trial name
- ASIA MRI ICD (NCT02877693)
- Testing
- Thoracic MRI Scan
- Where
- 20 sites in India, Malaysia and 1 more
- Volunteers
- 205 people
- Sponsor
- Abbott Medical Devices
Tachycardia
China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD]
This clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac resynchronization therapy defibrillators (CRT-Ds), with Durata or…
- Trial name
- CN_MRI_ICD (NCT03828357)
- Testing
- Study MRI scan
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
Chronic Total Occlusion of Coronary Artery, Vascular Disease
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and To…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Trial name
- XVU-AV DAPT (NCT01106534)
- Testing
- clopidogrel + aspirin OR prasugrel + aspirin, XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
- Where
- 144 sites in United States
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
Ischemic Heart Disease, Coronary Artery Stenosis
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention…
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis, Chronic Coronary Total Occlusion, Coronary Bypass Graft Stenosis
- Trial name
- CROSS (NCT01186198)
- Testing
- MINI TREK RX 1.20 mm Coronary Dilatation Catheter
- Where
- 4 sites in United States
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard…
- Trial name
- NCT04356040
- Testing
- TactiFlex SE, TactiFlex SE - High Standard Power
- Where
- 45 sites in United States, Australia and 8 more
- Volunteers
- 355 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
Absorb IV Randomized Controlled Trial
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- NCT02173379
- Testing
- Absorb BVS, XIENCE
- Where
- 120 sites in United States, Australia and 3 more
- Volunteers
- 2,604 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
The aim of this pre-market, prospective, single-arm, non-randomized, open-label, multi-center clinical study is to collect confirmatory data to show that the Gemini SCS neurostimulation system functions as intended in a clinical…
- Trial name
- NCT05590000
- Testing
- Gemini SCS neuromodulation system
- Where
- 6 sites in Australia
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Percutaneous Coronary Intervention
Patient Centered Machine Learning Model for Bleeding and Ischemic Risk
Dual antiplatelet therapy (DAPT) is indicated in all patients undergoing coronary stent implantation to prevent ischemic recurrencies despite an increased risk of bleeding.
- Trial name
- xDAPT (NCT06089304)
- Testing
- Percutaneous coronary intervention
- Where
- United States
- Volunteers
- 19,000 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
ABSORB III Randomized Controlled Trial (RCT)
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB-III (NCT01751906)
- Testing
- Absorb BVS, XIENCE
- Where
- 192 sites in United States, Australia
- Volunteers
- 2,008 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory…
- Trial name
- TactiSense (NCT03354663)
- Testing
- TactiCath SE
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 156 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
PROLONG Prospective, Multi-center, Open-label, Post-market Study
Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit.
- Trial name
- PROLONG (NCT03908476)
- Testing
- Burst-capable SCS system, DRG Stimulator
- Where
- 21 sites in United States
- Volunteers
- 118 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy
The purpose of this clinical study is to evaluate the safety and clinical effectiveness of use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart…
- Trial name
- LAPTOP-HF (NCT01121107)
- Testing
- Left Atrial Pressure Monitoring System, Patient Advisory Module
- Where
- 64 sites in United States, New Zealand
- Volunteers
- 486 people
- Sponsor
- Abbott Medical Devices
Arrhythmia
Perclose Multi-Access Duplex Ultrasound (DUS) Study
The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and…
- Trial name
- NCT04904809
- Testing
- Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
- Where
- 2 sites in United States
- Volunteers
- 36 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