Clinical trials: sponsored by 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
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip…
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure
- Trial name
- COAPT (NCT01626079)
- Testing
- MitraClip System
- Where
- 86 sites in United States, Canada
- Volunteers
- 776 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease
Trifecta™ Durability Study
The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve.
- Trial name
- NCT01256710
- Testing
- Trifecta™ aortic bioprosthesis
- Where
- Germany
- Volunteers
- 1,151 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
Chronic Intractable Pain
The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain (TRU-BURST)
The purpose of this prospective, multi-center, randomized, triple-blind, sham-controlled study with parallel economic evaluation is to test the analgesic superiority of BurstDR-SCS compared to sham stimulation using both…
- Trial name
- NCT06030284
- Testing
- BurstDR-SCS
- Where
- 5 sites in Canada, United Kingdom
- 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
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
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
Coronary Artery Disease, Ischemic Heart Disease
Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial
This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease, Non ST Segment Elevation Myocardial Infarction
- Trial name
- ECLIPSE (NCT03108456)
- Testing
- Orbital Atherectomy, Balloon
- Where
- 104 sites in United States
- Volunteers
- 2,005 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
Parkinson Disease
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
The purpose of the ROAM-DBS study is to compare the time needed to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the ADROIT initial programming visit in…
- Trial name
- ROAM-DBS (NCT05269862)
- Testing
- Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature, Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)
- Where
- 18 sites in United States, Germany and 2 more
- Volunteers
- 100 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
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
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, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices