Clinical trials: completed, sponsored by Abbott Medical Devices
Post-Infarction Ventricular Septal Defect
The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017.
- Trial name
- PIVSD PAS (NCT03165526)
- Testing
- AMPLATZER™ Post-infarct Muscular VSD Occluder
- Where
- 17 sites in United States
- Volunteers
- 131 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Sinus Node Dysfunction
LBBAP Data Collection Registry
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT05887323
- Testing
- Implantation of the Tendril 2088 lead in the LBBA
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 221 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Atrial Fibrillation
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.
- Trial name
- PAFOS (NCT01912326)
- Testing
- Pacemaker Implantation
- Where
- Germany
- Volunteers
- 249 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain
The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments.
- Trial name
- NCT02587637
- Testing
- Dorsal root ganglion (DRG) stimulation
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact…
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
- Trial name
- WAVE-MAP AF (NCT03882021)
- Testing
- A specific electrophysiology mapping protocol is applicable with the GRID catheter.
- Where
- 15 sites in Austria, Czechia and 7 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
- Trial name
- REDO-FIRM (NCT02799043)
- Testing
- Standard PVI, FIRM-Guided Procedure and PVI
- Where
- 24 sites in United States, Belgium and 2 more
- Volunteers
- 269 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
Bradycardia, Sinus Node Dysfunction
Physiologic Pacing Registry
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements…
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT03719040
- Testing
- Physiologic pacing device implant
- Where
- 50 sites in United States, Australia and 14 more
- Volunteers
- 870 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
Paroxysmal Atrial Fibrillation
LSI (Lesion Index) Workflow Observational Study
This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter…
- Trial name
- NCT03906461
- Testing
- Radiofrequency Ablation
- Where
- 9 sites in United States, Germany and 3 more
- Volunteers
- 143 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Stenosis
ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)
The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent…
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Atherosclerosis, STEMI
- Trial name
- NCT03507777
- Testing
- Coronary PCI guided by OCT, Coronary PCI guided by Angiography
- Where
- 90 sites in United States, Australia and 18 more
- Volunteers
- 2,487 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Valve Regurgitation
MitraClip NT System Post-marketing Surveillance Study - Japan
The purpose of the MitraClip 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 device, and to…
- Trial name
- MitraClip NT (NCT03500692)
- Testing
- MitraClip NT System
- Where
- 40 sites in Japan
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
ABLATOR Brazil - Ablation Observational Study (Registry)
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of St. Jude Medical (SJM)/Abbott mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).
- Trial name
- NCT03041233
- Testing
- Observation / Data Collection
- Where
- 12 sites in Brazil
- Volunteers
- 833 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.
- Trial name
- Prodigy-I (NCT02143791)
- Testing
- Burst and Tonic stimulation
- Where
- 21 sites in Australia, Belgium and 7 more
- Volunteers
- 126 people
- Sponsor
- Abbott Medical Devices
Parkinson Disease
IPG Replacement Study (PREFERENCE-H)
This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical…
- Trial name
- PREFERENCE-H (NCT02963259)
- Testing
- SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system
- Where
- 14 sites in United States, Germany and 1 more
- Volunteers
- 17 people
- Sponsor
- Abbott Medical Devices
Complex Regional Pain Syndrome (CRPS)
TARGET Post-Approval Study
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation.
- Trial name
- TARGET PAS (NCT02800863)
- Testing
- Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System), Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
- Where
- 44 sites in United States
- Volunteers
- 426 people
- Sponsor
- Abbott Medical Devices
Cardiac Resynchronization Therapy
ECGi of SyncAV With MultiPoint Pacing
The objective of this clinical study was to evaluate the impact of Multipoint Pacing (MPP) and SyncAV programming on ventricular electrical activation time and activation sequence using noninvasive electrocardiographic imaging…
- Trial name
- NCT06444386
- Testing
- MPP + SyncAV
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional…
- Trial name
- INTELLECT 2-HF (NCT03247829)
- Testing
- Hemodynamic management using CardioMEMS HF System
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Left-Sided Heart Failure
CardioMEMS HF System Post Approval Study
The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.
- Conditions
- Heart Failure, Left-Sided Heart Failure, Congestive Heart Failure
- Trial name
- NCT02279888
- Testing
- CardioMEMS HF System
- Where
- United States
- Volunteers
- 1,214 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation, Ventricular Tachycardia
Advisor HD Grid Observational Study
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 Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called…
- Trial name
- NCT03733392
- Testing
- Advisor HD Grid Mapping Catheter, Sensor Enabled
- Where
- 25 sites in Australia, Austria and 9 more
- Volunteers
- 379 people
- Sponsor
- Abbott Medical Devices