Clinical trials: sponsored by Abbott Medical Devices
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR
The COAPT Continued Access Study (CAS) is an extension of the COAPT RCT under the same IDE (G120024). COAPT CAS was a single-arm, prospective, multicenter continued access registry that enrolled heart failure patients with…
- Trial name
- COAPT CAS (NCT07227675)
- Testing
- MitraClip® NT System
- Where
- 32 sites in United States
- Volunteers
- 162 people
- Sponsor
- Abbott Medical Devices
Peripheral Artery Disease
Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified…
- Trial name
- KAIZEN (NCT05529472)
- Testing
- Peripheral Orbital Atherectomy System (OAS)
- Where
- 12 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Valvular Heart Disease, Aortic Valve Disease
Regent China Post-Market Clinical Follow-up Study
Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.
- Trial name
- NCT05330468
- Testing
- Abbott Mechanical Heart Valve (MHV) Regent™
- Where
- 5 sites in China
- 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
Heart Failure, Left Bundle-Branch Block
Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block
This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and…
- Trial name
- MAP HIS HF (NCT03803995)
- Testing
- Mapping and Pacing the His Bundle, Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Stroke
Amulet™ ADVANCE LAA
This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- NCT05997446
- Testing
- Left atrial appendage occlusion (LAAO)
- Where
- 16 sites in United States
- Volunteers
- 610 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation
TriClip CED RWE Study
This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair…
- Trial name
- TRICARE (NCT06920745)
- Testing
- The TriClip System
- Where
- United States
- Volunteers
- 2,200 people
- Sponsor
- Abbott Medical Devices
Multi Vessel Coronary Artery Disease, STEMI
Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI
The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR) can be considered a prognostic predictor for the occurrence of events at one year of follow up after primary Percutaneous Coronary…
- Trial name
- AMICRO (NCT02325973)
- Testing
- PressureWire Certus guidewire
- Where
- 14 sites in Italy
- Volunteers
- 242 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Heart Failure, Systolic
Hemodynamic-GUIDEd Management of Heart Failure
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for…
- Conditions
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure NYHA Class II
- Trial name
- GUIDE-HF (NCT03387813)
- Testing
- CardioMEMS™ HF System
- Where
- 129 sites in United States, Canada
- Volunteers
- 2,358 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Tachycardia, Ventricular
Optisure Lead Post Approval Study
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.
- Trial name
- NCT02235545
- Testing
- St. Jude Medical Optisure Lead
- Where
- 60 sites in United States, Belgium and 5 more
- Volunteers
- 1,735 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic…
- Trial name
- PORTICO-IDE (NCT02000115)
- Testing
- Portico transcatheter aortic valve, Commercially available transcatheter aortic valve
- Where
- 70 sites in United States, Australia
- Volunteers
- 1,242 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation
Expanded Clinical Study of the Tendyne Mitral Valve System
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II…
- Trial name
- NCT02321514
- Testing
- Tendyne Mitral Valve System
- Where
- 40 sites in United States, Australia and 8 more
- Volunteers
- 191 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
Bradycardia
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.
- Trial name
- NCT02030418
- Testing
- Leadless Pacemaker
- Where
- 59 sites in United States, Australia and 1 more
- Volunteers
- 952 people
- Sponsor
- Abbott Medical Devices
Arterial Thrombosis
JETi Lower Extremity Arterial Thrombosis
The JETi Registry is a prospective, single-arm, multi-center study to collect real-world data on the safety, performance, and clinical benefits of the JETi™ Hydrodynamic Thrombectomy System (JETi System) for the treatment of…
- Trial name
- JETi (NCT04370691)
- Testing
- JETi lower extremity arterial thrombosis
- Where
- 30 sites in United States, Australia and 2 more
- Volunteers
- 129 people
- Sponsor
- Abbott Medical Devices
Indications for VVI(R) Pacemaker
The LEADLESS Observational Study
The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.
- Trial name
- NCT02051972
- Testing
- Implanted with a Nanostim leadless pacemaker system
- Where
- 32 sites in Czechia, France and 5 more
- Volunteers
- 491 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Cardiac Output
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE
The investigation will enroll subjects who have been previously implanted with the CardioMEMS™ Pulmonary Artery Sensor. This clinical investigation is twofold; in the first phase (development phase) data collected will be used to…
- Trial name
- VICTOR (NCT05428384)
- Testing
- MRI/ CardioMEMS comparison
- Where
- 8 sites in United States
- Volunteers
- 89 people
- Sponsor
- Abbott Medical Devices
Ventricular Arrythmia
Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.
- Trial name
- EFICAZ (NCT03632057)
- Testing
- Fixed Tilt (65%), Fixed Pulse Width
- Where
- 2 sites in Spain
- Volunteers
- 779 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Cardiac Rhythm Disorder
AVEIR Remote Care System Non-Significant Risk Study
The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP…
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT06542133
- Testing
- AVEIR remote care system
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Heart Failure
The ARIES HeartMate 3 Pump IDE Study
Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus…
- Trial name
- NCT04069156
- Testing
- LVAD Implant, Aspirin 100mg
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 628 people
- Sponsor
- Abbott Medical Devices