Clinical trials: sponsored by Abbott Medical Devices
Non-Valvular Atrial Fibrillation
Amplatzer Amulet China Post Market Study (PMS)
The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.
- Trial name
- NCT06189365
- Testing
- Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder
- Where
- 5 sites in China
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Advanced Heart Failure
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04915924
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 22 sites in South Korea
- Volunteers
- 358 people
- Sponsor
- Abbott Medical Devices
Atrial Arrhythmia, Atrial Fibrillation
VOLT-AF IDE Clinical Study
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™…
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NCT06223789
- Testing
- Pulsed Field Ablation
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 392 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (AF), Stoke
Abbott Medical - VERITAS Study
The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are…
- Trial name
- NCT06707688
- Testing
- Amulet™ 2 Left Atrial Appendage (LAA) Occluder
- Where
- 35 sites in United States, Belgium and 7 more
- Volunteers
- 458 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Insufficiency
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP).
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases
- Trial name
- SUMMIT (NCT03433274)
- Testing
- Tendyne Mitral Valve System, MitraClip System
- Where
- 78 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Abbott Medical Devices
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
Post-Market Clinical Follow Up Study With Navitor Valve
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
- Trial name
- VISTA Nova (NCT06008080)
- Testing
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
- Where
- 50 sites in Australia, France and 9 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Heart Failure NYHA Class II, Heart Failure NYHA Class III
CardioMEMS HF System Real-World Evidence Post-Approval Study
The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.
- Trial name
- NCT06306573
- Testing
- CardioMEMS HF System
- Where
- United States
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Acute Response to Left Bundle Branch Area Pacing With SyncAV
This clinical investigation is a prospective, single-arm, post-market, non-randomized, single-center study designed to evaluate the effectiveness of the SyncAV CRT dynamic atrioventricular (AV) delay feature when used with left…
- Trial name
- NCT06436053
- Testing
- LBBAP with SyncAV
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation (PAF)
Grid eXplore Mapping Study
The purpose of the trial is to find out if the Grid X Mapping Catheter and EnSite X EP System with EnSite X Software v3.1.1, the devices that are being studied, are safe and effective in treating Chinese patients who have atrial…
- Trial name
- NCT07421076
- Testing
- Grid X and EnSite X v3.1.1 Software
- Where
- 5 sites in China
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies
The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.
- Trial name
- CRISP (NCT02986074)
- Testing
- Paresthesia mapping lead evaluation first, Anatomical midline lead evaluation first
- Where
- 2 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Heart Diseases
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are…
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Pulmonary Hypertension
- Trial name
- TEAM-HF (NCT06526195)
- Testing
- CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System, Guideline Medical Directed Therapy
- Where
- 68 sites in United States, Austria and 6 more
- Volunteers
- 850 people
- Sponsor
- Abbott Medical Devices
Cardiac Arrythmias, Left Atrial Appendage Closure
Agilis RF TSP Early Feasibility Study
This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left…
- Trial name
- NCT07361445
- Testing
- Transseptal procedure with Agilis RF TSP System.
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
Cardiac Arrhythmias
ViewFlex X ICE First-in-Human Study
This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data…
- Trial name
- ViewFlex X FIH (NCT06772493)
- Testing
- ViewFlex X ICE System
- Where
- 8 sites in United States
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
PFO - Patent Foramen Ovale
Amplatzer PFO Occluder Post-marketing Surveillance Study
The purpose of the Amplatzer PFO Occluder 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…
- Trial name
- PFO PMS Jpn (NCT04349995)
- Testing
- Amplatzer PFO Occluder
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (AF), Atrial Arrhythmia
A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:
The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and…
- Conditions
- Atrial Fibrillation (AF), Atrial Arrhythmia, Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation
- Trial name
- FlexPulse IDE (NCT06676072)
- Testing
- PFA Ablation catheter
- Where
- 32 sites in United States, Austria and 2 more
- Volunteers
- 188 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation
Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.
- Trial name
- RESOLVE-MR (NCT04818502)
- Testing
- Tendyne™ Mitral Valve System
- Where
- 36 sites in Austria, Belgium and 11 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis
Navitor Japan Study
The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.
- Trial name
- NCT07193888
- Testing
- Navitor Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices