Clinical trials: active, sponsored by Abbott Medical Devices
Atrial Fibrillation (AF), Paroxysmal AF
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and…
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF, Persistent Atrial Fibrillation
- Trial name
- CLEAR (NCT07523620)
- Testing
- PVI Ablation, Left Atrial Appendage Occluder Implant
- Where
- 16 sites in Belgium, Czechia and 8 more
- Volunteers
- 240 people
- Sponsor
- Abbott Medical Devices
Paroxysmal AF, Atrial Arrhythmia
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in…
- Conditions
- Paroxysmal AF, Atrial Arrhythmia, Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- BLAST-OFF (NCT07181590)
- Testing
- Pulsed Field Ablation
- Where
- 22 sites in Austria, Belgium and 10 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrythmia
Aveir VR Coverage With Evidence Development Post-Approval Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- CED (NCT05336877)
- Testing
- Aveir VR Leadless Pacemaker System, Single-Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 8,744 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrythmia
AVEIR DR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05932602
- Testing
- Aveir DR Leadless Pacemaker System, Dual Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 2,812 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrhythmia
Aveir AR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).
- Conditions
- Cardiac Pacemaker, Arrhythmia, Bradycardia
- Trial name
- ARRIVE (NCT06100770)
- Testing
- Aveir AR Leadless Pacemaker, Single-chamber atrial transvenous pacemaker
- Where
- United States
- Volunteers
- 586 people
- Sponsor
- Abbott Medical Devices
Treatment Resistant Depression
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic…
- Trial name
- TRANSCEND (NCT06423430)
- Testing
- Active-stimulation
- Where
- 26 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Cardiac Rhythm Disorder
LEAP 2 Chronic EFS
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT07287423
- Testing
- AVEIR CSP Leadless Pacemaker System
- Where
- Czechia
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Ventricular Tachycardia
Evaluation of the DuoVT PFA System for Ventricular Tachycardia
This study is a prospective, non-randomized, single-arm, multicenter study to evaluate the safety and effectiveness of the DuoVT Pulsed Field Ablation (PFA) System.
- Trial name
- EXACT-VT (NCT07706712)
- Testing
- Ablation procedure with DuoVT PFA system
- Where
- 5 sites in Croatia, Czechia and 2 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Bradycardia
Merlin Expanded ECG NSR
This clinical investigation is a prospective, single-arm, multi-center, observational study designed to evaluate the concordance between a simplified electrocardiogram (ECG) method implemented on the Merlin™ 3650 or MER3700…
- Trial name
- NCT07877805
- Testing
- Left Bundle Branch Implant
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Ischemic Heart Disease (IHD)
A Clinical Evaluation of AMJ-401
A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan
- Trial name
- NCT07373353
- Testing
- AMJ-401
- Where
- 10 sites in Japan
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Acute Myocardial Infarction, Restenoses, Coronary
Abbott Vascular Medical Device Registry
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use…
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism
- Trial name
- AV-MDR (NCT04573660)
- Testing
- Coronary and peripheral stents, Pacing catheters, Vascular plugs
- Where
- 37 sites in United States, Australia and 12 more
- Volunteers
- 3,784 people
- Sponsor
- Abbott Medical Devices
Patent Ductus Arteriosus
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect…
- Trial name
- NCT04371081
- Testing
- Amplatzer Piccolo Occluder
- Where
- Japan
- Volunteers
- 70 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation (TR)
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved…
- Trial name
- TREAT TR (NCT07586995)
- Testing
- Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Right Ventricular Pacing
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- LBBAP PMCF (NCT07217392)
- Testing
- LBBAP lead
- Where
- 15 sites in Brazil, France and 7 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation
Cephea Early Feasibility Study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral…
- Trial name
- NCT05061004
- Testing
- Cephea Mitral Valve System
- Where
- 22 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Stenosis
Cephea South America Feasibility Study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral…
- Trial name
- NCT07244939
- Testing
- Cephea Mitral Valve System
- Where
- 3 sites in Brazil, Chile
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Stenosis
Abbott Cephea Mitral Valve Disease Registry
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation
- Trial name
- NCT07069673
- Where
- 24 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Calcification, Coronary Artery Disease
TECTONIC CAD IVL IDE Study
A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites
- Conditions
- Coronary Artery Calcification, Coronary Artery Disease, Stenotic Coronary Lesion
- Trial name
- TECTONIC (NCT06885177)
- Testing
- Experimental
- Where
- 40 sites in United States
- Volunteers
- 335 people
- Sponsor
- Abbott Medical Devices
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices