Clinical trials: sponsored by Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
PULSED AF Post-Approval Study
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.
- Trial name
- NCT06578104
- Testing
- PulseSelect™ PFA system
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 580 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Ventricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled…
- Trial name
- NCT07585968
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 7 sites in United States
- Volunteers
- 260 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
STOP AF First Post-Approval Study
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
- Trial name
- NCT05227053
- Testing
- Arctic Front™ Cardiac Cryoablation Catheter
- Where
- 11 sites in United States
- Volunteers
- 142 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Persistent Atrial Fibrillation
STOP Persistent AF PAS
The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
- Trial name
- NCT05005949
- Testing
- Arctic Front™ Cardiac Cryoablation Catheter System
- Where
- 17 sites in United States, Austria and 4 more
- Volunteers
- 393 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation (AF), Persistent Atrial Fibrillation
Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)
Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia.
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- Conquer-AF (NCT07298473)
- Testing
- Sphere-9 Catheter Ablation
- Where
- 30 sites in United States, Australia and 4 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
PulseSelect™ PFA Global Registry
The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.
- Trial name
- NCT06393920
- Where
- 43 sites in Australia, Belgium and 14 more
- Volunteers
- 1,950 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Affera Global Registry
The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with…
- Trial name
- NCT06026345
- Testing
- Affera Platform
- Where
- 20 sites in Austria, Belgium and 11 more
- Volunteers
- 540 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with…
- Trial name
- NEXT PULSE (NCT07575828)
- Testing
- PulseSelect Pulse Field Ablation (PFA) System
- Volunteers
- 320 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation
A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.
- Trial name
- SpherePVI (NCT05144503)
- Testing
- SpherePVI™ Catheter
- Where
- Lithuania
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.
- Trial name
- SpherePVI (NCT05115214)
- Testing
- SpherePVI™ Catheter
- Where
- 2 sites in Czechia
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Ventricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the…
- Trial name
- NCT06703489
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal AF
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives.
- Trial name
- Horizon 360 (NCT07308847)
- Testing
- Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
- Where
- 24 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation (PAF)
Sphere-9 PAF China Study
The goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have…
- Trial name
- NCT07789925
- Testing
- Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System
- Where
- 10 sites in China
- Volunteers
- 180 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
DIAMOND AF Post-Approval Study
The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial
- Trial name
- DAF PAS (NCT05230524)
- Testing
- DiamondTemp™ Ablation System
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 84 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Persistent Atrial Fibrillation
SPHERE Per-AF Post-Approval Study
SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.
- Trial name
- NCT06858306
- Testing
- Sphere-9™ Catheter and Affera™ Ablation System
- Where
- 14 sites in United States
- Volunteers
- 200 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Arrhythmia
DiamondTemp Global Registry
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.
- Trial name
- NCT04735016
- Testing
- DiamondTemp™ Ablation System
- Where
- 21 sites in Australia, Belgium and 10 more
- Volunteers
- 545 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Symptomatic Paroxysmal Atrial Fibrillation (PAF)
FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT01490814
- Testing
- Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins
- Where
- 19 sites in Czechia, France and 6 more
- Volunteers
- 769 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Persistent Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.
- Trial name
- Diamond-AFII (NCT03643224)
- Testing
- Radiofrequency Ablation
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 376 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Cryo Global Registry
Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry
- Trial name
- NCT02752737
- Where
- 163 sites in United States, Argentina and 36 more
- Volunteers
- 5,385 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Atrial Flutter
An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias
- Trial name
- NCT04210622
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- Lithuania
- Volunteers
- 16 people
- Sponsor
- Medtronic Cardiac Ablation Solutions