Clinical trials: sponsored by 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, Atrial Flutter
Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
- Conditions
- Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
- Trial name
- NCT04211441
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- 2 sites in Czechia
- Volunteers
- 74 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
Atrial Fibrillation
Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System.
- Trial name
- SPHERE Per-AF (NCT05120193)
- Testing
- Mapping and Ablation
- Where
- 23 sites in United States, Czechia and 1 more
- Volunteers
- 477 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Spanish Registry of Cryoballoon Ablation
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy…
- Trial name
- RECABA (NCT02785991)
- Testing
- Balloon cryoablation
- Where
- 28 sites in Spain
- Volunteers
- 1,742 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Persistent Atrial Fibrillation
Evaluation of the Phased Radio Frequency Ablation System
VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in…
- Trial name
- VICTORY-AF (NCT01693120)
- Testing
- Medtronic Phased RF Ablation System
- Where
- 40 sites in United States, Canada and 3 more
- Volunteers
- 199 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for…
- Trial name
- PULSED AF (NCT04198701)
- Testing
- Medtronic PulseSelect Pulsed Field Ablation (PFA) System
- Where
- 41 sites in United States, Australia and 7 more
- Volunteers
- 421 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
STOP Persistent AF
To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF).
- Trial name
- NCT03012841
- Testing
- Arctic Front Advance Cardiac CryoAblation Catheter
- Where
- 25 sites in United States, Canada and 1 more
- Volunteers
- 186 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Atrial Fibrillation New Onset
STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the…
- Trial name
- STOP AF First (NCT03118518)
- Testing
- Cryoablation, Antiarrhythmic drug
- Where
- 24 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Atrial Flutter
ArcticLine Feasibility Study
The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.
- Trial name
- NCT03604263
- Testing
- ArcticLine Cardiac Cryoablation Catheter
- Where
- 4 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation (PAF)
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
- Trial name
- STOP AF PAS (NCT01456949)
- Testing
- Medtronic Arctic Front® Cardiac CryoAblation System
- Where
- 39 sites in United States, Canada
- Volunteers
- 402 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Paroxysmal Atrial Fibrillation
FIRE AND ICE Re-Ablations (Retrospective Data Collection)
Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.
- Trial name
- Re-Do (NCT03314753)
- Testing
- No interventions - retrospective data collection
- Where
- 13 sites in Czechia, France and 4 more
- Volunteers
- 89 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient…
- Trial name
- NCT02433613
- Where
- 41 sites in France, Georgia and 12 more
- Volunteers
- 1,071 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.
- Trial name
- DIAMOND-AF (NCT03334630)
- Testing
- DiamondTemp Ablation catheter, TactiCath Quartz Ablation catheter
- Where
- 23 sites in United States, Canada and 3 more
- Volunteers
- 482 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia
Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study.
- Conditions
- AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia, Heart Disease
- Trial name
- NCT01426425
- Testing
- Freezor Xtra Cryoablation Catheter
- Where
- 34 sites in United States, Canada
- Volunteers
- 572 people
- Sponsor
- Medtronic Cardiac Ablation Solutions