Clinical trials: Isolation
Paroxysmal Atrial Fibrillation
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
- Trial name
- SHINE (NCT03437733)
- Testing
- Radiofrequency Ablation
- Where
- 5 sites in Czechia, Italy and 1 more
- Volunteers
- 98 people
- Sponsor
- Biosense Webster, Inc.
Multiple Sclerosis, Clinically Isolated Syndrome
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of…
- Trial name
- MINORE (NCT04998812)
- Testing
- Ocrelizumab
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
HIV-1 Infection
Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I
The primary objective of the study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) after switching from a stable regimen consisting of…
- Trial name
- NCT02616029
- Testing
- E/C/F/TAF
- Where
- 21 sites in United States, France and 3 more
- Volunteers
- 66 people
- Sponsor
- Gilead Sciences
Paroxysmal Atrial Fibrillation
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal.
- Trial name
- NCT03624881
- Testing
- Catheter ablation with EPU
- Where
- 41 sites in United States
- Volunteers
- 333 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
- Trial name
- NCT01824394
- Testing
- nMARQ Navigation Catheters, NaviStar ThermoCool Catheters
- Volunteers
- 481 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation.
- Trial name
- TOCCASTAR (NCT01278953)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Optic Neuritis
Atacicept in Subjects With Optic Neuritis
This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS.
- Trial name
- NCT00624468
- Testing
- Atacicept
- Where
- 28 sites in United States, Australia and 9 more
- Volunteers
- 34 people
- Sponsor
- EMD Serono
Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
- Trial name
- OLTERMS (NCT00595920)
- Testing
- Tovaxin
- Where
- 27 sites in United States
- Volunteers
- 116 people
- Sponsor
- Opexa Therapeutics, Inc.
Paroxysmal Atrial Fibrillation
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
- Trial name
- Q-FFICIENCY (NCT03775512)
- Testing
- RF Ablation with QDOT Micro
- Where
- 22 sites in United States
- Volunteers
- 283 people
- Sponsor
- Biosense Webster, Inc.
Thrombosis, Venous
Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.
- Trial name
- NCT00443053
- Where
- 227 sites in Bulgaria, Czechia and 15 more
- Volunteers
- 3,002 people
- Sponsor
- GlaxoSmithKline
Atrial Fibrillation, Stroke
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm.
- Trial name
- NCT00129545
- Testing
- WATCHMAN Left Atrial Appendage Closure Technology, Warfarin
- Where
- 62 sites in United States, Czechia and 1 more
- Volunteers
- 800 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Tachycardia, Supraventricular
TOCCATA - Touch+™ for Catheter Ablation
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation.
- Trial name
- TOCCATA (NCT01223469)
- Testing
- Contact force assisted irrigated RF ablation
- Volunteers
- 77 people
- Sponsor
- Abbott Medical Devices
Multiple Sclerosis
Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.
- Trial name
- ENCORE (NCT01167426)
- Testing
- Glatiramer Acetate 20 mg/0.5 mL
- Volunteers
- 148 people
- Sponsor
- Teva Neuroscience, Inc.
Growth Hormone Deficiency
Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency
The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.
- Trial name
- IGHD (NCT00630487)
- Testing
- Somatropin
- Where
- 2 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Pfizer
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
Multiple Sclerosis
Oral Cladribine in Early Multiple Sclerosis (MS)
A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome).
- Trial name
- ORACLE MS (NCT00725985)
- Testing
- Cladribine, Rebif® new formulation (RNF)
- Where
- 158 sites in United States, Argentina and 32 more
- Volunteers
- 617 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Multiple Sclerosis
REbif FLEXible Dosing in Early Multiple Sclerosis (MS)
The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension.
- Trial name
- REFLEX (NCT00404352)
- Testing
- RNF
- Where
- 67 sites in Argentina, Australia and 25 more
- Volunteers
- 517 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Automated Assessment of PVI Using a Novel EP Recording System
A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.
- Trial name
- PVISION (NCT05043883)
- Testing
- CathVision Cube® system
- Where
- 4 sites in Belgium, France
- Volunteers
- 101 people
- Sponsor
- CathVision ApS
Hypertension
A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly
Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.
- Trial name
- NCT00368277
- Testing
- Aliskiren, Ramipril, Hydrochlorothiazide
- Where
- United States
- Volunteers
- 901 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Atrial Fibrillation
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial…
- Trial name
- FARA-Free (NCT04474054)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- Croatia
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation