Clinical trials: Catheters
Paroxysmal Atrial Fibrillation
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal…
- Trial name
- AF Registry (NCT00964392)
- Testing
- Atrial fibrillation ablation
- Volunteers
- 437 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Performance of QDOT Micro™ Catheter With nGEN Generator for Patients With AFIB.
This workflow study will further evaluate the acute performance and safety of the QDOT MICRO™ catheter in a clinical setting used in combination with nGEN Generator. Subjects will be followed for 7 days post procedure.
- Trial name
- NCT04545619
- Testing
- QDOT MICRO System
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Biosense Webster, Inc.
Heart Diseases, Arrhythmia
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study
This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- AFTX (NCT00721149)
- Testing
- Radiofrequency Ablation
- Volunteers
- 10 people
- Sponsor
- Biosense Webster, Inc.
Surgical Wound
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures…
- Trial name
- NCT03573206
- Testing
- Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Cardiva Medical, Inc.
Hypertension, Renal
RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157
This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.
- Trial name
- RENABLATE-II (NCT02095691)
- Testing
- Celsius® ThermoCool® Renal Denervation
- Volunteers
- 19 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest.
- Trial name
- Tailored-AF (NCT04702451)
- Testing
- Dispersion ablation + PVI, VX1, PVI
- Where
- 26 sites in United States, Belgium and 3 more
- Volunteers
- 377 people
- Sponsor
- Volta Medical
Vascular Access Complications
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
- Trial name
- NCT01940354
- Testing
- AccuCath IV Catheter System, Conventional IV Catheter System
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Vascular Access Complication
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01943474
- Testing
- AccuCath IV Catheter Device, Conventional IV Catheter Device
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- C. R. Bard
Pulmonary Embolism, Deep Vein Thrombosis
Angel® Catheter Early Feasibility Clinical Study
The primary objective of this clinical trial is to obtain initial insights into the safety of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE) disease AND who are not receiving…
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism
- Trial name
- NCT01847196
- Testing
- Angel® Catheter
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- BiO2 Medical
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.
Contrast Enhanced Computed Tomography
Study of Effectiveness of Smaller Gauge Fenestrated Catheters for Use in IV Contrast Enhanced CT Scans
The purpose of this study is to compare multidetector computed tomography (CT) image quality following peripheral venous high pressure injection of iodinated intravenous contrast media between a 20 gauge (GA) fenestrated…
- Trial name
- ARCTR05 (NCT01772550)
- Testing
- 20GA BD Nexiva Diffusics, 18GA Conventional Catheter
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Becton, Dickinson and Company
Atrial Fibrillation
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized…
- Trial name
- ERACE (NCT01520532)
- Testing
- Magnetic Resonance Imaging (MRI)
- Where
- 7 sites in Belgium, Canada and 3 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Femoropopliteal Artery Lesions
Ranger™ and Ranger™ SL (OTW) DCB) in China
This clinical study is a prospective, non-randomized, multicenter study to demonstrate the acceptable safety and performance of angioplasty with the Ranger DCB in native femoropopliteal artery lesions.
- Trial name
- NCT02944071
- Testing
- Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
- Where
- 9 sites in China
- Volunteers
- 123 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease
The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.
- Trial name
- NCT02653456
- Testing
- RA-308 Excimer Laser and DABRA Catheter
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Ra Medical Systems
Tachycardia, Atrioventricular Nodal Reentry
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with…
- Trial name
- PS-010 (NCT00621621)
- Testing
- Freezor® Cardiac Cryoablation Catheter CryoConsole System
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Flutter
Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter
The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1 atrial flutter.
- Trial name
- BLOCk-CTI (NCT01253200)
- Testing
- Blazer® Open-Irrigated Ablation Catheter, Control Catheter
- Where
- 26 sites in United States
- Volunteers
- 302 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter
To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary arteries or bypass grafts.
- Trial name
- NCT01635881
- Testing
- Emerge™ 1.20 mm PTCA Dilatation Catheter
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation
The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating…
- Trial name
- CACAF-2 (NCT00227344)
- Testing
- RF ablation, Antiarrhythmic drugs
- Volunteers
- 129 people
- Sponsor
- Biosense Webster EMEA
No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC Placement
Assessment of the Precision of the Sherlock 3CG Tip Positioning System
Phase I determine the location of the peripherally inserted central catheter (PICC) tip upon observation of maximum p-wave amplitude Phase II determine the precision of PICC placement in the Sherlock 3CG group versus the standard…
- Trial name
- STAT-PICC (NCT01275430)
- Testing
- Sherlock 3CG, Blind Placement
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- C. R. Bard
Infection
Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients…
- Trial name
- NCT00231153
- Testing
- Omiganan 1% gel, Povidone-Iodine 10%
- Where
- 57 sites in United States, France and 2 more
- Volunteers
- 1,859 people
- Sponsor
- Cadence Pharmaceuticals