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.
Coronary Chronic Total Occlusions, Ischemic Heart Disease
Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures
This is a study to evaluate the safety and effectiveness of the Acolyte Catheter System used in CTO-PCI procedures. The system will be used for the placement and positioning of guidewires and catheters in the coronary vasculature…
- Conditions
- Coronary Chronic Total Occlusions, Ischemic Heart Disease, Ischemic Heart Disease (IHD), Ischemic Heart Disease Chronic
- Trial name
- NCT06795763
- Testing
- CTO-PCI Procedure with Acolyte Catheter System
- Where
- 5 sites in United States
- Volunteers
- 115 people
- Sponsor
- Elumn8 Medical
Atrial Fibrillation
High Intensity Focused Ultrasound (HIFU) Ablation System Study
The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic…
- Trial name
- NCT00392106
- Testing
- propafenone, flecainide, dofetilide
- Where
- 21 sites in United States, Czechia
- Volunteers
- 240 people
- Sponsor
- ProRhythm, Inc.
Hemodialysis
Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application
The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters…
- Trial name
- ABBA (NCT00621114)
- Testing
- GamCath® central venous catheter, GamCath Dolphin® Protect central venous catheter
- Where
- Germany
- Volunteers
- 69 people
- Sponsor
- Vantive Health LLC
Peripheral Arterial Disease
Cardiac Positioning System in Peripheral Angioplasty Procedure.
This clinical investigation is intended to evaluate the ability of a magnetic cardiac positioning system to decrease medical radiation exposure on a peripheral angioplasty procedure in patients with a peripheral artery stenosis.
- Trial name
- MDG-Periph (NCT03585387)
- Testing
- Navigation
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- Abbott Medical Devices
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.
Peripheral Intavenous Catheter Stabilization
Prospective Healthy Volunteer Study of the Securis™ Stabilization Device
This study is being conducted to assess the performance of the Securis™ Stabilization Device in simulated clinical use.
- Trial name
- NCT04841330
- Testing
- Securis™ Stabilization Device
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Becton, Dickinson and Company
Comfort and Performance of Intermittent Catheter
A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters
To evaluate the performance of GentleCath Glide™ Intermittent Catheters
- Trial name
- NCT03387878
- Testing
- Intermittent Catheter
- Where
- Poland
- Volunteers
- 39 people
- Sponsor
- ConvaTec 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.
Mitral Regurgitation
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
- Trial name
- EMBRACE (NCT07409285)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- HighLife SAS
Intracranial Atherosclerotic Stenosis
Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter
This test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of Biolimus coating.
- Trial name
- NCT06140550
- Testing
- Drug balloon dilated, balloon dilated
- Volunteers
- 204 people
- Sponsor
- Bochang
Functional Mitral Regurgitation
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.
- Trial name
- NCT05988450
- Testing
- SQ-Kyrin Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
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.
Coronary Artery Stenosis
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family
The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
- Trial name
- NCT05536180
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Arthesys
Acute Decompensated Heart Failure
DORAYA-HF OUS Assessment of the Doraya Catheter for the Treatment of ADHF Patients With Insufficient Response to Diuretics
The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.
- Trial name
- NCT05876078
- Testing
- Doraya catheter
- Where
- 10 sites in Germany, Italy and 3 more
- Volunteers
- 25 people
- Sponsor
- Revamp Medical Ltd.
Hydrocephalus
Guided Application of Ventricular Catheters
Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can…
- Trial name
- GAVCA (NCT01811589)
- Testing
- Thomale-Guide, Free-hand
- Where
- 9 sites in Germany
- Volunteers
- 144 people
- Sponsor
- Aesculap AG
Patients in Need for Intravenous Access
Evaluation of Introcan Safety 3 Closed IV Catheter
Incidence and time of occurrence of blood leakage with the closed intravascular catheter Introcan Safety 3 in comparison to Introcan Safety
- Trial name
- NCT02197013
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- B. Braun Melsungen AG
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
Acute Ischemic Stroke
Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy
Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke
- Trial name
- iNFLOW-5 (NCT07571954)
- Testing
- Thromboaspiration catheter
- Where
- 7 sites in France, Spain
- Volunteers
- 45 people
- Sponsor
- iVascular S.L.U.