Clinical trials: in Paraguay
Chronic Kidney Diseases
everlinQ Endovascular Access Systems Enhancements (EASE-2) Study
Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients.
- Trial name
- NCT03708562
- Testing
- everlinQ endoAVF System
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- C. R. Bard
Coronary Artery Disease
Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
The Vascudyne Coronary Artery Bypass Study (VCAB-1) is an initial safety and feasibility study of the Vascudyne, Inc. Coronary Artery Bypass Conduit (CAB A) for bypass of stenosed native coronary arteries in patients undergoing…
- Trial name
- VCAB-1 (NCT06434935)
- Testing
- CABA
- Where
- Paraguay
- Volunteers
- 5 people
- Sponsor
- Vascudyne, Inc.
Ventricular Arrythmia, Ventricular Fibrillation
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study
The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of…
- Conditions
- Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
- Trial name
- ASCEND EV (NCT06592001)
- Testing
- Atala™ lead
- Where
- 3 sites in Croatia, New Zealand and 1 more
- Volunteers
- 19 people
- Sponsor
- AtaCor Medical, Inc.
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the…
- Trial name
- NCT02119832
- Testing
- Endovasccular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 17 people
- Sponsor
- C. R. Bard
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.
- Trial name
- NCT02119845
- Testing
- Endovascular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 16 people
- Sponsor
- C. R. Bard
Mitral Regurgitation
Feasibility Study of the Tioga TMVR System
The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR>=3+)
- Trial name
- NCT06038838
- Testing
- Tioga TMVR System
- Where
- 5 sites in Brazil, Georgia and 2 more
- Volunteers
- 30 people
- Sponsor
- Tioga Cardiovascular, Inc.
Obstructive Sleep Apnea
Assessment of OSA in Latin American and Response to Neuromod Therapy
The purpose of this study is to characterize the upper airway of Latin American subjects who have been diagnosed with moderate/severe obstructive sleep apnea (OSA) and assess response to a neuromodulation therapy to treat OSA.
- Trial name
- Trans-Q DISE (NCT06762873)
- Testing
- Drug Induced Sleep Endoscopy with PNS
- Where
- Paraguay
- Volunteers
- 50 people
- Sponsor
- Lunair Medical
Conduction Defect
Subcostal Temporary Extravascular Pacing V Study
The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System…
- Trial name
- STEP V (NCT05633394)
- Testing
- AtaCor StealthTrac Lead
- Where
- Paraguay
- Volunteers
- 29 people
- Sponsor
- AtaCor Medical, Inc.
Device Related Infection, Device Malfunction
Project My Heart Your Heart: Pacemaker Reuse
Lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in Low and Middle Income Countries (LMIC).
- Conditions
- Device Related Infection, Device Malfunction, Bradycardia
- Trial name
- MHYH (NCT04016870)
- Testing
- Reconditioned Pacemaker, New Pacemaker
- Where
- 8 sites in Kenya, Mexico and 5 more
- Volunteers
- 370 people
- Sponsor
- University of Michigan
Obstructive Sleep Apnea of Adult
Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA
ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA.
- Trial name
- ARCTIC-1 (NCT04864652)
- Testing
- CHILLS Procedure
- Where
- 2 sites in Panama, Paraguay
- Volunteers
- 84 people
- Sponsor
- Cryosa, Inc.
Degenerative Disc Disease, Chronic Low-back Pain
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
- Trial name
- LOPAIN1 (NCT04141098)
- Testing
- All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
- Where
- Paraguay
- Volunteers
- 9 people
- Sponsor
- Spinal Stabilization Technologies
Heart Failure, Acute Heart Failure (AHF)
American Registry of Ambulatory or Acutely Decompensated Heart Failure
The purpose of this study is to better characterize and understand the population of patients with ambulatory or acutely decompensated heart failure in the American continent, getting to know their sociodemographic, clinical and…
- Conditions
- Heart Failure, Acute Heart Failure (AHF), Chronic Heart Failure
- Trial name
- AMERICCAASS (NCT05295641)
- Where
- 119 sites in United States, Argentina and 19 more
- Volunteers
- 6,732 people
- Sponsor
- Fundacion Clinica Valle del Lili
Chronic Kidney Diseases, Chronic Kidney Failure
SelfWrap-Assisted Arteriovenous Fistulas
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs).
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease, End Stage Kidney Disease
- Trial name
- SW-AVF (NCT05418816)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- VenoStent
Sleep Disordered Breathing (SDB), Sleep Apnea
Neurostimulation for Sleep Disordered Breathing
This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
- Trial name
- ECLIPSE 1 (NCT06883617)
- Testing
- Neuro stimulator Implant
- Where
- Paraguay
- Volunteers
- 45 people
- Sponsor
- Lunair Medical
Anemia of Chronic Kidney Disease
Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
Phase III, multicenter, randomized, open, controlled clinical trial. A study designed as phase III, in 120 patients with chronic renal failure in the pre-dialysis stage, evaluate efficacy and safety of Hemax PFS® (PFS: prefilled…
- Trial name
- NCT04036253
- Testing
- Erythropoietin alfa
- Where
- 11 sites in Argentina, Paraguay
- Volunteers
- 43 people
- Sponsor
- Bio Sidus SA
Arteriovenous Fistula
Early Feasibility of the Velocity™ Percutaneous PAVF System
An early feasibility study of the the initial safety and efficacy of the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System when used to percutaneously create an arteriovenous fistula in patients with ESRD requiring…
- Trial name
- VENOS-1 (NCT05757726)
- Testing
- Velocity pAVF system
- Where
- Paraguay
- Volunteers
- 10 people
- Sponsor
- Venova Medical
TBI (Traumatic Brain Injury)
Pediatric Guideline Adherence and Outcomes- Argentina
Pediatric traumatic brain injury (TBI) is the leading killer of children worldwide but effective treatments for TBI are limited.
- Trial name
- PEGASUS (NCT03896789)
- Testing
- PEGASUS Program for Care
- Where
- 16 sites in Argentina, Chile and 1 more
- Volunteers
- 505 people
- Sponsor
- University of Washington
Acute Ischemic Stroke, Stroke
Early Feasibility Study of RapidPulseTM Aspiration System for Patients With Acute Ischemic Stroke
The goal of this clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 24 hours since the onset of stroke symptoms, or last…
- Conditions
- Acute Ischemic Stroke, Stroke, Large Vessel Occlusion, Mechanical Thrombectomy
- Trial name
- PULSE-C (NCT05899036)
- Testing
- RapidPulseTM Aspiration System
- Where
- 2 sites in Paraguay, Turkey (Türkiye)
- Volunteers
- 19 people
- Sponsor
- RapidPulse, Inc
Mitral Valve Insufficiency
Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
- Trial name
- NCT02607527
- Testing
- Mitral Valve IRIS Ring
- Where
- 2 sites in Brazil, Paraguay
- Volunteers
- 21 people
- Sponsor
- Boston Scientific Corporation
Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.
- Trial name
- NCT04281940
- Testing
- Transcatheter implantation of chordal repair system
- Where
- 4 sites in Georgia, Paraguay and 1 more
- Volunteers
- 7 people
- Sponsor
- Pipeline Medical