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NCT ID: NCT06261788 Completed - Valve Heart Disease Clinical Trials

Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

This is a prospective, single-center, non-randomized open label study. The objective of this study is to evaluate the efficacy and safety of the Sync-AV II Temporary Cardiac Pacing Catheter in subjects whose elective surgical or interventional procedure require temporary pacing support.

NCT ID: NCT06042036 Recruiting - Clinical trials for Respiratory Insufficiency

Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure

SPIRAL
Start date: June 12, 2023
Phase:
Study type: Observational

The goal of this observational study is to estimate the prevalence of the use of protective ventilation with low tidal volume ventilation in the transition of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure in ICUs in Latin America and its association with patient outcomes. The main questions it aims to answer are: - what is the prevalence of the use of low tidal volume ventilation (VT <8 mL/kg of predicted body weight) in the first 24 hours of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure? - Is there an association between the rate of adherence to low tidal volume ventilation in spontaneous ventilation modes and the ability to stay off ventilatory support and mortality? Participants are patients with acute respiratory failure under mechanical ventilation. Investigators will collect data on the ventilatory parameters of participants - 24 hours before they begin to be ventilated with spontaneous modes of ventilation - during the first 24 hours of spontaneous ventilation Investigators will collect several patient-centered clinical outcomes at 28 days after study inclusion, including ventilator-free days and mortality

NCT ID: NCT05883462 Recruiting - Clinical trials for Chronic Rhinosinusitis

Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)

Start date: June 7, 2023
Phase: Early Phase 1
Study type: Interventional

It is a first in human (FIH) study to evaluate safety, and potential efficacy of Airiver Nasal DCB in the treatment of recurrent CRSwNP or CRSsNP. Participants will receive AIRIVER Nasal drug-coated balloon treatment.

NCT ID: NCT05791032 Active, not recruiting - Clinical trials for Ventricular Tachycardia

Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study

Start date: September 5, 2023
Phase: N/A
Study type: Interventional

STEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate the preliminary safety and performance of the Investigational Devices. The study is intended to inform the final device design which will be further evaluated in traditional feasibility and /or pivotal clinical investigations. The primary safety objective is to characterize safety of the EV-ICD Lead through 3 months post-implant. The primary performance objective is to characterize sensing and conversion of induced VF with the EV-ICD Lead up to 3 months post-implant.

NCT ID: NCT05757726 Recruiting - Clinical trials for Arteriovenous Fistula

Early Feasibility of the Velocity™ Percutaneous pAVF System

VENOS-1
Start date: February 14, 2023
Phase: N/A
Study type: Interventional

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 hemodialysis vascular access.

NCT ID: NCT05732818 Recruiting - Back Pain Clinical Trials

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3

LOPAIN3
Start date: November 4, 2022
Phase: N/A
Study type: Interventional

This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL) approach. Patients that are at least 21 years or older, presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression will be included in this study.

NCT ID: NCT05729620 Active, not recruiting - Clinical trials for End Stage Renal Disease

Evaluation of STARgraft-3 for Hemodialysis

Start date: November 29, 2022
Phase: N/A
Study type: Interventional

This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection. This study is an extension from prior studies with STARgraft AV (NCT03916731) and STARgraft-2 (NCT04783779) investigational devices. A previous study also included control implants of commercially available standard ePTFE grafts approved for the same use. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to evaluate the performance of the investigational STARgraft-3 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year. Estimated enrollment is 15 subjects in this study.

NCT ID: NCT05633394 Recruiting - Conduction Defect Clinical Trials

Subcostal Temporary Extravascular Pacing V Study

STEP V
Start date: January 23, 2023
Phase: N/A
Study type: Interventional

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 over a two-day use period with Subjects restricted to bedrest. Lead performance will also be evaluated without bedrest restrictions in the limited period shortly before lead removal on the last follow-up day.

NCT ID: NCT05508360 Recruiting - Clinical trials for Degenerative Disc Disease

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

LOPAIN2
Start date: August 22, 2022
Phase: N/A
Study type: Interventional

This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.

NCT ID: NCT05457673 Completed - Conduction Defect Clinical Trials

Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

STEP IV
Start date: August 17, 2022
Phase: N/A
Study type: Interventional

The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System to support the development of a future pivotal study with an indication limited to a maximum of 7 days.