Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for

Status Completed

Clinical Trial Summary

Single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable cardioverter-defibrillator implantations.

Clinical Trial Description

Rationale: axillary, cephalic and subclavian venous accesses are commonly used in pacemaker and implantable cardioverter defibrillator implantations. Axillary puncture and cephalic vein surgical cutdown are both recommended in international guidelines due to low risk of pneumothorax and chronic lead complications. Sometimes cephalic vein is not available. Today axillary puncture is performed under fluoroscopic view and some complications still exist with this venous access as pneumothorax and arterial puncture. Axillary vein direct visualization can be obtained with standard venography or with ultrasound. With direct visualization and puncture of the axillary vein under ultrasound guidance venography with radiocontrast could be avoided. Less radiation exposure for patient and operator and direct visualization of the needle are possible with lower periprocedural complications using ultrasound. Despite the great interest for ultrasound guided axillary puncture up today we have few data on its feasibility. Our hypothesis is that ultrasound guided axillary access is more safe and more feasible than the standard fluoroscopic technique. We decided to enroll all the patients undergoing standard transvenous pacemaker or cardioverter implantable defibrillator. We randomize the patients with 1:1 fashion to axillary venous access under fluoroscopic guidance or to ultrasound guided axillary venous access. Obiectives: to asses safety, feasibility of the ultrasound guided venous puncture. Main Endpoint: composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05101720
Study type	Interventional
Source	University Hospital of Ferrara
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2021
Completion date	December 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03079726` - Use of Device Data to Predict Frailty in Individuals
Recruiting	`NCT06014996` - Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.	N/A
Recruiting	`NCT04092985` - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed	`NCT05404789` - Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia	N/A
Recruiting	`NCT04554160` - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Recruiting	`NCT04471584` - Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors	N/A
Recruiting	`NCT02906189` - Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices	N/A
Completed	`NCT02550340` - Munich Study for Beer Related ECG Change Workup	N/A
Completed	`NCT02466633` - Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias	N/A
Completed	`NCT01871090` - Remote Device Interrogation In The Emergency Department	N/A
Completed	`NCT04884100` - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening	N/A
Withdrawn	`NCT04556240` - RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
Active, not recruiting	`NCT05481359` - AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.
Recruiting	`NCT05047835` - Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients
Not yet recruiting	`NCT05957315` - Mobile Cardiac Outpatient Telemetry for Unexplained Syncope	N/A
Not yet recruiting	`NCT05974306` - Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System	N/A
Completed	`NCT06260670` - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation	N/A
Active, not recruiting	`NCT04876963` - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Completed	`NCT04943354` - Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure	N/A
Recruiting	`NCT03857711` - Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL — ZEROFLUOROAXI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms