Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05101720
Other study ID # CE-AVEC 555/2021/Sper/AOUFe
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date December 31, 2022

Study information

Verified date February 2023
Source University Hospital of Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 280
Est. completion date December 31, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: - Need of a standard transvenous pacemaker or implantable cardioverter defibrillator implantations - Age > 18 years Exclusion Criteria: - Leadless pacemaker or subcutaneous ICD

Study Design


Intervention

Procedure:
Ultrasound Guided Axillary Venous Access
Direct visualization of axillary vein will be obtained with ultrasound sterile linear probe.
Fluoroscopy-Guided Axillary Venous Access
Fluoroscopic landmarks will be used and axillary venous puncture will be performed without ultrasound

Locations

Country Name City State
Italy Azienda Ospedaliero-Universitaria di Ferrara Ferrara

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days. Composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days. One month after index procedure
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 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
Not yet recruiting NCT05957315 - Mobile Cardiac Outpatient Telemetry for Unexplained Syncope 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