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Pacemaker Complication clinical trials

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NCT ID: NCT06355115 Recruiting - Clinical trials for Pacemaker Complication

Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation

PACE-PRO
Start date: September 1, 2023
Phase: Phase 2
Study type: Interventional

The insertion of a permanent pacemaker (PPM) is frequently a life-saving procedure. However, the implantation process could sometimes lead to a rare but serious infection. Therefore, administering prophylactic antibiotics to prevent infections before they occur, is a useful strategy to lower the risk of such infections. Nonetheless, the optimal duration of prophylactic antibiotics for PPM remains uncertain. Individual study results are ambiguous and debatable due to the fact that each center has its own policy governing the regimen for prophylactic antibiotic use. Accordingly, the goal of this clinical trial is to assess and compare the effectiveness of two types of widely used prophylactic antibiotic durations in relation to the risk of infections following PPM implantations. The main questions it aims to answer are: 1. What is the efficacy of different durations of prophylactic antibiotics (single dosage vs 3-day dosage) in preventing infective complications following PPM implantations? 2. What factors may influence the optimum use of prophylactic antibiotics for individual patients undergoing PPM implantation to minimize the risk of infective complications? Researchers will compare a single dosage vs a 3-day dosage of prophylactic antibiotics following the PPM implantation procedure to see the risk of device-related infections. Participants will: - Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations. - Visit the clinic for follow-ups and tests.

NCT ID: NCT05761821 Recruiting - Clinical trials for Complication of Surgical Procedure

Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis

Start date: October 1, 2022
Phase:
Study type: Observational

To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.

NCT ID: NCT05667519 Recruiting - Clinical trials for Tricuspid Regurgitation

Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)

PLACE
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.

NCT ID: NCT05645978 Recruiting - Obesity Clinical Trials

Association of Obesity and Cardiovascular Outcomes in Patients With Pacemaker

Paradox
Start date: July 1, 2022
Phase:
Study type: Observational

In this study, the investigators evaluated the association between various measures of adiposity [BMI and waist circumference (WC)] and clinical outcomes in Asian patients who underwent pacemaker insertion, using a nationwide population based cohort.

NCT ID: NCT05390216 Recruiting - Infections Clinical Trials

Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement

STERILE
Start date: June 5, 2022
Phase: N/A
Study type: Interventional

Increasing number of cardiac implantable electronic devices (CIEDs) have been implanted in the worldwide every year, which is accompanied by the growing number of CIED-related infection, especially in patients with CIED replacement. This multicenter, prospective, single-blinded, randomized controlled trial is to confirm the impact of partial capsule decortication on device-related infection in patients receiving CIED replacement.

NCT ID: NCT05101720 Completed - Clinical trials for Arrhythmias, Cardiac

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

ZEROFLUOROAXI
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04945005 Completed - Clinical trials for Tricuspid Valve Insufficiency

Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry

PLACE
Start date: November 1, 2019
Phase:
Study type: Observational [Patient Registry]

Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation.

NCT ID: NCT04111354 Active, not recruiting - Clinical trials for Pacemaker Complication

Early Mobilization After Pacemaker Implantation.

EMAPI
Start date: March 28, 2019
Phase: N/A
Study type: Interventional

Permanent pacemaker implantation is one of the most common arrhythmological procedure. This procedure is usually accompanied by a minimum of 2-3 days hospitalization, with immobilization of patients (supine) for 16-24 hours. The optimal duration of patient´s immobilization is not determined. There is also no recommendation from individual manufacturers of pacemakers for the duration of immobilization after pacemaker implantation. The length of immobilization is based rather on the tradition established at the time of using electrodes with passive fixation. The aim of our prospective, randomized study (EMAPI) is to compare the safety of short-term (4-hours) immobilization with long-term (16-24 hours) immobilization after primary pacemaker implantation. Septal position will be used for right ventricular electrode.

NCT ID: NCT03475498 Recruiting - Clinical trials for Pacemaker Complication

A Major Determinant Focused on the ECG or Echocardiogram for PICM and Its Clinical Outcome (PICM Syndrome)

Start date: March 1, 2018
Phase:
Study type: Observational [Patient Registry]

Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM). Several parametes make difference of effect on the occurrence of PICM and its subsequent clinical outcomes. In particular, recognition of a major determinant focused on the ECG or echocardiographic parameters including strain or genetic factor for occurrence of PICM may lead to better identification of patients at high risk. Investigators prospectively enroll a participant with documented high risk of PICM and clinically follow-up to idenify clinical impact of PICM (PICM syndrome) over a long period of time.

NCT ID: NCT03148444 Not yet recruiting - Clinical trials for Infection, Bacterial

Impact of Antibiotic Treatment Following Implantation of Cardiac Electronic Device on Patient's Outcome

Start date: June 1, 2017
Phase: Phase 4
Study type: Interventional

Background: Infection of cardiac implantable electronic device including wound and pouch infection, bacteraemia and endocarditis is a common complication of device insertion. The role of antibiotic prophylaxis in prevention of this complication is well established. Most centres in Israel currently prescribe antibiotics about 5 days following the procedure as well, though clear clinical evidence warranting this practise is lacking. Unnecessary antibiotic treatment can lead to adverse events including allergy, undesirable effects of the antibiotics, establishment of resistance to antibiotics among bacteria and further infections with resistant strains. Objective: The investigators hope to either establish evidence warranting use of post-procedural antibiotic treatment or refuting it. Methods: The investigators intend to recruit about 400 patients a year into both trial group and control group. The trial group will be treated with post-procedural antibiotics during 5 days, while the control group will receive no post-procedural antibiotics. The endpoints of the study will include infections related to the implantable device and proposed adverse effects of the antibiotics. The t-test will be performed in order to evaluate whether benefit exists concerning one of the groups.