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Pacemaker clinical trials

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NCT ID: NCT06330675 Recruiting - Pacemaker Clinical Trials

Correct Mobilization Time After CIED Implantation: A Single-centre, Open-label, Non-inferiority RCT

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

Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication. Due to the lack of guidelines available on the timing of postoperative mobilization management, the aim of the study is to evaluate the safety of early mobilization, comparing mobilization at 4-h against day-after procedure.

NCT ID: NCT06299514 Not yet recruiting - Heart Failure Clinical Trials

RAFT-P&A Randomized Control Trial

Start date: March 10, 2024
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker. A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy.

NCT ID: NCT06272344 Recruiting - Pacemaker Clinical Trials

Remote Programming of Cardiac Implantable Electronic Devices 2

REACT 2
Start date: April 24, 2023
Phase: N/A
Study type: Interventional

Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full CIED check-up and reprogramming is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. In this study we aim to evaluate our previously validated remote programming solution (REACT study, NCT05366660) in outpatient device clinics which are close to the patient's home but remote from the CIED expert.

NCT ID: NCT06262295 Not yet recruiting - Pacemaker Clinical Trials

National, Observational Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France (France LEADLESS)

Start date: February 2024
Phase:
Study type: Observational [Patient Registry]

Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not developed until the late 2010s. Leadless pacemakers can also improve patient comfort by replacing surgery with a percutaneous procedure, eliminating the mass and scar visible at the implantation site of a conventional pacemaker, and eliminating the need for activity restrictions to prevent dislodgement after implantation of a conventional lead. The AVEIR VR LP leadless pacemaker was CE marked in July 2023 and will be implanted in patients in Europe. The objective of this national registry is to evaluate the safety and performance of the AVEIR VR LP system in a population of patients indicated for implantation of a VVI(R) pacemaker in France. This registry will also allow the collection of patient characteristics and indications under normal conditions of use.

NCT ID: NCT05993585 Recruiting - Pacemaker Clinical Trials

The Effect of CRT on the Frank Starling Mechanism

CRT
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The investigators are examining a scientific principle called the Frank Starling Mechanism and how it relates to Cardiac Resynchronisation Therapy (CRT), a form of pacemaker therapy used in the treatment of heart failure. The Frank Starling Mechanism is an established biological principle. The law states that the stroke volume of the heart increases in response to an increase in the volume of blood in the ventricles, before contraction, when all other factors remain constant. In other words, the law states that the more blood enters the heart, the more blood is pumped out of the heart with any given beat. There is some evidence that in some patients with chronic heart conditions, the Frank Starling Mechanism is LESS EFFECTIVE, meaning that the heart is less able to cope with a reduction in heart pumping function over time. There is also evidence that treatment with CRT may IMPROVE the Frank Starling Mechanism - evidence for this has been shown in dog and mice hearts, however, has never been shown in humans. The investigators aim to conduct a study where subjects undergo an ultrasound scan of the heart (echocardiogram) whilst the participants pacemaker settings are temporarily changed. This allows the investigators to measure the pumping function of the heart as more blood enters the heart. The investigators will perform this test on 20 participants before and after CRT, as well as 20 participants who have pacemakers, but no heart failure. This study aims to test 3 hypotheses. 1. In participants with pacemakers, a REDUCED Frank Starling Mechanism predicts which participants go on to develop heart failure. 2. Treatment with CRT IMPROVES the Frank Starling Mechanism in participants with pacemakers and heart failure. 3. The degree of improvement of the Frank Starling Mechanism after treatment with CRT predicts which participants will respond to this treatment.

NCT ID: NCT05623527 Recruiting - Stroke Clinical Trials

Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants

SOS-CARE
Start date: November 20, 2022
Phase:
Study type: Observational

Objective: To investigate the incidence, clinical characteristics and prognosis of acute ischemic and hemorrhagic cerebrovascular disease secondary to the implantation of cardiovascular implantable electronic devices, so as to provide a basis for subsequent treatment strategies and risk factor stratification. Methods: This study intends to retrospectively collect the incidence and case characteristics of acute cerebral infarction, cerebral embolism, transient ischemic attack and cerebral hemorrhage in CIED patients admitted to the First Affiliated Hospital of Xi 'an Jiaotong University and other centers from January 2012 to September 2022. Then, the incidence of poor prognosis and related factors of patients within 3 months were followed up by telephone to provide a basis for subsequent treatment strategy and risk factor stratification.

NCT ID: NCT05361681 Active, not recruiting - Pacemaker Clinical Trials

EMI and CIED: Is High Power Charging of Battery Electric Car Safe?

eCarII
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

It is not known if the use of high power charging systems for electric vehicles may interfere with the functionality of implanted pacemakers and cardioverter-defibrillators.

NCT ID: NCT05197660 Completed - Surgery Clinical Trials

Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study

Start date: January 1, 2019
Phase:
Study type: Observational

Determine the consequences of COVID-19 pandemic on routine targeted surgeries. Five surgical procedures were considered : cataract surgery, hip and knee arthoplasties, coronary revascularisation by angioplasty and definitive cardiac stimulation. The objective of the study is to quantify changes of these procedures in 2020 and in 2021 (up to June) compared to 2019 taking into account their annual evolution and according to the type of operation (primary or reoperation/revision) and emergency status, if applicable.

NCT ID: NCT05072119 Recruiting - Pacemaker Clinical Trials

Monaldi Hospital Rhythm Registry

Start date: January 7, 2015
Phase:
Study type: Observational [Patient Registry]

The study is a prospective registry. Consecutive patients with indications of implant / replacement or upgrade of pacemaker (PM), implantable cardioverter defibrillator (ICD), Implanted loop recorder (ILR) will be enrolled. The primary objective of the study is to describe the clinical events during a long-term follow-up of non-selected population of patients implanted with an PM, ICD or ILR.

NCT ID: NCT05015075 Completed - Bradycardia Clinical Trials

Cardiac Rehabilitation After Pacemaker Implantation

Start date: April 10, 2018
Phase: Phase 4
Study type: Interventional

The investigators assessed whether short-term cardiac rehabilitation following pacemaker implantation was enough to improve both physical function and quality of life.