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Pacemaker clinical trials

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NCT ID: NCT06356207 Recruiting - Syncope Clinical Trials

Syncope-Asystole Latency Time in Tilt Table Test: The SALT-TILT Study

SALT-TILT
Start date: March 20, 2024
Phase:
Study type: Observational [Patient Registry]

Syncope is a common presenting condition. Pacemaker implantation can significantly reduce syncope recurrences in reflex syncope. However, despite careful selection, a substantial proportion of patients treated with pacemakers suffer recurrences of syncope. It is thought that a pronounced vasodepressor component may hinder the efficacy of pacing in patients, preventing adequate cerebral perfusion during the reflex, thus relativizing the anti-bradycardia function of the pacemaker to prevent syncope. It is hypothesised that the time elapsed from the actual loss of consciousness to the asystole recorded on the ECG during Tilt Table Test may be predictive in terms of response to pacemaker therapy, so this parameter becomes the subject of the present study.

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 Recruiting - Heart Failure Clinical Trials

RAFT-P&A Randomized Control Trial

Start date: April 25, 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: 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: 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: NCT04931550 Recruiting - Heart Failure Clinical Trials

Clinical Study of Impact of Different Pacing Site in Patients

Start date: August 1, 2020
Phase:
Study type: Observational

At present, cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients. With the rapid development of technology, different sites can be chosen to pace, such as right atrial appendage, the atrial septum and the right atrial wall in the atrium, His bundle, left bundle branch area, right ventricular apex, outflow tract, and left ventricular pacing via coronary vein in the ventricle. There are few studies comparing the long-term efficacy and safety of different pacing sites in daily practice. This study aims to observe the efficacy and safety of cardiac pacing at different sites in short and long term, and to compare the advantages and disadvantages of pacing at different sites.

NCT ID: NCT04870424 Recruiting - Clinical trials for Transcatheter Aortic Valve Replacement

Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

Co-STAR
Start date: September 21, 2021
Phase: Phase 3
Study type: Interventional

Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical aortic valve replacement for the treatment of patients with symptomatic severe aortic stenosis. While peri-procedural complications such as stroke, vascular complications and bleeding have substantially declined with the refinement of transcatheter valves and increasing experience, new-onset atrial fibrillation (NOAF) or atrioventricular conduction disturbances continue to occur in almost half of all patients. Colchicine is a well-known substance that has been approved for the treatment of acute gout flares and familial Mediterranean fever in many countries. Colchicine has proven safe and effective in the prevention of atrial fibrillation after cardiac surgery. The anti-inflammatory effects of colchicine may mitigate the occurrence of atrioventricular conduction disturbances and thus the need for the implantation of a permanent pacemaker post transcatheter aortic valve implantation. The objective of the Co-STAR-Trial is to investigate the efficacy of colchicine for the prevention of new-onset atrial fibrillation and conduction disturbances requiring the implantation of a permanent pacemaker in patients undergoing transcatheter aortic valve implantation. Co-STAR is an investigator-initiated, randomized, double blind, placebo-controlled trial. A total of 200 patients referred for treatment of symptomatic severe aortic stenosis and selected to undergo TAVI will be randomized in a 1:1 ratio to the treatment with Colchicine or placebo for 30 days post transcatheter aortic valve implantation.

NCT ID: NCT04201015 Recruiting - Clinical trials for Heart Failure, Systolic

Optimising Pacing for Contractility 2

OPT-cont 2
Start date: June 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over and a small parallel group feasibility study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled 3-arm parallel group trial whether optimal programming versus standard rate-response programming versus no rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity and what the mechanisms of this might be. 400 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test, complete quality of life questionnaires and be offered the opportunity to participate in a series of mechanistic substudies. They will then be randomised to optimal rate-response settings, standard rate response settings or no rate-response settings and followed up at 6 months at which point the tests will be repeated.

NCT ID: NCT04051814 Recruiting - Pacemaker Clinical Trials

A Retrospective Trial to Evaluate the Micra Pacemaker

Micra
Start date: July 31, 2019
Phase:
Study type: Observational [Patient Registry]

This is a retrospective study of our patient population implanted with the Medtronic's Leadless single-chamber ventricular pacemakers.