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Atrioventricular Block clinical trials

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NCT ID: NCT06324682 Recruiting - Atrial Fibrillation Clinical Trials

ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing

TREEBEARD
Start date: January 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated. Participants [patients over 18 years old with an indication to receive a definitive pacemaker/intracardiac defibrillator implant] will receive a permanent cardiac pacing implant as requested according to European Society of Cardiology (ESC) guidelines; the investigators will evaluate procedural efficacy and safety of different implantation approaches.

NCT ID: NCT06197503 Recruiting - Clinical trials for Transcatheter Aortic Valve Implantation

Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI

PHYSTAVIII
Start date: November 30, 2023
Phase: N/A
Study type: Interventional

Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.

NCT ID: NCT05910866 Recruiting - Heart Failure Clinical Trials

LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy

LEAP-CAR
Start date: June 10, 2023
Phase: N/A
Study type: Interventional

LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant for advanced (2° or 3° degree) atrioventricular block, with baseline left ventricular ejection fraction (LVEF) >45%. LEAP-CAR is a randomized, prospective, double blind clinical trial.

NCT ID: NCT05856799 Recruiting - AV Block Clinical Trials

Danish Randomized Trial on Leadless vs Transvenous Pacing

DANVERS
Start date: August 25, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block. Consecutive patients with high-grade atrioventricular black and preserved sinus node function with indication for permanent pacemaker implantation according to the latest european guidelines, are included in a prospective, partly patient and accessor blinded and partly open label, 1:1 randomized combined parallel and cross-over trial to implantation with 1) a Micra AV Transcathter Pacing System or 2) an Azure XT DR dual chamber pacemaker.

NCT ID: NCT05774262 Recruiting - Clinical trials for Atrioventricular Block

Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block

TELE-SPACER
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The TELE-SPACER study is a multicenter, noncommercial, physician-initiated, proof-of-concept, prospective, randomized, controlled, unblinded clinical trial and registry designed to compare two methods of treatment of patients with functional Atrio-Ventricular Block (AVB): the guidelines-recommended elective pacemaker (PM) therapy vs cardiovascular autonomic tests (CAT), electrophysiologic assessment (EPS) with referral to cardioneuroablation (CNA) and reevaluation of indications for PM therapy. The main questions TELE-SPACER aims to answer are: - Can the investigators successfully treat functional AVB without implantable device (PM)? - Can the investigators prove the feasibility and safety and demonstrate non-inferiority of CNA procedure in patients with functional AVB, avoiding long-term permanent pacing, its limitations, complications and costs ? The TELE-SPACER trial will validate the European Society of Cardiology (ESC) recommendations (level C of evidence: expert opinion) for elective PM implantation and will introduce CNA as effective treatment in the functional AVB patient population. Functional AVB - defined as a persistent or paroxysmal AVB with a positive results of atropine test

NCT ID: NCT05722379 Recruiting - Clinical trials for AVB - Atrioventricular Block

Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block

Start date: January 1, 2023
Phase:
Study type: Observational

Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. In this study, the investigators aim to conduct a comparison of the safety and effectiveness performance between these two pacing methods for patients with atrioventricular block (AVB). The investigators focused on AVB patients undergoing permanent pacemaker implantations from the 1st of January 2018 to the 18th of November 2021 at West China Hospital.

NCT ID: NCT05714579 Recruiting - Clinical trials for Aortic Stenosis, Severe

Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block

TAVHIS
Start date: May 30, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)

NCT ID: NCT05585411 Recruiting - Clinical trials for Atrioventricular Block

PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial

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

PROTECT-SYNC study is a multicenter, randomized, controlled trial. A total of 7 medical centers across Republic of Korea will enroll 450 patients during 2 years of enrollment period, and followed for 2 years of follow-up period. The purpose of this study to compare the clinical outcomes of Left Bundle Branch Area Pacing (LBBAP) compared to Right Ventricular Pacing (RVP) in bradyarrhythmia patients who require high burden of ventricular pacing (>40%).

NCT ID: NCT05575557 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment

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

With the aging of society, the use of cardiac pacing in patients with irreversible bradycardia is increasingly widespread. As early as the 1950s, right ventricular pacing (RVP) began to be used in patients with atrioventricular block or sick sinus syndrome, but in fact such pacing could cause ventricular asynchrony, which could lead to long-term myocardial perfusion injury, valvular regurgitation, heart failure, and increased risk of ventricular tachycardia and ventricular fibrillation. The latest guideline recommended reducing the proportion of right ventricular pacing. Additionally, in patients with heart failure with reduced ejection fraction (EF ≤ 35%) and complete left bundle branch block, cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) has been recommended to improve cardiac function, but only about 30% of patients benefit from it, which may be related to poor left ventricular pacing site and myocardial scarring. In theory, His bundle pacing (HBP) compared with RVP can reduce the risk of functional tricuspid regurgitation when the lead position lies on the atrial side of the tricuspid valve, which may improve the right heart function and pulmonary artery pressure. In 2021, Domenico Grieco et al. explored the effect of HBP on right heart function. After 6 months of follow-up, it was found that HBP improved right heart function and pulmonary artery pressure compared with RVP. At present, there are few discussions on the effect of physiological pacing on right ventricular hemodynamics, and the sample size is small. Internationally, the discussion of the assessment of hemodynamics is limited to non-invasive evaluation (such as echocardiography, ECG, SPECT) The gold standard for right heart hemodynamics evaluation is the measurement of invasive right heart catheterization, and there has been no relevant research so far, so the investigators further designed a study of the effect of physiological pacing on hemodynamics.

NCT ID: NCT05541679 Recruiting - Clinical trials for Aortic Valve Stenosis

Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement (Left Bundle BRAVE)

Start date: December 28, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the superiority of chronic left bundle branch area pacing compared to traditional right ventricular (RV) septal pacing in patients with high-grade conduction disease after transcatheter aortic valve replacement (TAVR). In this investigator initiated, multicenter, prospective, double-blinded, crossover study, chronic left bundle branch area pacing will be compared to chronic right ventricular septal pacing using echocardiographic measures of left ventricular systolic function in patients with a high cumulative ventricular pacing burden after TAVR.