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Bradycardia clinical trials

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NCT ID: NCT05404204 Recruiting - Clinical trials for Coronary Artery Disease

The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy

ROTA-PACE
Start date: February 1, 2021
Phase:
Study type: Observational

Coronary artery narrowings interfere with blood flow to the heart which can cause chest pain and heart attacks. Cardiologists can treat these narrowings with balloons and stents. However, some narrowings can become very calcified and hard making treatment with balloons and stents difficult. Rotational atherectomy is a tool to treat calcific coronary disease. It uses an ablative drill to break down the hardened plaques inside the coronary arteries facilitating subsequent treatment with balloons and stents. However, during this procedure patients can experience a slow heart rate which may compromise procedural safety. Cardiologists may use a temporary pacemaker that is inserted by separately accessing the heart through a large vein usually from the leg. This maintains a safe heart rate throughout the procedure. However, inserting the temporary pacemaker is associated with additional complications. We have developed and propose an alternative strategy to provide a temporary safety pacemaker during rotational atherectomy without the need for inserting an additional pacemaker.

NCT ID: NCT05401851 Recruiting - Bradyarrhythmia Clinical Trials

Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study

LBBAP
Start date: March 24, 2022
Phase: N/A
Study type: Interventional

Study of the ventricular activation patterns during left bundle area pacing and compare it with baseline activation during normal sinus rhythm in patients with and without baseline bundle branch conduction disorder.

NCT ID: NCT05351658 Recruiting - Bradycardia Clinical Trials

Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)

TEMPACE
Start date: January 5, 2023
Phase: N/A
Study type: Interventional

Temporary cardiac pacing with active-fixation leads (TPAFL) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation. However, TPAFL requires the off-label (non-certificated) use of Pacemaker leads and generators. It is designed a fastening system to ensure the safety and efficacy of the procedure: the KronoSafe System®. The aim of this study is to demonstrate the safety and effectiveness of the KronoSafe System® for temporary pacing in a series of patients receiving TPAFL.

NCT ID: NCT05336877 Recruiting - Bradycardia Clinical Trials

Aveir VR Coverage With Evidence Development Post-Approval Study

CED
Start date: June 21, 2022
Phase:
Study type: Observational

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).

NCT ID: NCT05298748 Recruiting - Bradycardia Clinical Trials

The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants

Start date: September 16, 2022
Phase: N/A
Study type: Interventional

The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.

NCT ID: NCT05165095 Recruiting - Bradycardia Clinical Trials

Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

CALLIOPE
Start date: March 25, 2022
Phase:
Study type: Observational

The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.

NCT ID: NCT05127720 Recruiting - Bradycardia Clinical Trials

Pacemaker-based Long-term Monitoring of Sleep Apnea

ACaSA
Start date: November 30, 2021
Phase:
Study type: Observational [Patient Registry]

This is a prospective, non-interventional cohort study. It tests the hypothesis that - Pacemaker-derived monitoring of sleep-related breathing disorders and/or daily physical activity predicts clinical outcome. - Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts clinical outcome in pacemaker patients. - Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts the occurrence of AHRE in SR patients implanted with a DDDR pacemaker.

NCT ID: NCT05061862 Recruiting - Bradycardia Clinical Trials

Cardiac Implantable Electronic Device (CIED) Research Study

Start date: March 17, 2022
Phase:
Study type: Observational

The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures.

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: NCT04919733 Recruiting - Heart Failure Clinical Trials

Fluoroscopy Reduction or Elimination in CIED Implants

Start date: January 3, 2020
Phase: N/A
Study type: Interventional

CIED implants require different amounts of fluoroscopy; using 3-D mapping systems, these times could be reduced to near zero fluoroscopy. The investigators aim to describe to what extent fluoroscopy times are reduced on a routine basis on CIED implants