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Bradycardia clinical trials

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NCT ID: NCT04559945 Active, not recruiting - Bradycardia Clinical Trials

The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

Start date: November 13, 2020
Phase: N/A
Study type: Interventional

prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

NCT ID: NCT04528030 Not yet recruiting - Hypoxia Neonatal Clinical Trials

A UK Interventional Trial in Premature Infants With Apnea of Prematurity Using a Simple, Non-invasive Vibratory Device to Study the Effectiveness in Supporting Breathing and General Stability

WAVE
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Purpose of Study: Apnoea of Prematurity (AOP) is common, affecting the majority of infants born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH), which contributes to multiple pathologies, including retinopathy of prematurity (ROP), sympathetic ganglia injury, impaired pancreatic islet cell and bone development, and neurodevelopmental disabilities. Standard of care for AOP/IH includes prone positioning, positive pressure ventilation, and caffeine therapy. The objective of this device is to provide an adjunct to current AoP treatment to support breathing in premature infants by using a simple, non-invasive vibratory device placed over limb proprioceptor fibers, an intervention using the principle that limb movements facilitate breathing. Methods Used: Premature infants (27+6 - 34+6 weeks GA) with clinical confirmed weeks with diagnosis of Apnoea of Prematurity. Caffeine therapy was not a reason for exclusion. Small vibration devices were placed on one hand and one foot and activated in a 6 hour ON/OFF sequence for a total of 24 hours. Heart rate, respiratory rate, oxygen saturation (SpO2), and breathing pauses were continuously collected.

NCT ID: NCT04505228 Completed - Clinical trials for Hypertensive Heart Disease

The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and used for evaluation of treatment.

NCT ID: NCT04463121 Recruiting - Bradycardia Clinical Trials

Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06)

CS-06
Start date: August 7, 2020
Phase: N/A
Study type: Interventional

This investigation will evaluate the effect of RV pacing lead position on cardiac function and the modulation of the autonomic nervous system with Cardiac Neuromodulation Therapy (CNT) pacing signals. The study will be performed acutely prior to a pacemaker implant.

NCT ID: NCT04437901 Not yet recruiting - Atrial Fibrillation Clinical Trials

COVIDAR - Arrhythmias in COVID-19

COVIDAR
Start date: June 2020
Phase:
Study type: Observational [Patient Registry]

BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify potential modifiable predisposing factors to reduce their incidence and to inform the best arrhythmia management options in this patient population. MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the SARS-CoV2 infection. STUDY DESIGN: patient registry (observational). Patients will not undergo any additional investigations. Only data that is generated during routine clinical care will be collected. STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed COVID-19.

NCT ID: NCT04353960 Recruiting - Bradycardia Clinical Trials

The Alaska Oculocardiac Reflex Study

AK-OCR
Start date: September 1, 1992
Phase:
Study type: Observational

Observation study monitoring vital signs and anesthetic variables particularly heart rate during prospective, ocular manipulation and specifically uniform tension on extra ocular muscles during strabismus surgery. *IRB approval from 1992 covered in letter from then IRB chair Dr. Judith Whitcomb, Anchorage, Alaska (letter 10/2020).*

NCT ID: NCT04346537 Completed - Bradycardia Clinical Trials

INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

Start date: August 6, 2020
Phase:
Study type: Observational

The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.

NCT ID: NCT04327466 Completed - Clinical trials for Infant, Premature, Diseases

Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants

Osciflow
Start date: May 22, 2020
Phase: N/A
Study type: Interventional

This study evaluates the effect of non-invasive high frequency oscillations applied via a highflow nasal cannula ('Osciflow') compared to highflow nasal cannula without oscillations (HF) on desaturations and bradycardia in premature infants. It uses a crossover design. Infants are randomized to begin the study with either Osciflow or HF. Both modes are applied for 4 hours. Infants are monitored with an oximetry sensor to measure peripheral oxygen saturation (SpO2) and pulse rate, and with a transcutaneous CO2-transducer. Further measurements include respiratory rate and 'Bernese pain scale' evaluated by nursing staff and Electrical Impedance Tomography (EIT) in a subset of patients.

NCT ID: NCT04303494 Completed - Clinical trials for Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)

Predictive Value of Heart Rate Variability on Cardiorespiratory Events

Start date: July 1, 2018
Phase:
Study type: Observational

The aim of this study are to investigate whether heart rate variability (HRV) parameters derived from nonlinear time series analysis at five different time points have prognostic utility for assessing the risk of postimmunisation AOP in very preterm/very low birth weight infants immunised in the hospital.

NCT ID: NCT04253184 Active, not recruiting - Bradycardia Clinical Trials

Micra AV Transcatheter Pacing System Post-Approval Registry

Micra AV PAS
Start date: February 8, 2020
Phase:
Study type: Observational [Patient Registry]

Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.