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Pacemaker clinical trials

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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: 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.

NCT ID: NCT04958369 Completed - Pacemaker Clinical Trials

Ultrasound-guided Axillary Versus Conventional Cephalic Venous Access for Implantation of Cardiac Devices

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

The implantation of cardiac electronic devices is a common procedure in the Electrophysiology Laboratory. The most commonly used venous access sites are the cephalic, the axillary and the subclavian vein. Studies comparing these options have been conducted in the past. Axillary venous access can be achieved either through axillary vein angiography or by ultrasound guidance. Nevertheless, appropriate training is required for the ultrasound-guided axillary puncture technique-as well as for the cephalic vein cutdown technique. Data from randomized trials regarding direct comparison of the two methods in terms of efficacy and safety are very limited. The purpose of the study is the comparison of the efficacy and safety of the ultrasound-guided axillary venous access technique versus the cephalic venous access using the cut-down technique in patients requiring intravenous cardiac device (single-chamber/dual-chamber pacemaker/defibrillator) implantation.

NCT ID: NCT04721314 Completed - Clinical trials for Diastolic Dysfunction

Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction

myPACE
Start date: July 17, 2019
Phase: N/A
Study type: Interventional

Recent exploratory studies suggest that pacemaker patients with diastolic dysfunction (DD) or heart failure with preserved ejection fraction (HFpEF) may benefit from a higher backup heart rate (HR) setting than the factory setting of 60 beats per minute (bpm). In this prospective double-blinded randomized controlled study, pacemaker patients with DD or overt HFpEF and either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing will be enrolled and randomized to either a personalized lower HR setting (myPACE group, based on a height-based HR algorithm) or to the standard 60bpm backup setting (control group) for 1 year.

NCT ID: NCT04649788 Completed - Pacemaker Clinical Trials

Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices.

Start date: July 17, 2020
Phase: N/A
Study type: Interventional

Venous access is a fundamental step in lead insertion for endovenous cardiac implantable electronic devices (CIED). Cephalic vein cutdown is the most widely used technique in Europe. Ultrasound-guided axillary vein access is a promising alternative but there is a lack of clinical evidence supporting this technique. The purpose of this study is to compare the efficacy and safety of ultrasound-guided axillary vein access versus cephalic venous cutdown for implantation of endovenous CIED. Half of patients is implanted using an ultrasound-guided axillary vein puncture. The other half is implanted using a cephalic vein cutdown. After venous access is achieved, implantation procedure is identical in the two arms.

NCT ID: NCT04023890 Completed - Pacemaker Clinical Trials

Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients

Start date: January 14, 2019
Phase:
Study type: Observational

This is a prospective, single-site, non-randomized, acute feasibility clinical study. The purpose of this study is to explore the electrocardiogram (ECG) characteristics of simultaneous stimulation of right and left bundle branches area.

NCT ID: NCT03847298 Completed - Physical Activity Clinical Trials

Evaluation of Physical Fitness and Physical Activity Levels of Pediatric Arrhythmia Patients With Pacemaker

Start date: November 19, 2017
Phase:
Study type: Observational

The aim of this study was to evaluate physical fitness and physical activity levels of pediatric arrhythmia patients with pacemaker compared with their healthy peers.

NCT ID: NCT03843242 Completed - Heart Failure Clinical Trials

Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker

LEADER
Start date: May 30, 2019
Phase: N/A
Study type: Interventional

The recent study using IRSplus and VpS algorithm from Biotronik pacemaker showed the significant reduction in ventricular pacing to less than 3%. The purpose of this study is to evaluate the efficacy of IRSplus and VpS algorithm in reducing ventricular pacing compared with conventional DDD pacing with a fixed AV delay.

NCT ID: NCT03501355 Completed - Pacemaker Clinical Trials

Effects of Inspiratory Muscle and Endurance Training in Heart Failure Patients With Pacemaker

Start date: April 20, 2018
Phase: N/A
Study type: Interventional

It is well-known that not only peripheral muscles, but also respiratory muscles muscle weakness and deconditioning play an important role in low exercise capacity of patients with Heart Failure (HF). Exercise training has been shown to improve exercise tolerance and quality of life in patients with heart disease. However, hearth failure patients with pacemaker such as implantable cardioverter defibrillators (ICDs), cardiac resynchronization pacemakers or defibrillators (CRT-P or CRT-D) have additional specific issues when performing exercise. No study investigated the effects of different inspiratory muscle training protocols. For this reason, we aimed to investigate the effects of inspiratory muscle training on outcomes in hearth failure patients with pacemaker

NCT ID: NCT03052829 Completed - Clinical trials for Cardiovascular Diseases

Physical Activity and Pacemaker Study

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The benefits of regular physical activity are well-established. Furthermore, the investigators have previously shown that in a population of patients with implanted pacemakers, those who exercise more than 2 hours daily have improved survival compared with those who exercise less than 2 hours daily. In this study, the aim f the investigators is to determine whether the offering subjects with pacemakers who have low levels of physical activity at baseline counseling to increase physical activity levels is effective as measured by their implanted device as well as by an external pacemaker. The investigators seek to enroll about 30 patients into a 6-month 1:1 randomized interventional trial comparing the levels of physical activity in 2 groups, those who receive physical activity counseling versus usual care. The activity levels will be measured with external pedometers and with accelerometers embedded within the pacemaker device.