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Pacemaker Ddd clinical trials

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NCT ID: NCT06371846 Recruiting - Pacemaker DDD Clinical Trials

Comparative Study of the Surface Electrocardiogram Signals During the Implantation of Conduction System Pacing Devices

Start date: March 14, 2023
Phase:
Study type: Observational [Patient Registry]

Introduction and objectives: Left bundle branch area pacing (LBBAP), is a novel modality of physiologic pacing that requires an adequate assessment of the endocardium as well as the body-surface electrocardiographic signals for a successful pacing-lead implantation. The objective of the study consist of assessing if LBBAP criteria, specifically septal and left bundle branch pacing (LBBP) criteria, can be satisfactory measured using the signals resulting from different cardiac pacing analyzers (PSAs) by comparing them to the 'conventional' signals obtained from multichannel polygraph systems (MPSs) during the implantation procedure. Methods: Comparative observational, prospective, multicenter study between the signals obtained by PSA vs MPS of consecutive patients who underwent a LBBAP strategy as first intention.

NCT ID: NCT06318130 Recruiting - Pacemaker DDD Clinical Trials

Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes

LEAD-LBP
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (EHL) compared to the fixed helix, lumenless pacing lead (FHL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance.

NCT ID: NCT05884359 Recruiting - Clinical trials for Left Bundle-Branch Block

Left Bundle Branch Area Mapping for Conduction System Pacing

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

This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases and using the data to improve understanding of electro-anatomical characteristics of this area for a better definition of the implantation target and depth.

NCT ID: NCT05883514 Recruiting - Pacemaker DDD Clinical Trials

The Feasibility of Motivational Interviewing on Emotional Intelligence, Dispositional Optimism, and Adherence to Care Practices Among Patients With Permanent Pacemaker

Start date: April 15, 2023
Phase: N/A
Study type: Interventional

A cardiac pacemaker is an artificial apparatus that stimulates the myocardium electrically to depolarize, to begin a contraction when the heart's natural pacemaker does not work properly. Pacemakers are essential when dysrhythmias or conduction defects compromise the electrical system and the heart's hemodynamic response. The current status aimed to assess the feasibility of motivational interviewing on emotional intelligence, dispositional optimism, and adherence to care practices among patients with permanent pacemaker.

NCT ID: NCT05868616 Recruiting - Heart Failure Clinical Trials

Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

NIME-CRT
Start date: March 21, 2023
Phase:
Study type: Observational

Left bundle branch block (LBBB) exists in about 25% of patients with congestive heart failure and is associated with worsened prognosis. Cardiac resynchronization therapy (CRT) has been one of the most important advancements in the past two decades for patients with LBBB heart failure. However, 30-40% of patients receiving a CRT do not benefit from it. In this study, the investigators will test a noninvasive device to evaluate acute effect of CRT during implantation and at follow-up CRT controls. In addition, echocardiography will be performed during CRT turned ON and OFF to visualize the changes in intraventricular flow and functional parameters of the heart.

NCT ID: NCT05015660 Recruiting - Pacemaker DDD Clinical Trials

Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing

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

High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF). High percentage ventricular pacing and wider paced QRS in the setting of normal baseline LV ejection fractions have consistently been shown to be independent risk factors for pacing-induced cardiomyopathy. Left bundle branch pacing (LBBP) has emerged as a potential alternative pacing mechanism that may avoid LV dyssynchrony and pacing-induced LV dysfunction by mimicking native electrical conduction.

NCT ID: NCT04416958 Recruiting - ICD Clinical Trials

Pacing to Maintain Physiologic Ventricular Activation

Pace-Conduct
Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

Right ventricular pacing causes ventricular dyssynchrony and may be associated with impaired outcome. In the last decade, several approaches for more physiological pacing became available and were implemented in the latest guidelines. However, compared to conventional device implantation, cardiac resynchronization, His bundle pacing and left bundle area pacing remain demanding procedures in the individual case. Goal of the single center observational "Pace conduct" study is to evaluate implantation success, safety and outcome of pacing methods that maintain physiologic ventricular activation.

NCT ID: NCT03357926 Recruiting - Atrial Fibrillation Clinical Trials

Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients

SAFE-ME
Start date: March 1, 2017
Phase:
Study type: Observational

Atrial fibrillation (AF) is associated with a five-fold increased risk of cerebrovascular stroke. While the risk of stroke in patients with known AF can be calculated via AF stroke prediction risk scores, the prediction of AF occurrence per se in individual patients remains difficult. We will recruit 250 patients with an implanted dual-chamber Pacemaker (PM) or an implantable cardioverter Defibrillator (ICD) with atrial lead to ensure continuous rhythm monitoring during follow up. At baseline, we will gather clinical and device data of patients. For AF prediction based on surface Electrocardiography (ECG), 24-h Holter ECG monitoring will be performed. After 6 months, we will assess the occurrence of AF during the study period via interrogation of PM/ICD. The resulting data will be used to develop algorithms including clinical, device and ECG data for prediction of the development of AF in individual patients. If possible, we will develop a risk score of high accuracy by combination of demographical, clinical and technical parameters of device patients. The resulting risk score could potentially help to facilitate the decision if anticoagulation is necessary in patients with either risk of AF or embolic stroke of unknown origin. Furthermore, Hayn et al. (AIT Austrian Institute of Technology) are currently developing algorithms to predict the occurrence of AF surface ECG data. It is an additional aim of this project to support the development of this algorithm in pacemaker and ICD patients and to increase the accuracy of AF prediction with clinical parameters and other parameters available to patients with implanted pacemaker (PM) or implanted cardioverter-defibrillator (ICD).

NCT ID: NCT02931760 Recruiting - Pacemaker Ddd Clinical Trials

Placement Of Cardiac PacemaKer Trial (POCKET)-RCT

POCKET-RCT
Start date: October 2016
Phase: N/A
Study type: Interventional

Aim: To compare patient satisfaction with intramuscular placement of a pacemaker pocket to subcutaneous placement. Patients will be randomized (approximately half i each group) to receive the pacemaker device either subcutaneously (current practise) or intramuscular)