Clinical Research Directory

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according to applicable guidelines. An integrated atrioventricular synchrony sub-study (AVS) is specifically designed to evaluate the AVS performance of the LivIQ system.

Bolt CSP-M Holter Study

The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.

LEAP 2 Chronic EFS

Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.

BIO|STREAM.CSP Study

The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.

Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan

The goal of this clinical trial is to compare the yield of clinically actionable arrhythmias through the end of indicated wear duration in Zio monitor and Heartnote patch ECG devices.

Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)

The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices. The study uses administrative claims data of the Medicare population implanted with Micra AV leadless pacemakers or dual-chamber transvenous pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.

Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers

The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices. The study uses administrative claims data of the Medicare population implanted with single-chamber ventricular pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.

Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up

The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in patients with bradycardia who need a pacemaker.

Novel Setup Algorithm for Cardiac Neuromodulation Therapy

After meeting all inclusion/exclusion criteria, subjects on standard pacing with the Moderato® or Moderato Plus Implantable Pulse Generator (IPG) will be subjected to two set-up sessions for the CNT algorithm: at week 4 and at week 6 post implant. At the end of these visits, subjects will undergo a 24 ambulatory blood pressure recording after which CNT will be automatically turned OFF and standard pacing will resume. The ambulatory data will provide the basis for a lasting CNT programming by week 8. Follow up visits will be scheduled after 3, 6, and 12 months.

BIO|MASTER.CSP Study

The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP). The patient population consist of patients with cardiac pacemaker indication or cardiac resynchronization therapy indication and intended for implantation of a system with left bundle branch area stimulation. Participants will visit sites at enrollment in the study, at implantation and pre-hospital discharge, 1-, 6- and 12-month follow-up visits. Additional annual follow-up(s) may apply until study termination after regulatory approval of Solia CSP S. The total duration of the clinical investigation is expected to be until September 2027, with last patient out (LPO). During the visits the regular pacemaker and lead measurement are performed. A 12-lead ECG is recorded to document intrinsic and ventricularly paced heart rhythm to assess left bundle branch area pacing. Programming of the pacemakers will be done according to the participant´s therapeutical needs. The study will be conducted in approximately 18 sites in Europe, Australia and New Zealand where more than one physician per site are expected to participate.

Left Bundle Branch Area Pacing (LBBAP) PMCF Study

The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.

Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum

The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.

Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum

The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.

Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction

The study is a prospective, randomized controlled study in hypertensive patients with a bradycardia indications for pacing therapy and a plan to receive dual-chamber pacemaker. Enrolled patients will be randomized 1:1 into the control group and the allometric-pace group. In the control group, the pacing lower rate will be set to the nominal 60 bpm post a dual-chamber pacemaker implantation as frequently used in clinical practice, while in the allometric-pace group, the pacing rate will be programmed at 75 bpm based on the estimation for Chinese population with a height of 165-170 cm (also called personalized lower rate) or based on the symptom-relief per clinical assessment by the study physicians. Each patient will undergo baseline assessments and 3-month follow-up visits. At the enrollment and office visits, each patient will undergo arterial blood pressure measurement, cardiac functional assessment and cerebral blood flow measurement. At the end of the study, the study physician will adjust pacing lower rate based on patients' conditions and clinical assessments. After the completion of the study, all patients will have regular device follow-up visit, usually 6-month interval or annually. Each patient will receive the following major assessments: device performance and pacing percentages, ventricular diastolic function by doppler and echocardiography of LVEF, LVEDV, LVESV, stroke volume, cardiac output, arterial blood pressure measurements, cerebral blood flow by MRI or Echo (which one will be determined later by the study PIs), and Mini-Mental State Examination (MMSE).

SPIKE FLOW Endocardial Lead Safety and Performance Study

The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: * safety in terms of freedom from Serious Adverse Events(SADEs); * performance in terms of Mean Pacing Capture Threshold. Secondary objectives are to assess: * safety in terms of freedom from Adverse Events (ADEs); * performance in terms of Mean Pacing Impedance; * performance in terms of Sensed R-wave Amplitude. The study is a prospective, non-randomized, single-arm, multi-center investigation in 131 adult subjects with 3 investigational sites in Italy. The study is expected to take approximately 1 year to enroll. Enrolled subjects will have visit timepoints at: baseline, lead insertion, lead removal, discharge and 30 days post lead removal.

The Impact of Video-based Cardiac Rehabilitation Education in Patients With CIEDs

Cardiac rehabilitation has the beneficial effects of secondary prevention and social psychological and physical health status in patients with cardiovascular diseases. International and clinical guidelines currently recommend exercise training and rehabilitation for heart failure patients, which can effectively improve mortality and prognosis. However, few of these recommendations have specific recommendations for patients with cardiac implantable electronic devices. Currently the recommendations of cardiac rehabilitation include patients with coronary heart disease (acute coronary heart disease, any coronary revascularization, stable coronary disease or unstable angina), patients with heart failure, after cardiac surgery, and patients with high cardiovascular risk. Many of these patients may be implanted with cardiac implantable electronic devices. In 2011, 938 pacemakers, 140 cardiac resynchronization therapy and 149 implantable cardioverter defibrillators were implanted per million inhabitants in Europe. Therefore, among the groups with cardiac implantable electronic devices, cardiac rehabilitation plays a certain role. The purpose of this study is to evaluate whether video-based cardiac rehabilitation health education for patients with cardiac implantable electronic devices has significantly improved physical activity. This study is designed as a prospective, single center, double-blind, randomized controlled trial. Divided into an experimental group and a control group at a ratio of 1:1. The experimental group with cardiac implantable electronic devices will receive cardiac rehabilitation health education video intervention, and the control group will receive only health education. We aim to recruit 45 participants per group with a total of 90 participants.

Evaluation of the Factors Associated With BRADYcardia Following Pulmonary Vein Isolation Using Pulsed Field Ablation

The study aims to identify factors associated with bradycardia during the hospital stay after ablation of atrial fibrillation performed with pulsed field technology.

Procedural Endpoint in Left Bundle Branch Area Pacing: Conduction System Capture Versus LV Septal Capture

This is a prospective, multicenter, randomized controlled trial designed to determine whether direct capture of the left ventricular conduction system must be achieved as the procedural endpoint of left bundle branch area pacing (LBBAP), or whether left ventricular septal capture alone is sufficient to obtain comparable clinical outcomes. A total of 300 patients aged 19 years or older who have a guideline-based indication for permanent pacemaker implantation for bradyarrhythmia, an expected ventricular pacing burden of 40% or more, and a planned LBBAP procedure will be enrolled at 5 or more centers in the Republic of Korea. Participants will be randomly assigned in a 1:1 ratio, stratified by baseline left ventricular ejection fraction (LVEF \<50% versus \>=50%), to one of two procedural strategies: 1. LBBP mandatory group - the implanting operator continues the procedure, repositioning the lead as required, until left bundle branch pacing (LBBP) or left fascicular pacing (LFP) is confirmed by at least one predefined conduction system capture criterion. 2. LVSP enough group - the operator may complete the procedure at his or her discretion once left ventricular septal pacing (LVSP) is confirmed, irrespective of whether direct conduction system capture is achieved. The same commercially approved lead and pulse generator platform is used in both groups, so the randomized variable is the procedural endpoint strategy rather than the device. The primary outcome measure is the absolute change in LVEF from baseline to 12 months, adjudicated by a blinded central echocardiography core laboratory. Secondary outcome measures include echocardiographic response, pacing-induced cardiomyopathy, procedure-related major complications, procedure and fluoroscopy time, paced QRS duration, acute procedural success, achievement and long-term maintenance of conduction system capture, all-cause death, cardiovascular death, heart failure hospitalization, upgrade to cardiac resynchronization therapy, and new-onset atrial fibrillation. All participants are followed for 12 months after implantation, with study visits at 2 weeks to 1 month, 6 months, and 12 months. The primary analysis follows the intention-to-treat principle, with a prespecified per-protocol analysis according to whether conduction system capture was actually achieved.

Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers

This study is a prospective, single-arm, single-center feasibility study evaluating the safety and feasibility of transjugular (internal jugular vein) implantation of the Aveir VR leadless ventricular pacemaker in patients requiring ventricular pacing. A total of 15 patients will be enrolled at Xijing Hospital. The primary objective is to assess procedural feasibility and acute safety (from intraoperative to 48 hours post-procedure). Secondary objectives include short-term (1 to 3 months) pacing parameter stability (threshold, R-wave amplitude, impedance), technical success rate, procedure-related metrics, and adverse event rates.

Chronic Evaluation of Novel Pacemaker System

The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer

The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a commercially available, standard of care electro-physiology (EP) monitoring and recording device during the pacemaker implantation. Participants receiving a routine de-novo implantation of a pacemaker for left bundle branch area pacing (LBBAP) will undergo the CSP Display System protocol during the implant procedure.

"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients. Patients will be allocated at random to receive either right ventricular pacing or physiological pacing. Endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient. Recruitment and pacemaker implantation will be carried out at each participating centre. The primary analysis will be intention to treat. The investigators will also perform an on-treatment analysis. 2048 patients are needed to detect the expected effect size with 85% power. A total of 2600 patients will be recruited to allow for patient drop-out and crossover. 500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of PICM (Pacing Induced Cardiomyopathy).

HeartBeam ECG Registry

The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.