Clinical trials: Pacemaker
Cardiac Pacing, Cardiac Pacemaker
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.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
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).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Intracardiac Thrombus, Intracardiac Mass
AngioVac Aspiration Therapy Registry
As a structured, multinational retrospective registry the AVATAR Registry addresses the following scientific aspects through systematic data collection, centralized quality control, and robust statistical analysis in patients…
- Conditions
- Intracardiac Thrombus, Intracardiac Mass, Intravascular Thrombosis, Vegetation; Heart
- Trial name
- AVATaR (NCT07769320)
- Testing
- Retrospective analysis of assigned treatment
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- Charite University, Berlin, Germany
Cardiac Pacemaker, Arrythmia
Aveir VR Coverage With Evidence Development Post-Approval Study
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).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- CED (NCT05336877)
- Testing
- Aveir VR Leadless Pacemaker System, Single-Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 8,744 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrythmia
AVEIR DR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05932602
- Testing
- Aveir DR Leadless Pacemaker System, Dual Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 2,812 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrhythmia
Aveir AR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).
- Conditions
- Cardiac Pacemaker, Arrhythmia, Bradycardia
- Trial name
- ARRIVE (NCT06100770)
- Testing
- Aveir AR Leadless Pacemaker, Single-chamber atrial transvenous pacemaker
- Where
- United States
- Volunteers
- 586 people
- Sponsor
- Abbott Medical Devices
Bradyarrhythmias, AV Block Complete
Belgo-Luxembourg Leadless PM Registry
This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott.
- Conditions
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1, Pacemaker
- Trial name
- BELLA (NCT07879716)
- Testing
- CT scan heart, 24 hour ambulatory ECG monitoring
- Where
- 9 sites in Belgium, Luxembourg
- Volunteers
- 190 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Atrial Fibrillation, Pacemaker Ddd
Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
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…
- Conditions
- Atrial Fibrillation, Pacemaker Ddd, ICD
- Trial name
- SAFE-ME (NCT03357926)
- Testing
- 24 hour Holter ECG Monitoring
- Where
- Austria
- Volunteers
- 250 people
- Sponsor
- Medical University of Graz
Leadless Pacemaker, Bradycardia
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…
- Conditions
- Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
- Trial name
- BIO-LivIQ (NCT07118358)
- Testing
- LivIQ Leadless Pacemaker System
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 325 people
- Sponsor
- Biotronik, Inc.
Cardiac Pacemaker, Cardiac Rhythm Disorder
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.
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT07287423
- Testing
- AVEIR CSP Leadless Pacemaker System
- Where
- Czechia
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Pacemaker DDD
Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
Left bundle branch block (LBBB) exists in about 25% of patients with congestive heart failure and is associated with worsened prognosis.
- Conditions
- Heart Failure, Pacemaker DDD, Cardiomyopathies, Heart Diseases
- Trial name
- NIME-CRT (NCT05868616)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- Norway
- Volunteers
- 80 people
- Sponsor
- Oslo University Hospital
Cardiac Amyloidosis, Pacemaker
Elevated Rate Pacing of Cardiac Amyloidosis
This study aims to better quantify the improvements in heart failure symptoms and exercise tolerance before and after the heart rate elevation in a cohort of 10 cardiac amyloidosis patients with preexisting pacemakers.
- Trial name
- NCT07583823
- Testing
- Pacemaker Rate
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Minnesota
Pacemaker, Defibrillators, Implantable
Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation
Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication.
- Trial name
- NCT06330675
- Testing
- Early mobilization, Standard of care
- Where
- Switzerland
- Volunteers
- 558 people
- Sponsor
- Caporali Elena
Symptomatic Bradycardia, Cognitive Function
PACE Cognition Proof-of-Concept Study
This proof-of-concept study will evaluate whether physiologic pacemaker programming improves cognitive function and health status in patients with symptomatic bradycardia who require permanent pacemaker implantation.
- Conditions
- Symptomatic Bradycardia, Cognitive Function, Pacemaker, Health Status
- Trial name
- NCT07769424
- Testing
- Physiologic Pacemaker Programming, Standard Pacemaker Programming
- Where
- 2 sites in United States
- Volunteers
- 110 people
- Sponsor
- University of Minnesota
Leadless Pacemaker, Transthoracic Echocardiography
Ultrasound Guided Leadless Pacemaker Implantation
The leadless pacemaker is a novel pacing technology that has emerged in recent years. Compared with conventional lead pacemakers, its design avoids many complications associated with leads and pacemaker pockets, including lead…
- Trial name
- NCT07857330
- Testing
- Transthoracic echocardiography-guided, Conventional fluoroscopy-guided, Leadless pacemkaer
- Volunteers
- 288 people
- Sponsor
- China National Center for Cardiovascular Diseases
Pacemaker
Virtual E-health System for Pacemakers
While remote monitoring (RM) technology is currently available and has permitted surveillance and device assessment from any patient location, the use has been inconsistent in Canada, where only 8500 out of a potential 120 000…
- Trial name
- VIRTUES PM (NCT03636230)
- Testing
- Remote Monitoring, Standard of care
- Where
- 11 sites in Canada
- Volunteers
- 848 people
- Sponsor
- Ratika Parkash
Tricuspid Regurgitation, CIED Implantation
3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device
The goal of this observational study is to learn about the development and worsening of tricuspid regurgitation (TR) in patients who have cardiac implantable electronic devices (CIEDs).
- Conditions
- Tricuspid Regurgitation, CIED Implantation, Leadless Pacemaker, Pacemaker
- Trial name
- 3DECHO-TR (NCT07793916)
- Testing
- 3D Transthoracic echocardiographic evaluation
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Samsung Medical Center
Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment…
- Conditions
- Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation, Right Ventricular Dysfunction
- Trial name
- LvL-PACE (NCT07534917)
- Testing
- Temporary left bundle branch area pacing, Temporary leadless right ventricular pacing
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Permanent Pacemaker
A Structured Nurse-Led Empowerment Program to Improve Knowledge, Practical Skills, and Self-Care Behaviours in Patients Living With a Permanent Pacemaker
This study evaluates whether a structured nurse-led education and empowerment program improves knowledge, practical self-care skills, and self-care behaviors in adult patients who have recently received a permanent pacemaker.
- Trial name
- NCT07743346
- Testing
- Structured Nurse-Led Empowerment Program
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Kafrelsheikh University
Cardiac Pacing, Permanent Pacemaker Implantation
Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation
This single-center, prospective, randomized, controlled clinical trial aims to evaluate whether ultrasound-guided PECS II block, when added to standard local infiltration anesthesia, improves perioperative analgesia in patients…
- Conditions
- Cardiac Pacing, Permanent Pacemaker Implantation, Postoperative Pain
- Trial name
- PACE-PECS (NCT07739407)
- Testing
- Ultrasound-Guided PECS II Block, Standard Local Infiltration Anesthesia
- Volunteers
- 72 people
- Sponsor
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