Clinical trials: Leadless Pacemaker, open to volunteers
Pacemaker
A Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP (France LEADLESS)
Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not…
- Trial name
- FranceLEADLESS (NCT06262295)
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- French Cardiology Society
Leadless Pacemaker
Aveir Leadless Pacemaker Japan PMS
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing.
- Trial name
- NCT07106788
- Testing
- Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients, Upgrades
- Where
- 14 sites in Japan
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices
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
Leadless Pacemaker, Left Atrial Appendage Occlusion
Combined Leadless Pacemaker and Left Atrial Appendage Occlusion Registry
Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in selected patients. Implantation is performed with a large caliber delivery catheter.
- Trial name
- NCT06702865
- Where
- Hong Kong
- Volunteers
- 47 people
- Sponsor
- Chinese University of Hong Kong
Sick Sinus Syndrome, Atrioventricular Block
Taiwan Registry for Leadless Pacemaker
Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.
- Trial name
- NCT04926792
- Testing
- Leadless Pacemaker
- Where
- Taiwan
- Volunteers
- 300 people
- Sponsor
- National Taiwan University Hospital
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 pacemaker
- Volunteers
- 288 people
- Sponsor
- China National Center for Cardiovascular Diseases
Bradycardia, Brady-tachy Syndrome
ALPs Single ChambEr New Device
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Bradycardia, Brady-tachy Syndrome, AV Block, Atrial Fibrillation (AF)
- Trial name
- ASCEND (NCT07461935)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 10 people
- Sponsor
- Cairdac SA
Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines
AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of…
- Trial name
- NCT06782152
- Volunteers
- 1,698 people
- Sponsor
- King Fahad Armed Forces Hospital
Brady-tachy Syndrome, Brady Arrythmia
ALPs Single ChambEr New Device Study
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Brady-tachy Syndrome, Brady Arrythmia, Bradycardia, AV Block
- Trial name
- ASCEND (NCT07469579)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 15 people
- Sponsor
- Cairdac SA
Vascular Closure, Pacemaker Implantation
Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.
The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker…
- Conditions
- Vascular Closure, Pacemaker Implantation, Leadless Pacemaker
- Trial name
- PERCLOSE-LP (NCT06837870)
- Testing
- percutaneous suture mediated closure, Figure of Eight Suture
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Massachusetts, Worcester
Pacemaker, Leadless Pacemaker
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
The registry for leadless pacemakers will collect and annually analyze the data of all leadless pacemaker implantations at the University Hospital St.
- Conditions
- Pacemaker, Leadless Pacemaker, Cardiac Pacing, Artificial, Registries
- Trial name
- LPR (NCT07246135)
- Where
- Austria
- Volunteers
- 700 people
- Sponsor
- Karl Landsteiner University of Health Sciences
Cardiac Pacemaker, Arrythmia
Aveir DR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05935007
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 1,805 people
- Sponsor
- Abbott Medical Devices
Sinus Pause, Sinus Sick Syndrome
Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning
One of the most serious complications with leadless pacemaker (LP) implants is right ventricle (RV) perforation. Understanding the accuracy of fluoroscopic guidance of implants compared to transthoracic echocardiograms (TTE) and…
- Conditions
- Sinus Pause, Sinus Sick Syndrome, Heart Block, Arrhythmias, Cardiac
- Trial name
- MAP (NCT07908927)
- Testing
- Cardiac Imaging by TTE or CTA
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Bradycardia, Atrio-Ventricular Block
AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry
This observational study will follow patients requiring implantation of leadless pacemaker for 5 years after implantation. The main goal is to evaluate the long term safety and efficacy of AVEIR™ leadless pacemaker device in the…
- Conditions
- Bradycardia, Atrio-Ventricular Block, Syncope
- Trial name
- NCT06854484
- Testing
- AVEIR™leadless pacemaker
- Where
- 2 sites in United Kingdom
- Volunteers
- 300 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Heart Failure
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
- Trial name
- TLC-AU (NCT06561932)
- Testing
- WiSE CRT System
- Where
- 4 sites in Australia
- Volunteers
- 40 people
- Sponsor
- EBR Systems, Inc.
AV Block Complete, AV Block-2Nd Degree-Type 1
Efficacy and Safety of Micra AV2 Transcatheter Pacing System
A third generation, Micra AV2 is now available and proposes increased automaticity and improved AV synchrony algorithms based on computing model.
- Conditions
- AV Block Complete, AV Block-2Nd Degree-Type 1, AV Block
- Trial name
- EMAV2 (NCT07356505)
- Testing
- Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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.
Leadless Pacemaker, Same-day Discharge
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g.
- Trial name
- VAMPIRE (NCT06455566)
- Testing
- Leadless pacemaker implantation through right internal jugular vein
- Where
- 13 sites in France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Caen
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
Atrial Fibrillation, Atrial Septal Defect
Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach (Eight-Clover)
The purpose of this study is to evaluate the clinical efficacy and safety of the Perclose ProStyle™ Suture-Mediated Closure Device in patients undergoing cardiologic procedures via a femoral vein approach using a sheath size of 8…
- Conditions
- Atrial Fibrillation, Atrial Septal Defect, Vascular Closure Device
- Trial name
- Eight-CLOVER (NCT07827287)
- Testing
- Perclose ProStyle™ Suture-Mediated Closure System, Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Ewha Womans University Mokdong Hospital