Clinical trials: Leadless Pacemaker
Indications for VVI(R) Pacemaker
The LEADLESS Observational Study
The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.
- Trial name
- NCT02051972
- Testing
- Implanted with a Nanostim leadless pacemaker system
- Where
- 32 sites in Czechia, France and 5 more
- Volunteers
- 491 people
- Sponsor
- Abbott Medical Devices
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
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
Bradycardia, Heart Block
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…
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- NCT07802119
- Testing
- Aveir VR Leadless Pacemaker
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Min Shen
Pacing-Induced Cardiomyopathy
Effect of Leadless Pacing on Heart Function
This prospective, un-blinded, randomized, noninferiority, single centre study with 12 month follow-up included patients who were scheduled for a single-chamber PM implant.
- Trial name
- NCT06100757
- Testing
- Micra Transcatheter Pacing System (TPS°, Conventional pacemaker type Medtronic Advisa ADSR03 or Azure XT VR
- Where
- Belgium
- Volunteers
- 51 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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
Block Complete Heart, Atrial Fibrillation
International Ledless Pacemaker Registry
The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers.
- Trial name
- i-LEAPER (NCT05528029)
- Testing
- Leadless Pacemaker (Micra)
- Where
- 12 sites in Belgium, Italy and 1 more
- Volunteers
- 2,000 people
- Sponsor
- Luigi Sacco University Hospital
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
Micra Transcatheter Pacing Study
The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.
- Trial name
- NCT02004873
- Testing
- Micra Pacemaker Implant
- Where
- 56 sites in United States, Australia and 17 more
- Volunteers
- 744 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Leadless Micra Transcatheter Pacemaker, Quality of Life
Quality of Life in Patients Treated With Leadless Pacemakers
The study aims to carry out a domestic multi-center, prospective, non-randomized, non-blinded post-approval study to assess health-related QoL between Micra TPS and conventional PM implantation.
- Trial name
- NCT05958836
- Testing
- pacemaker
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
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
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.
Bradycardia, Pacemaker DDD
Evaluation of VDD Leadless Pacing System During Exercise
The study is a non-randomized, active prospective observational study permitting to report the behavior of Micra AV pacemaker during an exercise.
- Trial name
- NCT06094114
- Testing
- pacemaker follow-up
- Where
- Belgium
- Volunteers
- 42 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Bradycardia, Atrial Tachyarrhythmia
Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
The purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (MICRA device).
- Trial name
- MICRA (NCT02758210)
- Testing
- Use of a Tablet, Use of a Smart Phone
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Emory University
Pacemaker, Atrioventricular Block
Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status
This is a multicenter, prospective, observational study ,the aim of this study is to find factors affecting selection of double-chamber leadless pacemaker in patients with atrioventricular block and ambulatory atrioventricular…
- Conditions
- Pacemaker, Atrioventricular Block, Clinical Trials, Pacing
- Trial name
- NCT06587672
- Testing
- Micra AV implantation
- Where
- 2 sites in China
- Volunteers
- 112 people
- Sponsor
- Xiaohan Fan
Bradycardia
Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker
Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site
- Trial name
- MICRA-SYNK (NCT05817695)
- Testing
- Leadless pacemaker
- Where
- China
- Volunteers
- 40 people
- Sponsor
- First People's Hospital of Hangzhou
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
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
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
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
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.