Clinical trials: Leadless Pacemaker
AV Block, AV Block Complete
Accelerometer Sensing for Micra AV Study
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
- Conditions
- AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
- Trial name
- AccelAV (NCT04245345)
- Testing
- Accelerometer Sensing for Micra AV Study
- Where
- 20 sites in United States, Hong Kong
- Volunteers
- 157 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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
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
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
Bradycardia
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.
- Trial name
- NCT02030418
- Testing
- Leadless Pacemaker
- Where
- 59 sites in United States, Australia and 1 more
- Volunteers
- 952 people
- Sponsor
- Abbott Medical Devices
Cardiac Rhythm Disorder, Bradycardia
The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
- Trial name
- NCT04559945
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- 53 sites in United States, Canada and 6 more
- Volunteers
- 1,276 people
- Sponsor
- Abbott Medical Devices
Cardiac Rhythm Disorder, Bradycardia
Patient Preferences for Leadless Pacemakers
Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers
- Conditions
- Cardiac Rhythm Disorder, Bradycardia, Cardiac Pacemaker Artificial
- Trial name
- NCT05327101
- Testing
- Patient Preference Survey
- Where
- 11 sites in United States
- Volunteers
- 117 people
- Sponsor
- Abbott Medical Devices