Clinical trials: Bradycardia, active
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
Acute Myocardial Infarction (AMI), Asystole
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…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
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
Atrial Fibrillation (AF), Atrial Flutter
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.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardia (SVT), Ventricular Tachycardia (VT)
- Trial name
- Japan H2H (NCT07870837)
- Testing
- Application of ambulatory cardiac monitor
- Where
- 4 sites in Japan
- Volunteers
- 130 people
- Sponsor
- iRhythm Technologies, Inc.
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
Heart Failure, Bradycardia
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…
- Trial name
- NCT06540521
- Testing
- No intervention
- Where
- 2 sites in China
- Volunteers
- 95 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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, Bradycardia
Merlin Expanded ECG NSR
This clinical investigation is a prospective, single-arm, multi-center, observational study designed to evaluate the concordance between a simplified electrocardiogram (ECG) method implemented on the Merlin™ 3650 or MER3700…
- Trial name
- NCT07877805
- Testing
- Left Bundle Branch Implant
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Infant, Premature, Diseases, Premature Birth of Newborn
Elevated Midline Positioning During Diaper Change in Preterm Infants
Diaper changing is one of the most frequent routine care procedures in the neonatal intensive care unit (NICU) and is known to cause physiological instability and behavioral stress responses in preterm infants.
- Conditions
- Infant, Premature, Diseases, Premature Birth of Newborn, Pain
- Trial name
- NCT07865897
- Testing
- 30-Degree Elevated Midline Positioning, Standard Lateral Position Diaper Change
- Volunteers
- 80 people
- Sponsor
- Akdeniz University
Bradycardia
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.
- Trial name
- Micra CED (NCT03039712)
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
Bradycardia
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.
- Trial name
- NCT04235491
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
Bradycardia, Atrioventricular Block
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…
- Conditions
- Bradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block
- Trial name
- SEPTA PMCF (NCT07209852)
- Testing
- Pacemaker lead
- Where
- 13 sites in Belgium, France and 5 more
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
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
Hypertension, Bradycardia
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…
- Trial name
- CS-10 (NCT05719454)
- Testing
- CNT testing
- Where
- 7 sites in Czechia, Hungary and 1 more
- Volunteers
- 30 people
- Sponsor
- BackBeat Medical Inc
Apnea Neonatal, Bradycardia Neonatal
Application to Predict Neonatal Apnea With Bradycardia
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
- Trial name
- APNeA (NCT06852053)
- Testing
- Closed-loop Vibro-Tactile Stimulator, Control
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
Bradycardia, Right Ventricular Pacing
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.
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- LBBAP PMCF (NCT07217392)
- Testing
- LBBAP lead
- Where
- 15 sites in Brazil, France and 7 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices