Clinical trials: Heart Rate Low
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
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
Bradycardia, A-V Block
PV Loops With CNT in Multiple Pacing Sites
In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV.
- Trial name
- CS-07 (NCT05345925)
- Testing
- Moderato
- Where
- Poland
- Volunteers
- 5 people
- Sponsor
- BackBeat Medical Inc
Bradycardia, Cardiac Resynchronization Therapy
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
- Conditions
- Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Trial name
- POLARIS (NCT06453850)
- Testing
- Use of FLEXIGO delivery catheter
- Where
- 17 sites in France, Germany and 3 more
- Volunteers
- 216 people
- Sponsor
- MicroPort CRM
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
Bradycardia
Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment
The interest of the CAPRI study is to confirm the safety and the efficacy of the ENO/TEO/OTO pacing system when used under 1.5 or 3 Tesla MRI environment and in accordance with the MRI solutions guideline.
- Trial name
- CAPRI (NCT03811691)
- Testing
- MRI exam
- Where
- France
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
Bradycardia, Tachycardia
Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)".
- Trial name
- ASSUREMRI (NCT03012568)
- Testing
- SJM Implantable cardiac devices
- Where
- 3 sites in Australia, India
- Volunteers
- 119 people
- Sponsor
- Abbott Medical Devices
Ventricular Pacing With Rate Response, Bradycardia
Chronic Evaluation of Novel Pacemaker System
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.
- Trial name
- NCT06056817
- Testing
- Calyan Pacemaker
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Calyan Technologies
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
Arrythmia, Bradycardia
Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
Temporary cardiac pacing with active-fixation leads (TPAFL) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation.
- Trial name
- TEMPACE (NCT05351658)
- Testing
- KronoSafe® System
- Where
- 2 sites in Spain
- Volunteers
- 30 people
- Sponsor
- ICU Medical Technologies S.L.
Bradycardia, Tachycardia
St. Jude Medical Product Longevity and Performance (SCORE) Registry
SCORE is an active, prospective, non-randomized, multi-center outcome-oriented registry of patients implanted with St Jude Medical (SJM) market-released cardiac rhythm management (CRM) products.
- Conditions
- Bradycardia, Tachycardia, Heart Disease
- Trial name
- NCT01754064
- Testing
- Cardiac Rhythm Management device
- Where
- 80 sites in United States
- Volunteers
- 10,957 people
- Sponsor
- Abbott Medical Devices
Bradycardia
Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication
The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and…
- Trial name
- TendrilMRI™ (NCT01528150)
- Volunteers
- 466 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Heart Failure
Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
The purpose of this study is to demonstrate the safety and effectiveness of the VDI UHF-ECG System in the diagnosis of ventricular dyssynchrony when compared to the 12-lead ECG in patients with bradycardia and heart failure…
- Conditions
- Bradycardia, Heart Failure, Ventricular Dysfunction
- Trial name
- SYNC (NCT06641362)
- Testing
- Ultra High Frequency Electrocardiogram (UHF-ECG)
- Where
- 12 sites in United States, Czechia and 1 more
- Volunteers
- 360 people
- Sponsor
- VDI Technologies
Atrial Fibrillation (AF), Tachycardia
Evaluation of a Test Algorithm for Use to Analyze ECG Data Collected From a Test Device of a 24-hour Simulated Use Period
The purpose of this study is to demonstrate that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human…
- Conditions
- Atrial Fibrillation (AF), Tachycardia, Bradycardia, PVC - Premature Ventricular Contraction
- Trial name
- NCT07188129
- Testing
- Test Algorithm and Test Device
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- Zywie, Inc.
Bradycardia, Heart Failure
Eluna Family / Sentus BP Master Study
The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna pacemaker family and the Sentus BP (bipolar) left ventricular lead.
- Trial name
- NCT02059629
- Testing
- Eluna pacemaker family, Sentus BP lead
- Where
- 17 sites in Austria, Belgium and 3 more
- Volunteers
- 167 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia
Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect…
- Trial name
- PREMS (NCT02174484)
- Where
- 49 sites in France
- Volunteers
- 571 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia, Heart Block
Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated.
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome
- Trial name
- NCT00180557
- Testing
- Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip
- Where
- Austria
- Volunteers
- 120 people
- Sponsor
- Guidant Corporation
Bradycardia
ULTRA Study for Pacemaker Patients
The ULTRA study will assess the difference in average ventricular voltage output for pacemaker patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF.
- Trial name
- NCT00133289
- Testing
- Pacemaker with Automatic Capture
- Where
- United States
- Volunteers
- 950 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block, Normal Sinus Rhythm With 2 or 3° AV or BBB Block
Evaluation of a New Cardiac Pacemaker
An evaluation of a safety and performance of a new cardiac pacemaker
- Conditions
- Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block, Normal Sinus Rhythm With 2 or 3° AV or BBB Block, Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings
- Trial name
- NCT01700244
- Testing
- Pacemaker implant
- Where
- 8 sites in Czechia, Germany and 1 more
- Volunteers
- 36 people
- Sponsor
- Nanostim, Inc.
Cardiac Pacemaker, Arrythmia
Aveir VR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05270499
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 3,427 people
- Sponsor
- Abbott Medical Devices