Clinical trials: Pacemakers
Anxiety, Pain
Impact of Virtual Reality on Anxiety and Pain During Implantation of Cardiac Implantable Electronic Devices (CIED)
Purpose: This study aimed to evaluate whether virtual reality technology positively affects patients' pain and anxiety throughout the entire procedure of implantation of cardiac pacemakers, defibrillators, or cardiac…
- Trial name
- CIED (NCT07250282)
- Testing
- Virtual reality headset
- Where
- Germany
- Volunteers
- 111 people
- Sponsor
- Muhammed Kurt
Heart Block, Heart Failure
Right Apical Versus Septal Pacing Trial
The purpose of this study is to examine whether RV (right ventricular)septal pacing has any effect on LV ( left ventricular) function than RV apical pacing in patients who require ventricular pacing.
- Trial name
- RASP (NCT00199498)
- Testing
- Apical RV lead placement, Septal RV lead placement
- Where
- Canada
- Volunteers
- 160 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Quality of Life (QOL) and Impact of Stress
Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation
The project "Investigating Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation" aims to investigate the relationship between stress and the postoperative healing process…
- Trial name
- NCT07343466
- Testing
- Survey using a questionnaire.
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- University Hospital, Essen
Indication for Cardiac Resynchronization Therapy (CRT)
Evia/Entovis HF-T Master Study
The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers.
- Trial name
- NCT01545739
- Testing
- Evia/Entovis HF-T pacemaker for CRT therapy
- Where
- Hungary
- Volunteers
- 122 people
- Sponsor
- Biotronik SE & Co. KG
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
Amyloid Cardiomyopathy, Block, AV
Screening of ATTRwt in Patient With Advanced AV-Block Undergoing Pacemaker Implantation
The investigators will nationally investigate the prevalence of Transthyretin Amyloidosis wildtype (ATTRwt) in patients of ≥ 65 years with left ventricular hypertrophy who present with high degree atrioventricular block…
- Trial name
- ATTRAB (NCT05699044)
- Testing
- Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)
- Where
- Denmark
- Volunteers
- 170 people
- Sponsor
- Steen Hvitfeldt Poulsen
Atrial Fibrillation
The Role of hs Troponin I and NT-proBNP in Predicting Atrial Fibrillation in Patients With Permanent Pacemakers
The goal of this clinical trial is to answer the research question whether hs Troponin I and NT-proBNP have a role in detecting atrial fibrillation in patients with pacemakers. Objectives of the study: 1.
- Trial name
- NCT06174506
- Where
- Vietnam
- Volunteers
- 300 people
- Sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
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
Heart Disease, Cardiovascular Disease
Remote Interrogation in Rural Emergency Departments
A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REM RED (NCT02421549)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure
Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure
The purpose of this study is to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optimal pharmacologic therapy and 1)…
- Trial name
- NCT00180258
- Testing
- Cardiac Resynchronization Therapy with & without defibrillator
- Where
- United States
- Volunteers
- 2,200 people
- Sponsor
- Boston Scientific Corporation
Magnetic Resonance Imaging, Cardiac Pacemaker, Artificial
Advisa MRI Clinical Study
The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR)…
- Trial name
- NCT01110915
- Testing
- Medtronic Advisa MRI Implantable Pulse Generator (IPG), Medtronic CapSureFix MRI™ active fixation MRI lead
- Where
- 37 sites in United States, Australia and 11 more
- Volunteers
- 269 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Magnetic Resonance Imaging (MRI)
Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging
Researchers are trying to determine if heart injury occurs in subjects with cardiac implantable electronic device (CIED), such as a pacemaker or implantable cardioverter defibrillator (ICD), who undergo a magnetic resonance…
- Trial name
- NCT04151953
- Testing
- Blood sample collection
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- Mayo Clinic
Cardiac Pacing, Right Ventricular Pacing
Optimize RV Follow-up Selective Site Pacing Clinical Trial
The purpose of the Optimize RV Follow-Up study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed.
- Conditions
- Cardiac Pacing, Right Ventricular Pacing, Left Ventricular Ejection Fraction
- Trial name
- ORVFUP (NCT00949715)
- Testing
- Medtronic or Vitatron Dual-Chamber Pacemaker, Medtronic SelectSecure 3830 Lead
- Where
- 12 sites in United States, Israel and 1 more
- Volunteers
- 67 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Cardiac Resynchronisation Pacemakers
Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
An evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers.
- Trial name
- CHOICE2 (NCT01055210)
- Testing
- Optimisation of VV delay
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- University of Dundee
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
Bradycardia; Sick Sinus Syndrome, AV Block
Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.
- Trial name
- NCT00156741
- Testing
- Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2, Required pacemaker setting
- Where
- 30 sites in Austria, Czechia and 9 more
- Volunteers
- 150 people
- Sponsor
- Medtronic BRC
Pacemaker Electrode Lead Fracture, ICD
Adverse Events of MRI With Abandoned Leads
The purpose of this study is to determine the safety and efficacy of MRI scanning in patients with fractured or abandoned endocardial leads.
- Trial name
- NCT04478773
- Testing
- MRI
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Lancaster General Hospital
Atrial Fibrillation, Permanent Atrial Fibrillation
Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial
The goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation…
- Conditions
- Atrial Fibrillation, Permanent Atrial Fibrillation, Persistent Atrial Fibrillation, Pacemaker DDD
- Trial name
- PACE-AF (NCT06377046)
- Testing
- Accelerated pacing, Current standard of care
- Volunteers
- 50 people
- Sponsor
- Maastricht University Medical Center
Aortic Valve Stenosis
Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation
The goal of this prospective, multicenter, investigator-initiated, randomized clinical trial is to assess the safety and efficacy of a 'minimally invasive, upper extremity' approach versus the standard 'lower extremity' approach…
- Trial name
- TAVIXS (NCT05672823)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 8 sites in Netherlands
- Volunteers
- 238 people
- Sponsor
- Radboud University Medical Center
Atrioventricular Block, Sick Sinus Syndrome
AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals
This is a randomized, prospective clinical trial to determine the effects of two different pacemaker atrioventricular delay (AV delay) settings on heart function in patients with dual chamber pacemakers implanted for symptomatic…
- Conditions
- Atrioventricular Block, Sick Sinus Syndrome, Symptomatic Bradycardia, Cardiac Arrhythmia
- Trial name
- AV Delay (NCT02154750)
- Testing
- Long, fixed AV delay, Short, optimized AV delay
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of California, San Diego