Clinical trials: Defibrillators
Pacemaker, Implantable Defibrillator
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase)
he Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of…
- Trial name
- RAPTOR - MAIN (NCT07352657)
- Testing
- Alert-based care, Guideline-based Care
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Beth Israel Deaconess Medical Center
Heart Failure, Atrial Fibrillation
Conduction System Pacing and AV Junction Ablation in Heart Failure With Atrial Fibrillation (SYNC AF-HTx)
The purpose of this study is to evaluate the safety and efficacy of conduction system pacing (CSP) using left bundle branch pacing (LBBP) and atrioventricular junction (AVJ) ablation in patients with end-stage heart failure and…
- Conditions
- Heart Failure, Atrial Fibrillation, Defibrillators, Implantable
- Trial name
- NCT07332871
- Testing
- LBBP + AVJ Ablation with ICD, ICD Only
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- Yonsei University
Pacemaker DDD, Implantable Defibrillator User
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
The Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of…
- Trial name
- RAPTOR-CIED (NCT06937658)
- Testing
- Alert-based care, Guideline-based care
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Beth Israel Deaconess Medical Center
Cardiac Arrest (CA), Cardiac Arrest With Successful Resuscitation
A Study on the Impact of a New Canton-Wide First Responder System in Zug, Switzerland, on Survival After Adult Cardiac Arrest-Examining Early Life-Saving Organized Help, Fast Defibrillation, and Improved Outcomes for Out of Hospital Cardiac Arrest
REVIVE Zug: Improving Emergency Response for Out-of-Hospital Cardiac Arrest Out-of-hospital cardiac arrest (OHCA) represents one of the most time-critical medical emergencies, where rapid recognition and immediate intervention…
- Conditions
- Cardiac Arrest (CA), Cardiac Arrest With Successful Resuscitation, Resuscitation, Emergency Medical Services
- Trial name
- REVIVE Zug (NCT07323667)
- Where
- Switzerland
- Volunteers
- 250 people
- Sponsor
- Felix Brinkmann
Implantable Cardioverter Defibrillator (ICD)
In-depth Interviews of Patients With ICDs
Although ICDs are effective in preventing sudden cardiac death, they can also profoundly affect patients' and partner/caregivers' emotional well-being, social relationships, and daily functioning.
- Trial name
- QoLICD-INSIGHT (NCT07258602)
- Testing
- semi-structured interview
- Where
- Belgium
- Volunteers
- 250 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Implantable Cardioverter Defibrillator (ICD)
Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Cross-Sectional Observational Study
Patients at risk for life-threatening arrhythmias are eligible for the implantation of an implantable cardioverter-defibrillator (ICD), which has repeatedly shown improved survival.
- Trial name
- QoL-ICD I (NCT06654232)
- Testing
- quality of life questionnaires
- Where
- Belgium
- Volunteers
- 731 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Implantable Cardioverter Defibrillator (ICD)
Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Longitudinal Observational Study
Patients at risk for life-threatening arrhythmias are eligible for the implantation of an implantable cardioverter-defibrillator (ICD), which has repeatedly shown improved survival.
- Trial name
- QoL-ICD II (NCT06654284)
- Testing
- quality of life questionnaires
- Where
- Belgium
- Volunteers
- 400 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Heart Failure, Implantable Cardioverter Defibrillator (ICD)
Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices
The aim of this study is to evaluate in detail the factors that determine upper extremity function, determine its effect on prognosis, hospital admission, hospitalization, and mortality, and examine the results according to the…
- Conditions
- Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronisation Therapy (CRT), Reduced Ejection Fraction Heart Failure
- Trial name
- NCT07253909
- Testing
- Not applicable- observational study
- Where
- Turkey (Türkiye)
- Volunteers
- 72 people
- Sponsor
- Hacettepe University
Ventricular Tachycardias, Myocardial Infarction (MI)
Endo-ePIcardial Versus Endocardial Only Catheter Ablation for ISchemic Driven Ventricular Tachycardia (EPISODE VT)
The EPISODE VT trial is designed to compare efficacy and safety of two modalities for interventional treatment - endocardial ablation and endo-epicardial ablation in a population of patients with post myocardial infarction (ICD…
- Conditions
- Ventricular Tachycardias, Myocardial Infarction (MI), Implantable Cardiac Defibrillator, Ablation
- Trial name
- EPISODE_VT (NCT07240441)
- Testing
- Endocardial VT ablation, Endo-epicardial VT ablation
- Where
- 9 sites in Poland
- Volunteers
- 220 people
- Sponsor
- MEDICOVER SP Z O.O.
Implantable Defibrillator User, Stress Reaction
Self-Management Interventions After an ICD Shock
This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising…
- Conditions
- Implantable Defibrillator User, Stress Reaction, Ptsd, Stress Management
- Trial name
- NCT06037785
- Testing
- Self-Paced Self-Management (SPSM)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Washington
Pacemakers, MRI Imaging
The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups
SUMMARY OF THE CLINICAL PROTOCOL Background: The risks of Magnetic Resonance Imaging (MRI) at 1.5-tesla for patients with a non-MRI-conditional (NMRC) pacemaker have been documented, guidelines for clinical practice have been…
- Conditions
- Pacemakers, MRI Imaging, Implantable Cardioverter Defibrillator (ICD)
- Trial name
- NCT07189728
- Testing
- MRI
- Volunteers
- 1,500 people
- Sponsor
- The Scripps Research Institute
Heart Failure With Reduced Ejection Fraction (HFrEF), Sudden Cardiac Death
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
This prospective, multicenter, open-label, randomized comparative effectiveness trial, titled CARVTOP-ICD, evaluates the impact of carvedilol versus metoprolol succinate in patients with heart failure with reduced ejection…
- Conditions
- Heart Failure With Reduced Ejection Fraction (HFrEF), Sudden Cardiac Death, Ventricular Arrhythmia, Implantable Cardioverter Defibrillator (ICD)
- Trial name
- CARVTOP-ICD (NCT06964464)
- Testing
- Metoprolol Succinate, Carvedilol
- Where
- 13 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- University of Rochester
Pacemaker, Implantable Cardioverter-defibrillator
Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices.
Venous access is a fundamental step in lead insertion for endovenous cardiac implantable electronic devices (CIED). Cephalic vein cutdown is the most widely used technique in Europe.
- Trial name
- NCT04649788
- Testing
- Ultrasound-guided axillary vein access, Cephalic vein access
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Hospices Civils de Lyon
Telemedicine, Heart Failure
Electronic Device Implantation Through Remote Guidance
Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants are limited by availability and costs of field clinical specialist (FCS) bioengineers.
- Conditions
- Telemedicine, Heart Failure, Defibrillators
- Trial name
- NCT06404021
- Testing
- interventional cardiology procedures with proctoring system, interventional cardiology procedures with engineer in the electrophysiology laboratory
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Calabria
Ventricular Tachycardia, Ventricular Fibrillation
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
- Trial name
- DATAS (NCT00157820)
- Testing
- Single Chamber Implantable Cardioverter Defibrillator, Dual Chamber implantable cardioverter defibrilator
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Pacemaker, Defibrillator
Remote Programming of Cardiac Implantable Electronic Devices 2
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning.
- Conditions
- Pacemaker, Defibrillator, Telemedecine
- Trial name
- REACT 2 (NCT06272344)
- Testing
- Teleconsultation
- Where
- France
- Volunteers
- 36 people
- Sponsor
- University Hospital, Bordeaux
Ventricular Tachycardia, Monomorphic, Ventricular Tachycardia, Sustained
Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia
The aim of the study is to compare the efficacy and safety of treating recurrent sustained Ventricular Tachycardia (sVT) after prior Catheter Ablation (CA) in patients with Implanted Cardioverter-Defibrillator (ICD) between re-do…
- Conditions
- Ventricular Tachycardia, Monomorphic, Ventricular Tachycardia, Sustained, Ventricular Tachycardia (VT), Ventricular Tachycardia (V-Tach)
- Trial name
- STAR-4VT (NCT07017855)
- Testing
- Stereotactic Arrhythmia Radioablation (STAR), Catheter Ablation
- Where
- Poland
- Volunteers
- 150 people
- Sponsor
- Medical University of Silesia
Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
The recent study is planned to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart…
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy
- Trial name
- ERASE (NCT04600921)
- Testing
- Ertugliflozin 5 mg
- Where
- 8 sites in Austria
- Volunteers
- 55 people
- Sponsor
- Medical University of Graz
Ventricular Arrhythmias and Cardiac Arrest, Implantable Defibrillator User
Targeted Potassium Levels for Prevention of ICD Therapy
This study evaluates whether a rigorously controlled high-normal level of serum-potassium (4.5-5.0 mEq/L) using dietary recommendations, potassium supplements and mineralocorticoid receptor antagonists will results in a lower…
- Conditions
- Ventricular Arrhythmias and Cardiac Arrest, Implantable Defibrillator User, Hypokalemia, Hyperkalemia
- Trial name
- NCT03833089
- Testing
- Targeted serum potassium level
- Where
- 3 sites in Denmark
- Volunteers
- 1,200 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Patient Acceptance of Health Care, Nursing
Mobile Education and Telephone Monitoring for ICD Patients: Effects on Anxiety, Acceptance, and Self-Efficacy
Aim: This study was conducted to determine the effect of a mobile education program and telephone monitoring developed for patients with implantable cardioverter defibrillators (ICD) on shock anxiety, device acceptance, and…
- Conditions
- Patient Acceptance of Health Care, Nursing, Implantable Cardioverter Defibrillator (ICD), Self-Efficacy
- Trial name
- NCT06935526
- Testing
- The mobile training program and telephone follow-ups, Only a two-page summary section of M-ICDEP
- Where
- Turkey (Türkiye)
- Volunteers
- 88 people
- Sponsor
- Akdeniz University