Clinical trials: Implantable Cardioverter Defibrillator
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
Implantable Cardioverter Defibrillator (ICD)
Observational BELgian Registry of Implanted EV-ICD to Evaluate Parameters and Complications of the New Device in Real World Settings
The goal of this observational study is to follow all patients implanted with extravascular implantable cardioverter-defibrillators (EV-ICDs) in Belgium throughout the lifetime of the devices.
- Trial name
- BELIEVE (NCT07156851)
- Where
- 7 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- AZ Sint-Jan AV
Heart Disease, Implantable Cardioverter Defibrillator (ICD)
Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD
This is a pragmatic, two-group, cluster randomized trial designed to compare strategies for the Anti Tachycardia Pacing (ATP)-setting in the ventricular tachyarrhythmias (VT) zone when implanting a new implantable cardioverter…
- Conditions
- Heart Disease, Implantable Cardioverter Defibrillator (ICD), Heart Rhythm Disorders, Ventricular Tachyarrhythmias
- Trial name
- DAN-ATP (NCT07354347)
- Testing
- Burst, Ramp
- Where
- Denmark
- Volunteers
- 3,980 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
VT Ablation, Arrhythmic Burden
Treatment Based on High Precision Cardiac Mapping
APOLO-VT aims to evaluate the feasibility, safety, and clinical impact of an integrated multimodal mapping workflow combining non-invasive structural and functional substrate characterization using Volumetric Electrocardiographic…
- Conditions
- VT Ablation, Arrhythmic Burden, Implantable Cardioverter-Defibrillator (ICD) Therapies, Slow-conduction Substrate
- Trial name
- APOLO-VT (NCT07746336)
- Testing
- ACORYS Mapping System
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Hospital Clinic of Barcelona
Heart Failure, Implantable Cardioverter Defibrillator (ICD)
Comparison of the Effects of Different Upper Extremity Aerobic Exercise Training Protocols on Arm Functional Capacity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
1. To determine the most suitable exercise protocol for upper extremity aerobic exercise training, a widely used type of aerobic exercise to improve reduced upper extremity functional capacity in individuals with CIED and HF. 2.
- Conditions
- Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07592494
- Testing
- High-Intensity Interval Upper Extremity Aerobic Exercise Training, Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training, Lower Extremity Aerobic Exercise Training
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people
- Sponsor
- Erol Olcok Corum Training and Research Hospital
Implantable Cardioverter-Defibrillators
Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.
- Trial name
- T-DEF (NCT04206371)
- Testing
- Defibrillator threshold testing
- Where
- 7 sites in France
- Volunteers
- 143 people
- Sponsor
- CMC Ambroise Paré
Pacemaker, Implantable Cardioverter Defibrillator
Comparison of Upper Extremity Function, Physical Activity Levels and Peripheral Muscle Strength, Fear of Movement, Balance, Activities of Daily Living and Quality of Life in Patients With Pacemakers According to Pacemaker Type
While research and clinical practice have demonstrated the objective benefits of pacemaker use on mortality, morbidity, and quality of life, some patients do not experience the expected level of improvement following device…
- Conditions
- Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy
- Trial name
- NCT06775691
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Erol Olcok Corum Training and Research Hospital
Implantable Cardioverter Defibrillator (ICD)
To Test an e-Health Educational Intervention Patients With an ICD
Role of the implantable cardioverter defibrillator (ICD) is to monitor heart rate and discharge a small electrical discharge or shock if the heart rate becomes life threatening.
- Trial name
- CHOICE-ICD (NCT06667505)
- Testing
- Choice-ICD
- Where
- 2 sites in United Kingdom
- Volunteers
- 256 people
- Sponsor
- University of Ulster
Implantable Cardioverter Defibrillator(ICD)
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy
- Trial name
- BIO|ATP (NCT05426785)
- Testing
- 1:1 ratio for Treatment Group and Control Group
- Where
- Japan
- Volunteers
- 398 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Primary Prevention of Sudden Cardiac Death
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in…
- Conditions
- Heart Failure, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- Trial name
- DILEMMA (NCT05373940)
- Testing
- ICD implantation, No ICD implantation
- Where
- 19 sites in France
- Volunteers
- 730 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Implantable Cardioverter-defibrillators (ICDs)
Nursing Intervention Guided by an ICD Nursing Guideline
This study aimed to evaluate evidence-based nursing intervention guided by an ICD nursing guideline on self-efficacy, device acceptance, satisfaction with nursing care, and outcome expectations among ICD candidates during the…
- Trial name
- NCT07449559
- Testing
- nursing care with an evidence-based ICD nursing guideline
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Hacettepe University
Implantable Defibrillator User, Hypertrophic Cardiomyopathy
Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
Pilot randomised trial to assess recruitment for a larger trial to compare the efficacy and adverse effects of the subcutaneous and transvenous ICD in patients with hypertrophic cardiomyopathy (HCM) and indication for ICD…
- Conditions
- Implantable Defibrillator User, Hypertrophic Cardiomyopathy, Implantable Cardioverter Ventricular Lead Dysfunction or Complication, Ventricular Arrythmia
- Trial name
- HICD (NCT05938283)
- Testing
- Implantable Cardioverter Defibrillator implant
- Where
- United Kingdom
- Volunteers
- 5 people
- Sponsor
- Barts & The London NHS Trust
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
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
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