Clinical trials: Defibrillators, Implantable
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
Pacemaker, Defibrillators, Implantable
Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation
Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication.
- Trial name
- NCT06330675
- Testing
- Early mobilization, Standard of care
- Where
- Switzerland
- Volunteers
- 558 people
- Sponsor
- Caporali Elena
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
Heart Failure, Heart Failure With Reduced Ejection Fraction
Assessment of Combined CCM and ICD Device in HFrEF
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy
- Trial name
- INTEGRA-D (NCT05855135)
- Testing
- OPTIMIZER® Integra CCM-D System (Treatment Arm)
- Where
- 59 sites in United States
- Volunteers
- 300 people
- Sponsor
- Impulse Dynamics
Defibrillators, Implantable, Follow-Up Studies
Remote Programming of Cardiac Implantable Electronic Device
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated and reprogrammed to ensure proper functioning.
- Conditions
- Defibrillators, Implantable, Follow-Up Studies, Pacemaker, Artificial, Telemedicine
- Trial name
- REACT (NCT05366660)
- Testing
- Interrogation/programming
- Where
- France
- Volunteers
- 110 people
- Sponsor
- University Hospital, Bordeaux
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 Defibrillator User
TRAjectories and CLinical ExpeRiences of ICD Therapy Study
This is a prospective cohort study of older patients receiving implantable cardioverter-defibrillators. The purpose of the TRACER-ICD study is to conduct a prospective cohort investigation with the goal of 500 patients age >65…
- Trial name
- TRACER-ICD (NCT05116176)
- Testing
- Implantable cardioverter-defibrillators
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Beth Israel Deaconess Medical Center
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 Arrest, Implantable Defibrillator User
Effectiveness of Exercise After an ICD
This study will test an exercise intervention (E-ICD) following an implantable cardioverter defibrillator.
- Conditions
- Heart Arrest, Implantable Defibrillator User, Physical Activity
- Trial name
- E-ICD (NCT03544489)
- Testing
- E-ICD Intervention
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- University of Washington
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
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