Clinical trials: ICD Malfunction, active
Heart Failure and Reduced Ejection Fraction
Developing a Digital Aid to Improve ICD Decisions
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death.
- Trial name
- NCT07084142
- Testing
- Online, patient-facing decision-making aid (app) with personalized risk information., Implantable Cardioverter Defibrillator (ICD), Online, patient-facing decision-making app without personalized risk information.
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- Stanford University
Sudden Cardiac Death
Dilated Cardiomyopathy - Unknown Therapeutic Risk Reduction by Contempary Medication and Implantable Cardioverter-Defibrillators (DUTCH-ICD)
Research questions: The value of primary prevention implantable cardioverter-defibrillator implantation (ICD) therapy in patients with non-ischemic cardiomyopathy (NICM) is under debate.
- Trial name
- DUTCH-ICD (NCT07415642)
- Testing
- ICD implantation
- Where
- 2 sites in Netherlands
- Volunteers
- 720 people
- Sponsor
- University Medical Center Groningen
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
Heart Failure, Heart Failure NYHA Class II
Heart Failure Management for Patient With CIED Remotely Monitored
This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart…
- Conditions
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction (HFrEF)
- Trial name
- PROACT-HF (NCT07247032)
- Testing
- SmartSignalHF, HF RM standard of care
- Where
- France
- Volunteers
- 1,132 people
- Sponsor
- Implicity
Heart Failure, Ischemic Cardiomyopathy
18F-mFBG Imaging for Myocardial Sympathetic Innervation
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation.
- Conditions
- Heart Failure, Ischemic Cardiomyopathy, ICD Patients
- Trial name
- NCT06965621
- Testing
- 18F-metaFluorobenzylguanidine, Rubidium-82
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Heart Failure
Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator
This prospective, multicenter, open-label, randomized-controlled trial compares two treatment strategies in high-risk ischemic cardiomyopathy (ICM) patients referred for primary ICD implantation.
- Trial name
- PREVENT-VT (NCT06543173)
- Testing
- Prophylactic Catheter-based VT Ablation
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 62 people
- Sponsor
- University of Rochester
HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death
Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy
Pilot interventional randomized clinical trial to study the efficacy of left bundle branch pacing in patients with hypertrophic cardiomyopathy after myectomy for the prevention of progression of heart failure, prevent the…
- Conditions
- HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death, Left Bundle Branch Pacing, ICD
- Trial name
- LEFTpaceHCM (NCT07372196)
- Testing
- ICD with left bundle branch area pacing (LBBAP), dual-chamber ICD
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Shared Decision-making
Evaluating a Digital Aid to Improve ICD Decisions
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death.
- Trial name
- NCT07913204
- Testing
- Arm A: Online, patient-facing decision-making aid (app) with personalized risk information., Arm B - Online, patient-facing decision-making app without personalized risk information., Arm C - Usual Care/No Device
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- Stanford University
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
Cardiac Pacemaker Malfunction, ICD Malfunction
Perioperative Management Evaluation in Patients With CIED
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
- Conditions
- Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication
- Trial name
- EVINCE (NCT04331249)
- Testing
- surgery or catheter based cardiac procedure (catheter ablation)
- Where
- 2 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Klinikum-Fuerth
Heart Failure and Reduced Ejection Fraction
Evaluation of Accelerated Bachmann Bundle Area Pacing in Heart Failure With Reduced ejectIon Fraction Who Have electrocarDioGraphic Evidence of Interatrial Block and Indicated for Implantable Cardioverter Defibrillator
To evaluate the effect of accelerated atrial resynchronization achieved through Bachmann bundle pacing at the time of implantable cardioverter-defibrillator implantation in patients with heart failure with reduced ejection…
- Trial name
- BRIDGE-HF (NCT07547306)
- Testing
- BBAP on, BBAP off, RAAP
- Volunteers
- 120 people
- Sponsor
- Seoul National University Hospital
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
Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and…
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree, Heart Failure
- Trial name
- CIED-CARE (NCT06652750)
- Testing
- Routine Management, 5G Cloud Follow-up
- Where
- 2 sites in China
- Volunteers
- 688 people
- Sponsor
- The Third People's Hospital of Chengdu
HFrEF - Heart Failure With Reduced Ejection Fraction, HFmrEF
Coffee Use, Physical Activity and Symptomatic Ventricular Arrhythmias in Patients With Left Ventricular Dysfunction and an ICD
The goal of this observational study is to learn whether caffeine consumption is associated with ventricular arrhythmias and physical activity in adults with heart failure, reduced left ventricular ejection fraction, and an…
- Conditions
- HFrEF - Heart Failure With Reduced Ejection Fraction, HFmrEF, Ventricular Arrhythmia, ICD
- Trial name
- CUPS-ICD (NCT07823998)
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 170 people
- Sponsor
- Jean-Benoît Le Polain de Waroux
Tachycardia, Heart Failure
BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family
The goal of this exploratory study is to test the preliminary safety and product performance of the new CorSky ICD family in subjects that require an ICD or cardiac resynchronization therapy with defibrillation (CRT-D).
- Trial name
- NCT06840509
- Testing
- CorSky ICD or CRT-D
- Where
- Australia
- Volunteers
- 52 people
- Sponsor
- Biotronik Australia Pty Ltd.
Heart Failure
RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
BRITISH is a UK multicentre trial of patients who have been diagnosed with heart failure due to Non-Ischemic Cardiomyopathy (NICM, or heart failure that is not caused by blocked heart arteries.
- Trial name
- BRITISH (NCT05568069)
- Testing
- Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
- Where
- 47 sites in United Kingdom
- Volunteers
- 2,504 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Ventricular Tachycardia, Coronary Artery Disease
Coronary Flow During Rapid Heart Rates
The goal of this observational study is to learn about the factors which determine how well ventricular tachycardia (VT) is tolerated. The main questions it aims to answer are: 1.
- Conditions
- Ventricular Tachycardia, Coronary Artery Disease, Heart Failure, Coronary Microvascular Dysfunction
- Trial name
- VT flow (NCT05841199)
- Testing
- Pressure and flow measurement during simulated VT
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- Imperial College London
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
Heart Failure
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.
- Trial name
- DANLOGIC-HF (NCT06099158)
- Testing
- HeartLogic
- Where
- 5 sites in Denmark
- Volunteers
- 1,428 people
- Sponsor
- Tor Biering-Sørensen
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