Clinical trials: Implantable Cardiac Defibrillator
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
Heart Failure, Cardiomyopathy
Correlating QLV Interval to Left Ventricular (LV) Lead Position in Patients Receiving Cardiac Resynchronization Therapy.
This is a prospective clinical trial to determine the optimal QLV interval during implantation to achieve the best possible response from cardiac resynchronization therapy for heart failure patients.
- Conditions
- Heart Failure, Cardiomyopathy, Cardiac Arrhythmia
- Trial name
- QLV (NCT02166762)
- Testing
- QLV interval measurement
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Diego
Heart Failure, Coronary Artery Disease
Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant
The purpose of this study is to determine whether it is safe to send patients home from the hospital on the same day following an implantable cardioverter defibrillator (ICD) implant.
- Trial name
- SDD for ICD (NCT01993862)
- Testing
- Same Day Discharge
- Where
- 28 sites in United States
- Volunteers
- 266 people
- Sponsor
- Abbott Medical Devices
Arrhythmia
SOFA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia
The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an…
- Trial name
- NCT00110838
- Where
- 27 sites in Austria, Belgium and 6 more
- Volunteers
- 546 people
- Sponsor
- Wageningen Centre for Food Sciences
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
Heart Failure, Left Bundle-Branch Block
Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication
Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately…
- Trial name
- CRTICD Dual LV (NCT01415024)
- Testing
- second LV lead in CRT
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Schuechtermann-Klinik
Non-ischemic Dilated Cardiomyopathy
Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care…
- Trial name
- CMR-ICD (NCT04558723)
- Testing
- ICD/CRT-D implantation
- Where
- Germany
- Volunteers
- 760 people
- Sponsor
- Prof. Dr. med. Ingo Eitel
Congestive Heart Failure (CHF)
Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump…
- Trial name
- NCT00528320
- Testing
- Ovatio CRT
- Sponsor
- ELA Medical, Inc.
Ventricular Arrhythmias
Antiarrhythmic Effects of Spironolactone in Patients With ICDs
This study will test whether spironolactone, an approved drug for among other things hypertension, will reduce the risk of severe arrhythmias in patients with implanted defibrillators.
- Trial name
- SPIRIT (NCT04495712)
- Testing
- spironolactone
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- VA Office of Research and Development
Congestive Heart Failure, Coronary Artery Disease
Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function.
- Conditions
- Congestive Heart Failure, Coronary Artery Disease, Myocardial Infarction
- Trial name
- NCT00050765
- Testing
- MyoCell™ Autologous Myoblasts
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Bioheart, Inc.
Heart Failure, Tachycardia, Ventricular
Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators
This observational protocol will evaluate the effects of monopolar electrocautery (ME) on implantable cardioverter defibrillators (ICDs) in patients undergoing surgery.
- Trial name
- NCT01572246
- Testing
- Optimal placement of return pad
- Where
- United States
- Volunteers
- 167 people
- Sponsor
- Oregon Health and Science University
Congestive Heart Failure
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device.
- Trial name
- CLEPSYDRA (NCT00957541)
- Testing
- Paradym CRT + Physiological Diagnosis (PhD)
- Where
- United States
- Volunteers
- 520 people
- Sponsor
- ELA Medical, Inc.
Heart Failure
Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing
The purpose of this clinical study is to determine the optimal imaging parameters and assess the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.
- Trial name
- LMI1195-201 (NCT01085175)
- Testing
- LMI 1195
- Where
- United States
- Sponsor
- Lantheus Medical Imaging
CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC
Perioperative Management of Patients With Cardiac Implantable Electronic Devices
Data on the perioperative management of patients cardiac implantable electronic devices (CIEDs) is limited and published guidelines rely mainly on the experience of the cardiologists and anesthesiologists who manage these…
- Trial name
- MAGNET (NCT02025738)
- Testing
- MAGNET APPLICATION, REPROGRAMING, NO ACTION
- Where
- Israel
- Volunteers
- 150 people
- Sponsor
- Rambam Health Care Campus
Infarction, Myocardial
Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction
Sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (LVEF).
- Trial name
- WICD-MI (NCT05123885)
- Testing
- Study on Data
- Where
- 40 sites in France
- Volunteers
- 1,032 people
- Sponsor
- Mathieu ECHIVARD
Heart Diseases
A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators
Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators
- Trial name
- NCT00162448
- Testing
- BMS-394136
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Bristol-Myers Squibb
Heart Failure
REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor
However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is…
- Trial name
- REMOTE-HEART (NCT06173089)
- Testing
- Remote monitoring
- Where
- Hungary
- Volunteers
- 800 people
- Sponsor
- Semmelweis University Heart and Vascular Center
Heart Failure, Sudden Cardiac Death
Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
S-ICD avoids the use intravascular leads and their associated risks, has been increasingly used for primary and secondary prevention of sudden death.
- Conditions
- Heart Failure, Sudden Cardiac Death, Ventricular Tachycardia
- Trial name
- NCT04127643
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Yonsei University
Ventricular Tachycardia, Ischemic
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic…
- Trial name
- ASPIRE (NCT01557842)
- Testing
- Drug Treatment, Catheter Ablation
- Where
- 23 sites in United States
- Volunteers
- 15 people
- Sponsor
- Biosense Webster, Inc.
Tachyarrhythmias, Sudden Cardiac Death
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT00940888
- Testing
- SJ4 connector and RV high voltage SJ4 lead
- Where
- United States
- Volunteers
- 1,701 people
- Sponsor
- Abbott Medical Devices