Clinical trials: Implantable Cardiac Defibrillator
Heart Failure
OptiVol® Care Pathway
Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States.
- Trial name
- NCT00847288
- Testing
- Monthly Review Arm, Quarterly Review Arm
- Where
- 108 sites in United States
- Volunteers
- 1,682 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Persistent Atrial Fibrillation, Cardiac Arrhythmia
Investigation of Therapeutic Ablation Versus Cardioversion for AF
The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with cryoablation for atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion…
- Trial name
- ORBITA-AF (NCT03907982)
- Testing
- DC Cardioversion, Pulmonary vein isolation, Implantable loop recorder
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Barts & The London NHS Trust
Heart Failure, Ventricular Dysfunction
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients
The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients…
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Diseases
- Trial name
- NCT00187213
- Testing
- Cardiac Resynchronization Therapy
- Where
- France
- Sponsor
- Abbott Medical Devices
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.
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.
Heart Failure, Obesity
Safety of Body Composition Analysis in Heart Failure Patients With Implantable Cardioverter Defibrillators (ICDs)
The purpose of this study is to define the safety of using bioimpedance for analysis of body composition in heart failure patients with ICD devices.
- Trial name
- NCT01568606
- Testing
- Body Composition Analysis InBody Scale
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Los Angeles
Heart Failure, Sudden Cardiac Death
Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators
The EVOLVO study is designed to compare the remote defibrillator management to the current standard of care, to assess its ability to treat and triage patients more effectively.
- Conditions
- Heart Failure, Sudden Cardiac Death, Implantable Defibrillator
- Trial name
- EVOLVO (NCT00873899)
- Testing
- The Medtronic CareLink system (Minneapolis, MN, USA).
- Where
- 6 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Regione Lombardia
Diabetes Mellitus, Heart Failure
Sodium-glucose Co-transporter 2 Inhibitors Effects in Failing Heart Patients
SLGT2 therapy is safety used in heart failure (HF) patients with depressed left ventricle ejection fraction (LVEF) and diabetes mellitus (DM).
- Conditions
- Diabetes Mellitus, Heart Failure, Ventricular Arrythmia
- Trial name
- NCT03977116
- Testing
- SLGT2
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- University of Campania Luigi Vanvitelli
Wound, Cardiac Arrhythmia
ZIPS Study - Zip Incision aPproximation vs. Suture
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.
- Trial name
- ZIPS (NCT02213510)
- Testing
- Zip Surgical Skin Closure Device, Standard Suture Closure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
Arrhythmias, Cardiac, Atrioventricular Block
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical…
- Conditions
- Arrhythmias, Cardiac, Atrioventricular Block, Reduced Systolic Function, Atrial Fibrillation
- Trial name
- TREEBEARD (NCT06324682)
- Testing
- Cardiac pacing - Conventional RV pacing, Cardiac pacing - Conduction System Pacing, Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)
- Where
- 31 sites in Italy
- Volunteers
- 8,400 people
- Sponsor
- University Hospital of Ferrara
Coronary Heart Disease, Congestive Heart Failure
Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death
Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF < 40%.
- Conditions
- Coronary Heart Disease, Congestive Heart Failure, Ventricular Dysfunction, Low Cardiac Output
- Trial name
- SMART-ICD (NCT00524862)
- Testing
- Optimized medical therapy, Implantable Cardioverter Defibrillator
- Where
- 10 sites in Canada
- Volunteers
- 5,000 people
- Sponsor
- Unity Health Toronto
Prosthesis-Related Infections, Equipment Failure
Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers
The growing use and the expanding indications for cardiovascular implantable electronic devices (CIEDs) have been associated to an increase of device removal.
- Conditions
- Prosthesis-Related Infections, Equipment Failure, Heart Failure, Arrhythmias
- Trial name
- GAINE LASER (NCT03121183)
- Testing
- Laser sheath, Implantable Cardiac Device lead extraction
- Where
- France
- Volunteers
- 45 people
- Sponsor
- University Hospital, Clermont-Ferrand
Sleep Apnea, Arrhythmias
Automate Detection of Sleep Apnea by ApneascanTM
The purpose of the study is to compare, three months after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), the apnea-hypopnea index (AHI) obtained from conventional in-lab…
- Trial name
- AIRLESS (NCT02045173)
- Testing
- Apneascan TM, Polysomnography/polygraphy
- Where
- 5 sites in France
- Volunteers
- 41 people
- Sponsor
- University Hospital, Grenoble
Chronic Heart Failure
A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)
Researchers are looking for a better way to treat people who have chronic heart failure. Chronic heart failure is a medical condition with shortness of breath, tiredness and ankle swelling in which the heart does not pump blood…
- Trial name
- REMOTE-HF (NCT05532046)
- Testing
- BAY2413555 Dose 1, BAY2413555 Dose 2
- Where
- 18 sites in United States, Denmark and 4 more
- Volunteers
- 22 people
- Sponsor
- Bayer
Heart Failure
CareLink® Network Evaluation
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
- Trial name
- NCT01023022
- Testing
- Medtronic CareLink® Network
- Where
- 10 sites in Poland
- Volunteers
- 176 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
ProMRI PROVEN Master Study
This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker…
- Trial name
- NCT01809665
- Testing
- ICD/CRT-P therapy, MRI
- Where
- 23 sites in Australia, Austria and 6 more
- Volunteers
- 174 people
- Sponsor
- Biotronik SE & Co. KG
Sudden Cardiac Death
Study of Paced QRS Duration as a Marker of Sudden Cardiac Death
The purpose of the study is to determine whether prolonged paced QRS duration is a marker of sudden cardiac death in subjects with implantable cardioverter-defibrillators (ICD).
- Trial name
- NCT01948206
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Pocono Medical Center
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
Arrhythmias, Cardiac
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
- Trial name
- NCT01130896
- Where
- United States
- Volunteers
- 1,509 people
- Sponsor
- Johns Hopkins University
Cognitive Impairment, Cognitive Change
How is COGNItive Function Affected by Cardiac Resynchronisation Therapy?
The primary objective of COGNI-CRT is to assess whether Cardiac Resynchronisation Therapy (CRT) can improve cognitive function in patients with systolic HF (LVEF ≤35%), when compared to a control group of patients implanted with…
- Conditions
- Cognitive Impairment, Cognitive Change, Heart Failure, Systolic, Heart Failure
- Trial name
- COGNI-CRT (NCT03755570)
- Testing
- Repeatable Assessment of Neuropsychological Status, Hospital Anxiety and Depression Scale, Frontal Assessment Battery
- Where
- United Kingdom
- Volunteers
- 198 people
- Sponsor
- Royal Cornwall Hospitals Trust