Clinical trials: ICD Patients
Heart Failure, Ventricular Tachycardia
Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure
This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic…
- Conditions
- Heart Failure, Ventricular Tachycardia, Cardiac Desynchronization
- Trial name
- ConnectOptiVol (NCT00730548)
- Testing
- Device triggered remote telephone contact because of Care Alert
- Where
- Germany
- Volunteers
- 180 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Complication of Cardiac Defibrillator
Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients
The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy.
- Trial name
- TARIFF (NCT01075516)
- Where
- 6 sites in Italy
- Volunteers
- 209 people
- Sponsor
- Abbott Medical Devices
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
Monomorphic Ventricular Tachycardia
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St.
- Trial name
- EPIC (NCT02584595)
- Testing
- ICD/CRT-D with NIPS or EP Study
- Sponsor
- Abbott Medical Devices
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
Inherited Metabolic Diseases, Lysosomal Storage Disorders
ALD-101 Adjuvant Therapy of Unrelated Umbilical Cord Blood Transfusion (UCBT) in Patients With Inherited Metabolic Diseases
Eligible research subjects will receive an unrelated umbilical cord blood transfusion as a possible cure for their inherited metabolic disease.
- Conditions
- Inherited Metabolic Diseases, Lysosomal Storage Disorders, Peroxisomal Storage Diseases, Inborn Errors of Metabolism
- Trial name
- UCBT-002 (NCT00654433)
- Testing
- ALD-101
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Aldagen
Atrial Fibrillation, Tachycardia
Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
This is an observational registry study aiming to collect data on efficacy and safety of the single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up period is 24 months.
- Conditions
- Atrial Fibrillation, Tachycardia, ICD Therapy, Thromboembolic Events
- Trial name
- MATRIX (NCT01774357)
- Where
- Germany
- Volunteers
- 2,054 people
- Sponsor
- Biotronik SE & Co. KG
Sudden Cardiac Death, Heart Failure
Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study
This study has 2 purposes: The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these…
- Trial name
- NOTICE-HF (NCT01227785)
- Testing
- INCEPTA ICD or CRT-D
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Guidant Corporation
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
Arrythmia, Implantable Cardioverter Defibrillator
Clinical and Device Functional Assessment of Real World ICD Patients
The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF).
- Trial name
- CARAT (NCT02341768)
- Testing
- ICD
- Where
- 102 sites in Austria, Canada and 10 more
- Volunteers
- 2,056 people
- Sponsor
- MicroPort CRM
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
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.
Arrhythmias, Cardiac, Heart Diseases
Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)
This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter…
- Conditions
- Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Implantable Cardioverter Defibrillator
- Trial name
- SHIELD-2 (NCT01464476)
- Testing
- Azimilide Dihydrochloride
- Where
- 138 sites in United States, Belgium and 11 more
- Volunteers
- 240 people
- Sponsor
- Forest Laboratories
Sudden Cardiac Death
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of…
- Trial name
- APPRAISE ATP (NCT02923726)
- Testing
- Arm 1 (ATP+Shock), Arm 2 (shock only)
- Where
- 134 sites in United States, Austria and 6 more
- Volunteers
- 2,692 people
- Sponsor
- Boston Scientific Corporation
Ventricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled…
- Trial name
- NCT07585968
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 7 sites in United States
- Volunteers
- 260 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Heart Failure
INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems
It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization…
- Trial name
- InContact (NCT01200381)
- Testing
- Quarterly remote follow ups and remote monitoring, Quarterly remote follow ups + additional phone calls and remote monitoring, Quarterly in clinic follow ups and remote monitoring
- Where
- 17 sites in Germany
- Volunteers
- 210 people
- Sponsor
- Abbott Medical Devices
Heart Failure
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and…
- Trial name
- TRI-V (NCT00746135)
- Testing
- Device Implantation
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure, Coronary Artery Disease
MYOHEART™ (Myogenesis Heart Efficiency and Regeneration Trial)
The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure.
- Conditions
- Congestive Heart Failure, Coronary Artery Disease, Myocardial Infarction
- Trial name
- NCT00054678
- Testing
- MyoCell™, MyoCath™
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Bioheart, Inc.
Focus Whether After Implant Pre-AICD Video Was Helpful
LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator (AICD)
The purpose of this trial was to develop the initial sections of a video/DVD cassette that provided guidance about mastering stressful situations for patients who had been informed that they need an implantable…
- Trial name
- AICD (NCT01686490)
- Testing
- Video/workbook for patients about to receive an AICD, LiveSkills Video/Workbook for patients about to receive an AICD
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Williams LifeSkills
Healthy
Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants
The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in patients with right-sided implants.
- Trial name
- Tilt & Tune (NCT00873691)
- Testing
- ICD
- Where
- United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices