Clinical trials: ICD Malfunction
Heart Disease, Cardiovascular Disease
Remote Device Interrogation In The Emergency Department
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REMEDY (NCT01871090)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
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
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
Heart Diseases
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.
- Trial name
- NCT00328705
- Testing
- Implantable Cardioverter Defibrillator
- Where
- 5 sites in United States
- Volunteers
- 65 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia, Congestive Heart Failure
MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
The MADIT-CRT trial is designed to determine if combined implantable cardiac defibrillator (ICD)-cardiac resynchronization therapy (CRT-D) will reduce the risk of mortality and heart failure (HF) events by approximately 25%, in…
- Trial name
- MADIT-CRT (NCT00180271)
- Testing
- Cardiac resynchronization therapy with defibrillation, Implantable Cardioverter Defibrillator (ICD)
- Where
- United States
- Volunteers
- 1,820 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Tachycardia, Ventricular
Optisure Lead Post Approval Study
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.
- Trial name
- NCT02235545
- Testing
- St. Jude Medical Optisure Lead
- Where
- 60 sites in United States, Belgium and 5 more
- Volunteers
- 1,735 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Tachyarrhythmia
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by demonstrating clinical safety evaluating performance based…
- Trial name
- NCT05621187
- Testing
- Pamira ICD lead family
- Where
- 23 sites in Australia, Austria and 6 more
- Volunteers
- 221 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Congestive
Multiple Cardiac Sensors for the Management of Heart Failure
The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.
- Trial name
- MANAGE-HF (NCT03237858)
- Testing
- HeartLogic ON, HeartLogic OFF
- Where
- 30 sites in United States, France and 1 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Sudden Cardiac Death
Longitudinal Surveillance Registry
Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active ongoing source of updated information on the long-term reliability and performance of BSC commercially available leads and LATITUDE-enabled…
- Trial name
- LSR (NCT00636272)
- Volunteers
- 2,500 people
- Sponsor
- Boston Scientific Corporation
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
Heart Failure, Arrhythmias, Cardiac
Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II)
The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology.
- Trial name
- HomeCARE II (NCT00711360)
- Testing
- Intrathoracic impedance measurement
- Where
- 28 sites in Germany, Spain and 1 more
- Volunteers
- 303 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Tachyarrhythmia
Iperia/Sentus QP Study
The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.
- Trial name
- NCT02181686
- Where
- 24 sites in Austria, Denmark and 9 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
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