Clinical trials: ICD Indication
Cardiopulmonary Failure, Myocardial Infarction (MI)
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using…
- Conditions
- Cardiopulmonary Failure, Myocardial Infarction (MI), Heart Decompensation, Heart Failure
- Trial name
- COR-INSIGHT (NCT06763549)
- Testing
- SUBPROTOCOL A, SUBPROTOCOL B, SUBPROTOCOL C
- Where
- United States
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Implantable Cardiac Device. Patients With a NMR Indication
Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance
The general objective of this registry is to study the number of patients carrying an implantable cardiac device that have an indication for an imaging diagnosis based on nuclear magnetic resonance.
- Trial name
- RESONANCE (NCT04330898)
- Testing
- Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers
- Where
- 20 sites in Spain
- Volunteers
- 1,248 people
- Sponsor
- Trialance SCCL
Cardiac Death
Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients
The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prevention ICD indication.
- Trial name
- DECREASE (NCT01217528)
- Testing
- device settings for group A, Device settings for group B
- Where
- 34 sites in Germany
- Volunteers
- 543 people
- Sponsor
- Abbott Medical Devices
Sudden Cardiac Death
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
- Trial name
- Prediction (NCT00560768)
- Testing
- Ovatio VR 6250 or DR6550
- Where
- 30 sites in United States, Canada and 2 more
- Volunteers
- 198 people
- Sponsor
- LivaNova
Tachyarrhythmias, Atrial Fibrillation
OptiSense™ Performance in Detecting Atrial Episodes
The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW).
- Trial name
- SENSE-AF (NCT00870324)
- Testing
- OptiSense Lead, Tendril Lead
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Cardiac Disease
Lumax DX / Linox DX Evaluation
The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system. No hypothesis has been defined.
- Trial name
- NCT01486836
- Where
- Germany
- Volunteers
- 38 people
- Sponsor
- Biotronik SE & Co. KG
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
Defibrillators, Tachycardia
Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation
Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring…
- Trial name
- Educ@t (NCT01006746)
- Testing
- Remote monitoring by Home Monitoring system
- Where
- France
- Volunteers
- 571 people
- Sponsor
- Biotronik France
Heart Failure, Arrhythmias, Cardiac
Heart Failure and Sudden Cardiac Death Japan Registry
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart…
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
- Trial name
- HINODE (NCT03185832)
- Testing
- CRT-D, ICD, PM / CRT-P
- Where
- 34 sites in Japan
- Volunteers
- 354 people
- Sponsor
- Boston Scientific Corporation
Congestive Heart Failure, Cardiac Resynchronization Therapy
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up treatment of patients implanted…
- Trial name
- NCT00395642
- Testing
- Kronos LV-T, Lumax HF-T
- Where
- 12 sites in United States
- Volunteers
- 66 people
- Sponsor
- Biotronik, Inc.
Primary Prevention, Tachycardia, Ventricular
Survival of Patients With Primary Prophylactic ICD Indication
The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD).
- Conditions
- Primary Prevention, Tachycardia, Ventricular, Sudden Cardiac Death
- Trial name
- SPIRIT-ICD (NCT00619593)
- Testing
- Intensified diagnostic and treatment measures following 1st appropriate ICD therapy, Standard follow-up
- Where
- 37 sites in Austria, Czechia and 9 more
- Volunteers
- 504 people
- Sponsor
- Biotronik SE & Co. KG
ICD/CRT-D Indication
TD01 Master Study (Safety and Efficacy Study)
This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.
- Trial name
- NCT02087189
- Testing
- First ICD/CRT-D implantation or upgrade from pacemaker
- Where
- 5 sites in Austria, Germany
- Volunteers
- 30 people
- Sponsor
- Biotronik SE & Co. KG
Patients With an Indication for an ICD Implantation According to the Guidelines
Protecta Smart Analysis Register
ProSA is a prospective, non-randomized, multicenter, observational study investigating the utilization and effectiveness of the Smart Shock™ algorithm in ICD patients treated with a Protecta™, Protecta™ XT or any equivalent…
- Trial name
- ProSA (NCT01714921)
- Volunteers
- 504 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and…
- Trial name
- OPTION (NCT00729703)
- Testing
- Ovatio DR 6550
- Where
- 55 sites in United States, Belgium and 7 more
- Volunteers
- 462 people
- Sponsor
- LivaNova
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure.
- Trial name
- NCT01117792
- Testing
- subcutaneous implantable defibrillator (S-ICD) system
- Where
- 8 sites in Italy, Netherlands and 2 more
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
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
ICD Indication
Linox Smart S DX PME/Master Study
The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.
- Trial name
- NCT01090401
- Testing
- Linox smart S DX
- Where
- Germany
- Volunteers
- 116 people
- Sponsor
- Biotronik SE & Co. KG
Shock
Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication
Although shock therapy is effective in terminating ventricular tachycardia (VT), it can be painful to the patient and repetitive shocks can decrease a patient's quality of life.
- Trial name
- PROVIDE (NCT00743522)
- Testing
- ICD/ CRT-D
- Where
- United States
- Volunteers
- 1,670 people
- Sponsor
- Abbott Medical Devices