Clinical trials: ICD
Heart Failure, Ischemic Cardiomyopathy
18F-mFBG Imaging for Myocardial Sympathetic Innervation
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation.
- Conditions
- Heart Failure, Ischemic Cardiomyopathy, ICD Patients
- Trial name
- NCT06965621
- Testing
- 18F-metaFluorobenzylguanidine, Rubidium-82
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Implantable Cardioverter Defibrillator(ICD)
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy
- Trial name
- BIO|ATP (NCT05426785)
- Testing
- 1:1 ratio for Treatment Group and Control Group
- Where
- Japan
- Volunteers
- 398 people
- Sponsor
- Biotronik SE & Co. KG
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
Ventricular Arrythmia, Lead
Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR)
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Trial name
- APOLLO (NCT04590144)
- Testing
- INVICTA lead
- Where
- 45 sites in Austria, France and 6 more
- Volunteers
- 446 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
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
Candidal Vulvovaginitis (ICD-10 Code: B37.3), Vulvovaginal Candidiasis (VVC)
Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis.
- Trial name
- NCT06835361
- Testing
- Clotrimazole+Lactulose., Canesten (Clotrimazole), Lactulose
- Where
- 7 sites in Belarus, Russia
- Volunteers
- 264 people
- Sponsor
- AVVA Pharmaceuticals Ltd.
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
ICD, Tachycardia
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.
- Trial name
- ASIA MRI ICD (NCT02877693)
- Testing
- Thoracic MRI Scan
- Where
- 20 sites in India, Malaysia and 1 more
- Volunteers
- 205 people
- Sponsor
- Abbott Medical Devices
Inappropriate Shocks From Implanted Defibrillator, ICD Replacement or Upgrade
Observational Study on Inappropriate Therapies
The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)
- Trial name
- OSIRIS (NCT04118803)
- Testing
- ICD replacement or upgrade
- Where
- 58 sites in United States, Austria and 9 more
- Volunteers
- 881 people
- Sponsor
- MicroPort CRM
Advanced Heart Failure, CRT and/or ICD
Screening for Advanced Heart Failure Treatment (SEE-HF)
Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with…
- Trial name
- SEE-HF (NCT01626404)
- Where
- 7 sites in Denmark, France and 4 more
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
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
ICD, Cardiomyopathy Ischemic
Assessment of Risk Factors for Appropriate ICD (Implantable Cardioverter-defibrillator) Intervention in Patients With Ischemic Cardiomyopathy
Design: PARCADIA is a prospective non-randomized non-interventional multi-center clinical investigation in Europe. Patients with depressed LV (left ventricular) function assessed on local standards, of ischemic origin and on…
- Conditions
- ICD, Cardiomyopathy Ischemic, Primary Prevention
- Trial name
- PARCADIA (NCT04014946)
- Testing
- ICD implantation
- Volunteers
- 200 people
- Sponsor
- Biotronik SE & Co. KG
Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection
Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection
- Trial name
- PREVENT-DX (NCT04344704)
- Testing
- Single chamber DAI device with floating atrial dipole
- Where
- 16 sites in Spain
- Volunteers
- 462 people
- Sponsor
- Trialance SCCL
Ventricular Arrythmia, Lead
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE…
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Trial name
- FRIENDS (NCT03766919)
- Testing
- Implant of the INVICTA lead
- Where
- 10 sites in France, Italy and 2 more
- Volunteers
- 33 people
- Sponsor
- MicroPort CRM
Patients Indicated for an ICD
Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
The objective of this study is to confirm the long-term safety and reliability of the Linox Lead System as used with BIOTRONIK ICDs.
- Trial name
- GALAXY (NCT00836589)
- Testing
- ICD Therapy - ICD Lead Registry
- Where
- 85 sites in United States
- Volunteers
- 1,997 people
- Sponsor
- Biotronik, Inc.
Persistent Atrial Fibrillation, Heart Failure
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent or longstanding persistent atrial fibrillation, low LVEF and requiring ICD or CRT-D…
- Conditions
- Persistent Atrial Fibrillation, Heart Failure, ICD
- Trial name
- AMICA (NCT00652522)
- Testing
- ICD/CRT implant, AF ablation, Best Medical Treatment
- Where
- 16 sites in Germany, Hungary and 1 more
- Volunteers
- 202 people
- Sponsor
- Abbott Medical Devices
The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision
St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.
- Trial name
- REACT (NCT01090349)
- Testing
- Implantation of an ICD/CRT-D device, Merlin.NET PCN
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 220 people
- Sponsor
- Abbott Medical Devices
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
ICD, Sudden Cardiac Death
Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
The purpose of the THORN registry is to show the ability of Home-Monitoring® to early identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients (i.e.
- Conditions
- ICD, Sudden Cardiac Death, Ventricular Fibrillation, Atrial Fibrillation
- Trial name
- THORN (NCT01594112)
- Where
- 55 sites in France
- Volunteers
- 512 people
- Sponsor
- Biotronik SE & Co. KG
ICD and CRT-D Indicated Patients
The 4-SITE Field Following Study (4-SITE FF)
The purpose of this study is to evaluate and document appropriate clinical performance of the new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable cardioverter defibrillator (ICD) PGs (Models…
- Trial name
- 4-SITE FF (NCT00920452)
- Where
- Germany
- Volunteers
- 430 people
- Sponsor
- Guidant Corporation