Clinical trials: Ventricular Tachyarrhythmia
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
Ventricular Tachyarrhythmia, Ventricular Arrythmia
Ventricular Catheter Ablation Study (VCAS)
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce™ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex…
- Conditions
- Ventricular Tachyarrhythmia, Ventricular Arrythmia, PVC - Premature Ventricular Complex, PVC - Premature Ventricular Contraction
- Trial name
- VCAS (NCT06203262)
- Testing
- FieldForce™ Ablation System Ventricular Tachycardia, FieldForce™ Ablation System Premature Ventricular Contractions
- Where
- 2 sites in Czechia
- Volunteers
- 34 people
- Sponsor
- Field Medical
Tachyarrhythmias, Heart Failure
ConsultaTM CRT-D Clinical Evaluation Study
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00526162
- Testing
- Bi-ventricular Implantable Cardioverter Defibrillator
- Where
- Germany
- Volunteers
- 83 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachyarrhythmias
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system.
- Trial name
- Chronic II (NCT00853645)
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) System
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Boston Scientific Corporation
Tachyarrhythmias, Heart Failure
Safety and Clinical Performance of the Protecta ICD and CRT-D
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic…
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00982397
- Testing
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- Where
- 122 sites in United States, Austria and 19 more
- Volunteers
- 2,770 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacing, Electric Countershock
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function.
- Conditions
- Cardiac Pacing, Electric Countershock, Ventricular Tachyarrhythmia
- Trial name
- ANVITE (NCT00858559)
- Testing
- Implantable cardioverter defibrillator with Home Monitoring function, Standard implantable cardioverter defibrillator
- Where
- Germany
- Volunteers
- 110 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Tachyarrhythmia
NORDIC ICD (Cardioverter Defibrillator Implantation) Trial
The purpose of the NORDIC ICD study is to evaluate whether ICD implantation without intra-operative DF testing is non-inferior to ICD implantation with intra-operative DF testing regarding the efficacy of the first ICD shock for…
- Trial name
- NCT01282918
- Testing
- ICD implantation w/o DF test, ICD implantation with DF test
- Where
- 2 sites in Germany, Sweden
- Volunteers
- 1,077 people
- Sponsor
- Biotronik SE & Co. KG
Tachyarrhythmia
Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA)
A unique single-lead dual-chamber implantable cardioverter-defibrillator (ICD) system (produced by Biotronik, Germany) features a conventional electrode in the ventricle (anchored in the ventricular apex) and a floating electrode…
- Trial name
- NCT00324662
- Testing
- Implantable cardioverter-defibrillator
- Where
- 10 sites in Germany, Switzerland
- Volunteers
- 260 people
- Sponsor
- Biotronik SE & Co. KG