Clinical trials: Tachyarrhythmias
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
Tachyarrhythmias
SecuraTM ICD Clinical Evaluation Study
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
- Trial name
- NCT00526227
- Testing
- Secura ICD
- Where
- 13 sites in Austria, Finland and 5 more
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachyarrhythmia, Arrhythmias, Cardiac
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and…
- Trial name
- NCT03408951
- Testing
- Recording
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- NewPace Ltd
Heart Failure, Tachyarrhythmia
BIO|MASTER.Ilivia Family / Plexa
Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region
- Trial name
- NCT02774616
- Testing
- Ilivia ICD Family, Plexa ICD lead
- Where
- 25 sites in Australia, Austria and 8 more
- Volunteers
- 292 people
- Sponsor
- Biotronik SE & Co. KG
Tachyarrhythmias, Syncope
Study of New Implantable Loop Recorder
The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).
- Trial name
- NCT00746564
- Testing
- SJM Confirm
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Abbott Medical Devices
Tachyarrhythmia
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to…
- Trial name
- NCT00170274
- Testing
- Activation of preventive and therapeutic algorithms for treatment of AF, AF Prevention and Therapy Algorithms On
- Where
- 6 sites in Germany
- Volunteers
- 156 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiovascular Diseases
Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation
The MANDATE-AF study was designed to address evidence needs in India for device-based management of AF using AT/AF (Atrial Tachycardia/Atrial fibrillation) diagnostic features and therapies such as Reactive Atrial anti…
- Trial name
- MANDATE-AF (NCT04172883)
- Testing
- Treatment arm
- Where
- 11 sites in India
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmia
Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease
The purpose of this study is to learn the effects of a test drug on heart rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe.
- Trial name
- NCT00137332
- Testing
- GAP-486 (ZP-123), 0.9% Sodium Chloride, USP
- Where
- 33 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Postoperative Supraventricular Tachyarrythmia
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy and safety in patients with postoperative supraventricular tachyarrhythmias.
- Trial name
- NCT00212680
- Testing
- ONO-1101
- Volunteers
- 100 people
- Sponsor
- Ono Pharma USA Inc
Arrhythmia, Quality of Life
Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies.
- Trial name
- NCT00325221
- Testing
- HM on, HM Off
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 148 people
- Sponsor
- Biotronik SE & Co. KG
Tachyarrhythmia, Heart Failure
BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs
The CorSky family is BIOTRONIK´s new generation of ICDs. They are the successor devices of the current Acticor/Rivacor family and inherit all iShock/iShock_BC (Ilivia Neo, Intica Neo) implant and programmer software features.
- Trial name
- NCT07360158
- Testing
- CorSky ICD or CRT-D
- Where
- 7 sites in Austria, Czechia and 2 more
- Volunteers
- 151 people
- Sponsor
- Biotronik SE & Co. KG
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
Tachyarrhythmia
ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations
The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of…
- Trial name
- NCT00231426
- Testing
- ICD
- Where
- United States
- Sponsor
- Boston Scientific Corporation
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
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 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, Atrial Fibrillation (AF)
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk…
- Conditions
- Tachyarrhythmia, Atrial Fibrillation (AF), Syncope, Cryptogenic Stroke
- Trial name
- NCT04025710
- Testing
- BIOMONITOR III and BIOMONITOR IIIm
- Where
- 27 sites in Australia, Austria and 4 more
- Volunteers
- 167 people
- Sponsor
- Biotronik SE & Co. KG
Tachyarrhythmia
ProMRI ICD/CRT-D Post Approval Study
Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.
- Trial name
- NCT02933619
- Volunteers
- 24,249 people
- Sponsor
- Biotronik, Inc.
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
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