Clinical trials: Defibrillation
Ventricular Arrhythmia, Ventricular Tachycardia
Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study
The PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely…
- Conditions
- Ventricular Arrhythmia, Ventricular Tachycardia, Ventricular Fibrillation
- Trial name
- PASS PULL (NCT05099289)
- Testing
- AtaCor EV-ICD Lead
- Where
- Paraguay
- Volunteers
- 18 people
- Sponsor
- AtaCor Medical, Inc.
Tachyarrhythmia
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD…
- Trial name
- NCT04863664
- Testing
- Defibrillation (RV Implant), Defibrillation (LBBAP Implant)
- Where
- 55 sites in United States, Australia and 18 more
- Volunteers
- 998 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmia
Observation of ImageReady™ MR Conditional Defibrillation System in China
To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.
- Trial name
- NCT03451721
- Testing
- ImageReady™ MR Conditional Defibrillation System
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
COlchicine for the Prevention of Post Electrical Cardioversion Recurrence of AF
There is substantial evidence linking inflammation to the initiation and perpetuation of AF. Although the precise mechanism by which inflammation contributes to the development of AF remains unclear, it has been proposed that…
- Trial name
- COPPER-AF (NCT02582190)
- Testing
- Colchicine group
- Sponsor
- Elpen Pharmaceutical Co. Inc.
Heart Failure, Heart Failure With Reduced Ejection Fraction
Assessment of Combined CCM and ICD Device in HFrEF
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy
- Trial name
- INTEGRA-D (NCT05855135)
- Testing
- OPTIMIZER® Integra CCM-D System (Treatment Arm)
- Where
- 59 sites in United States
- Volunteers
- 300 people
- Sponsor
- Impulse Dynamics
Tachycardia, Ventricular Fibrillation
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
- Conditions
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
- Trial name
- NCT01856491
- Testing
- RELIANCE 4-FRONT™ Passive Fixation lead implantation
- Where
- 11 sites in Germany, Israel and 1 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm).
- Trial name
- X-VERT (NCT01674647)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonist (VKA)
- Where
- 178 sites in United States, Belgium and 15 more
- Volunteers
- 1,504 people
- Sponsor
- Bayer
Arrythmia, Implatable Cardioverter Defibrillation, Lead
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped\&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT)…
- Trial name
- NAVIGATOR (NCT03279484)
- Testing
- NAVIGO 4LV lead implant
- Where
- 38 sites in France, Germany and 4 more
- Volunteers
- 317 people
- Sponsor
- MicroPort CRM
Monomorphic Ventricular Tachycardia
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St.
- Trial name
- EPIC (NCT02584595)
- Testing
- ICD/CRT-D with NIPS or EP Study
- Sponsor
- Abbott Medical Devices
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
Tachycardia, Ventricular Arrhythmias
Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.
- Trial name
- NCT02772380
- Testing
- Defibrillation following induction of VT/VF
- Where
- 36 sites in United States, Australia and 10 more
- Volunteers
- 87 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Arrhythmias
Acute Defibrillation Study
The proposed study is designed to characterize defibrillation efficacy in humans for the potential development of a new extravascular implantable cardioverter defibrillator (ICD) system.
- Trial name
- NCT02227121
- Testing
- Defibrillation following induction of VT/VF
- Where
- 7 sites in Hong Kong, Netherlands and 2 more
- Volunteers
- 16 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305
This study is being carried out to see which dose of AZD1305 is safe and effective in cardioverting atrial fibrillation into normal heart rhythm.
- Trial name
- NCT00915356
- Testing
- AZD1305
- Where
- 31 sites in Czechia, Denmark and 6 more
- Volunteers
- 228 people
- Sponsor
- AstraZeneca
Atrial Fibrillation
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation
This was a randomized, placebo-controlled, investigator- and participant-blinded study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of HSY244 in participants with atrial fibrillation (AF), with and…
- Trial name
- NCT04582409
- Testing
- HSY244
- Where
- 4 sites in United States, Germany
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Persistent Atrial Fibrillation
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.
- Trial name
- ReMATCH (NCT06735534)
- Testing
- FARAPULSE™ Pulsed Field Ablation System
- Where
- 41 sites in United States, Australia and 1 more
- Volunteers
- 376 people
- Sponsor
- Boston Scientific Corporation
Ventricular Tachycardia, Ventricular Fibrillation
Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead
The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle
- Trial name
- NCT00180297
- Testing
- Endotak Reliance G
- Where
- 18 sites in France
- Volunteers
- 215 people
- Sponsor
- Boston Scientific Corporation
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
Ventricular Fibrillation
Acute Feasibility Investigation of a New S-ICD Electrode
This is an early-stage feasibility study. This study seeks to characterize the performance of the new electrode shock configuration with the S-ICD
- Trial name
- ASE (NCT03802110)
- Testing
- commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
- Where
- 4 sites in Netherlands
- Volunteers
- 42 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)
Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that puts them at risk of developing clots in the heart.
- Trial name
- EMANATE (NCT02100228)
- Testing
- Apixaban, Parenteral heparin and/or oral Vitamin K antagonist
- Where
- 165 sites in United States, Belgium and 10 more
- Volunteers
- 1,500 people
- Sponsor
- Pfizer
Atrial Fibrillation
Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)
This non-interventional prospective study is a post-authorization safety study (PASS) of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically…
- Trial name
- NCT01370629
- Testing
- Vernakalant
- Where
- 6 sites in Austria, Denmark and 4 more
- Volunteers
- 2,015 people
- Sponsor
- Correvio International Sarl