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.
Atrial Fibrillation
Atrial Fibrillation Detection Using Garmin Wearable Technology
The purpose of this study is to evaluate the feasibility of detecting atrial fibrillation (AF) in patients with AF using a wearable wrist device/smart watch.
- Trial name
- GARMIN AF (NCT03566836)
- Testing
- Garmin Smart Watch, Garmin Chest Band
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Kansas Medical Center
Atrial Fibrillation, Paroxysmal or Persistent
The SAFE Prospective Registry
Secretoneurin (SN) is a neuropeptide from the chromogranin family that influences intracellular calcium handling. SN suppresses calcium leakage from the sarcoplasmic reticulum through the ryanodine receptor.
- Trial name
- NCT05794464
- Testing
- Catheter ablation and/or electrical cardioversion
- Where
- Czechia
- Volunteers
- 60 people
- Sponsor
- University Hospital Ostrava
Cardiac Arrest
Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy
This study will compare the effect of constant low-level energy [150 joules] to an escalating energy [200-300-360 joules] regimen of biphasic waveform defibrillation on multiple patient outcomes.
- Trial name
- NCT00212992
- Testing
- Fixed lower-energy defibrillation, Escalating higher-energy defibrillation
- Where
- Canada
- Volunteers
- 221 people
- Sponsor
- Ottawa Hospital Research Institute
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
Ventricular Fibrillation, Cardiac Arrest
SmartCPR Trial: An Analysis of a Waveform-Based Automated External Defibrillation (AED) Algorithm on Survival From Out-of-Hospital Ventricular Fibrillation
This study is designed to examine the impact of an available technology within an automated external defibrillator (AEDs) to improve survival following out-of-hospital cardiac arrest for patients presenting in ventricular…
- Trial name
- SmartCPR (NCT00535106)
- Testing
- Automated external defibrillator (Philips FR2+ AED), SmartCPR, Delayed defibrillation
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 900 people
- Sponsor
- New York City Fire Department
Atrial Fibrillation
QOL Improvement After Cardioversion of Persistent AF (QOL-CAFRCT)
Atrial fibrillation (AF) is a type of irregular heart rhythm due to electrical signal disturbances of the heart. It is a very common arrhythmia and the risk of developing AF increases with age and with other risk factors such as…
- Trial name
- QOL-CAFRCT (NCT05136131)
- Testing
- Electrical cardioversion
- Where
- 2 sites in Canada
- Volunteers
- 100 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Cardiac Surgical Procedures
Lead Extract Study
The recent expansion of indications for implantable cardioverter defibrillators (ICDs) has changed the population of patients being implanted.
- Trial name
- EXTRACT (NCT01169441)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- St. Paul Heart Clinic
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
Cardioversion, Atrial Fibrillation
MAX - SHOCK Clinical Trial
Can Electrical Cardioversion (ECV) for AF be improved. It is the preferred method to restore sinus rhythm in patients with AF in whom a rhythm-control strategy is pursued.
- Trial name
- MAX-SHOCK (NCT06556667)
- Testing
- biphasic defibrillator with maximum energy of 200J (® Zoll), biphasic defibrillator with maximum energy of 360J (® Physio-Control)
- Where
- Canada
- Volunteers
- 376 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Persistent Atrial Fibrillation
Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation
Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.
- Trial name
- CAPAPAF-65 (NCT02528604)
- Testing
- Catheter ablation, Pacemaker and AV node ablation, DC Cardioversion
- Where
- 2 sites in United Kingdom
- Volunteers
- 75 people
- Sponsor
- East Sussex Healthcare NHS Trust
Atrial Fibrillation
Timing of Direct Current Cardioversion (DCC) in Patients Undergoing Ablation of Persistent/Permanent Atrial Fibrillation
The purpose of this study is to compare which strategy is superior in patients with persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current cardioversion (DCC) prior to empirical pulmonary vein isolation…
- Trial name
- NCT02429648
- Testing
- DCC first then PVI, PVI then DCC after
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- The Cleveland Clinic
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
Atrial Fibrillation
QT Variability Pre and Post Cardioversion
The purpose of this study is to learn whether the chemicals in the blood and urine are different when the heart is atrial fibrillation compared to normal sinus rhythm.
- Trial name
- DCCV (NCT00885391)
- Where
- United States
- Volunteers
- 219 people
- Sponsor
- Vanderbilt University
Atrial Fibrillation (AF), Heart Failure - NYHA II - IV
Cardiovascular Performance and Exercise Response in Patients With Persistent or Permanent Atrial Fibrillation and Heart Failure Pre and Post Cardioversion or Pace and Ablate
Heart Failure (HF) and Atrial Fibrillation (AF) are two conditions that commonly occur together. Clinical guidelines consider a resting heart rate of 100-110 beats per minute (bpm) acceptable for patients with HF and AF while 72…
- Conditions
- Atrial Fibrillation (AF), Heart Failure - NYHA II - IV, Pacemaker, Cardioversion
- Trial name
- CPEX-CPA (NCT07205679)
- Volunteers
- 40 people
- Sponsor
- Habib Khan
Atrial Fibrillation, Paroxysmal
Clinical Efficacy of Potassium Canrenoate in Sinus Rhythm Restoration Among Patients With Atrial Fibrillation.
The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of potassium canrenoate - canrenone in rapid conversion of atrial fibrillation to sinus rhythm.
- Trial name
- CANREN-AF (NCT03536806)
- Testing
- Saline 0.9%, Canrenone
- Volunteers
- 80 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
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