Clinical trials: Cardioversion
Atrial Fibrillation, Recurrence
Comparison of Effectiveness of Ranolazine Plus Metoprolol Combination vs. FlecainidE pluS Metoprolol Combination in ATrial Fibrillation Recurrences FOllowing PhaRmacological or Electrical CardioverSion of AtRial Fibrillation
Atrial fibrillation (AF) is the most common arrhythmia in clinical practice with a prevalence reaching 5% in patients older than 65 years and an incidence that increases progressively with age.1 According to the most recent…
- Trial name
- PRESERVE-SR (NCT03162120)
- Testing
- Ranolazine plus Metoprolol Combination, FlecainidE pluS Metoprolol Combination
- Sponsor
- Elpen Pharmaceutical Co. Inc.
Heart Failure, Systolic Bundle Branch Block, Left
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator…
- Trial name
- ACHIEVED LBBAP (NCT07526896)
- Testing
- LBBAP Therapy, LOT-CRT, ICD
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin.
- Trial name
- ENSURE-AF (NCT02072434)
- Testing
- Edoxaban, Warfarin, Enoxaparin
- Where
- 228 sites in United States, Austria and 17 more
- Volunteers
- 2,199 people
- Sponsor
- Daiichi Sankyo
Atrial Fibrillation
A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
This Phase 2 study is a two-stage, serial cohort dose escalation and expansion study of a single 30-minute (IV) infusion of HBI-3000 for the conversion of patients with recent-onset atrial fibrillation (AF).
- Trial name
- NCT04680026
- Testing
- HBI-3000
- Where
- 14 sites in United States, Bosnia and Herzegovina and 3 more
- Volunteers
- 150 people
- Sponsor
- HUYABIO International, LLC.
Atrial Fibrillation
International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)
This study will create a prospective registry of consecutive patients with Atrial Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of in-hospital treatment, with a focus on the…
- Trial name
- RHYTHM-AF (NCT01119716)
- Volunteers
- 4,658 people
- Sponsor
- Merck Sharp & Dohme LLC
Ventricular Arrythmia
Non-vascular ICD Electrode Configuration Feasibility Study
This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.
- Trial name
- NCT04809701
- Testing
- Temporary implantation of defibrillation coils and pulse generator, Defibrillation following induction of VA (Configuration A first), Defibrillation following induction of VA (Configuration B first)
- Where
- 3 sites in Chile, Czechia and 1 more
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Ventricular Arrythmia, Ventricular Fibrillation
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study
The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of…
- Conditions
- Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
- Trial name
- ASCEND EV (NCT06592001)
- Testing
- Atala™ lead
- Where
- 3 sites in Croatia, New Zealand and 1 more
- Volunteers
- 19 people
- Sponsor
- AtaCor Medical, Inc.
Persistent Atrial Fibrillation
Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion
Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low, intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful electrical cardioversion in patients with…
- Trial name
- RAFFAELLO (NCT01534962)
- Testing
- Ranolazine
- Where
- 4 sites in Germany, Italy and 2 more
- Volunteers
- 241 people
- Sponsor
- Menarini Group
VF, VT
Defibrio AED Study
The purpose of this research is to test an investigational device called the Defibrio AED (automated external defibrillator). The researchers are conducting the study to determine if the Defibrio AED is safe to use and is able to…
- Trial name
- NCT07880873
- Testing
- treatment with Defibrio AED
- Volunteers
- 25 people
- Sponsor
- Defibrio, LLC
Cardiac Resynchronization Therapy
Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation…
- Trial name
- NAVIGATE X4 (NCT02071173)
- Testing
- ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead
- Where
- 96 sites in United States
- Volunteers
- 2,244 people
- Sponsor
- Boston Scientific Corporation
Tachyarrhythmia
Lead Evaluation for Defibrillation and Reliability Post Approval Study
Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release.
- Trial name
- LEADR PAS (NCT07005232)
- Testing
- defibrillation lead
- Where
- 73 sites in United States, Austria and 5 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic
Fibrillation, Atrial
Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm
The purpose of this study is to test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm…
- Trial name
- NCT00911300
- Testing
- fondaparinux, unfractionated heparin, Vitamin-K-Antagonist
- Where
- 34 sites in France, Germany
- Volunteers
- 349 people
- Sponsor
- GlaxoSmithKline
Atrial Fibrillation
A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
An assessment of the use of cold therapy to terminate atrial fibrillation.
- Trial name
- NAPC (NCT05324540)
- Testing
- Cool therapy
- Volunteers
- 30 people
- Sponsor
- MediCool Technologies
Ventricular Arrhythmia, Ventricular Tachycardia
Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
The SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant, and…
- Conditions
- Ventricular Arrhythmia, Ventricular Tachycardia, Ventricular Fibrillation
- Trial name
- SECURE EV (NCT05352776)
- Testing
- AtaCor EV-ICD Lead
- Where
- Paraguay
- Volunteers
- 18 people
- Sponsor
- AtaCor Medical, Inc.
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
Healthy
Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants
The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in patients with right-sided implants.
- Trial name
- Tilt & Tune (NCT00873691)
- Testing
- ICD
- Where
- United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of one or more doses of AP30663 for cardioversion in adult participants with AF.
- Trial name
- NCT04571385
- Testing
- AP30663
- Where
- 15 sites in Denmark, Hungary
- Volunteers
- 66 people
- Sponsor
- Acesion Pharma
Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.
- Trial name
- LSS of 4-SITE (NCT01596595)
- Where
- 111 sites in United States, Australia and 1 more
- Volunteers
- 1,820 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Atrial Flutter
Double Blind Placebo COntrolled Dose Ranging studY of the eFficacy and safEty of SSR149744c 300 or 600 mg for the Conversion of Atrial Fibrillation / fluttEr
Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.
- Trial name
- CORYFEE (NCT00232310)
- Testing
- CELIVARONE (SSR149744C)
- Where
- 9 sites in United States, Canada and 7 more
- Volunteers
- 150 people
- Sponsor
- Sanofi
Ventricular Arrythmia, Ventricular Fibrillation
Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
The ALARION EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls.
- Conditions
- Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
- Trial name
- ALARION EV (NCT07324031)
- Testing
- Atala™ lead and EV-ICD Pulse Generator
- Where
- 35 sites in United States, Netherlands
- Volunteers
- 280 people
- Sponsor
- AtaCor Medical, Inc.