Clinical trials: Electric Countershock
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
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
- 97 sites in United States, Austria and 7 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic
Tachycardia
Safety and Performance Study of the Reliance 4-Front Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Active Fixation Defibrillation Leads.
- Trial name
- NCT01772576
- Testing
- Reliance 4-Front lead implantation
- Where
- 15 sites in Austria, China and 9 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients…
- Trial name
- RESTORE-1 (NCT05039359)
- Testing
- FlecIH-103
- Where
- 40 sites in United States, Czechia and 4 more
- Volunteers
- 54 people
- Sponsor
- InCarda Therapeutics, Inc.
DFT Testing
50/50% Tilt and Tuned Defibrillation Waveform
Study Description The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High Voltage Lead Integrity Check (HVLIC) impedance.
- Trial name
- NCT01325922
- Testing
- DFT Testing with a 50/50% tilt
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure
Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure
The purpose of this study is to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optimal pharmacologic therapy and 1)…
- Trial name
- NCT00180258
- Testing
- Cardiac Resynchronization Therapy with & without defibrillator
- Where
- United States
- Volunteers
- 2,200 people
- Sponsor
- Boston Scientific Corporation
Ventricular Fibrillation, Ventricular Tachycardia
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
The main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock…
- Trial name
- iD-System (NCT04011631)
- Testing
- Internal defibrillation during cardiac surgery, using the iD-system
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- SMART Clinical Products BV
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
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.
Ventricular Tachycardia, Ventricular Fibrillation
Leader - Evaluation of Endotak Reliance
The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.
- Trial name
- NCT00180349
- Testing
- Endotak Reliance
- Where
- 25 sites in France
- Volunteers
- 904 people
- Sponsor
- Boston Scientific Corporation
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
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
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
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
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
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
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
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.
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
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