Clinical trials: Heart Rhythm Disorders
Atrial Fibrillation
Spanish Registry of Cryoballoon Ablation
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy…
- Trial name
- RECABA (NCT02785991)
- Testing
- Balloon cryoablation
- Where
- 28 sites in Spain
- Volunteers
- 1,742 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Tachycardia, Ventricular
S-ICD® System IDE Clinical Study
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
- Trial name
- NCT01064076
- Testing
- S-ICD System
- Where
- 33 sites in United States, Netherlands and 2 more
- Volunteers
- 330 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of…
- Trial name
- Omny-IRE (NCT05971693)
- Testing
- OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
- Where
- 13 sites in Belgium, Canada and 6 more
- Volunteers
- 188 people
- Sponsor
- Biosense Webster, Inc.
Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
The recent study is planned to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart…
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy
- Trial name
- ERASE (NCT04600921)
- Testing
- Ertugliflozin 5 mg
- Where
- 8 sites in Austria
- Volunteers
- 55 people
- Sponsor
- Medical University of Graz
Atrial Fibrillation
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
This study will evaluate the use of a robotic device that is remotely controlled to maneuver a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation procedures.
- Trial name
- VERSATILE (NCT01656772)
- Testing
- Vdrive Lasso navigation, Manual Lasso navigation
- Where
- 5 sites in United States, Belgium and 1 more
- Volunteers
- 120 people
- Sponsor
- Stereotaxis
Atrial Fibrillation
A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)
To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial…
- Trial name
- NCT02069119
- Testing
- OPC-108459
- Where
- Japan
- Volunteers
- 48 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Arrhythmias, Cardiac
Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients
Hemodialysis patients have a rate of fatal arrhythmias that is 40 times greater than the general population, but the causes and types of fatal arrhythmias they experience is unclear.
- Trial name
- CARE-ESRD (NCT00932659)
- Testing
- continuous cardiac monitoring device (REVEAL, Medtronic)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Duke University
Atrial Fibrillation
Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery
In this study, the investigators aim to determine whether injecting botulinum toxin into epicardial fat pads is efficacious and safe for decreasing postoperative atrial fibrillation (POAF) after cardiac surgery.
- Trial name
- NCT02498769
- Testing
- Botulinum Toxin Type A
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Joseph Mathew, M.D.
Heart Arrest, Birth Asphyxia
SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Research question In newborn infants requiring CPR, does CC superimposed by sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation? Overall objective: CC superimposed by…
- Conditions
- Heart Arrest, Birth Asphyxia, Bradycardia
- Trial name
- SURV1VE (NCT02858583)
- Testing
- CC+SI, 3:1 C:V
- Where
- 4 sites in Austria, Canada
- Volunteers
- 27 people
- Sponsor
- University of Alberta
Persistent Atrial Fibrillation
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation…
- Trial name
- ADVANTAGE AF (NCT05443594)
- Testing
- Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 669 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Continued Access Protocol
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review.
- Trial name
- CAP-AF (NCT00889681)
- Testing
- Arctic Front Cardiac Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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, Patient Engagement
Data-driven SDM to Reduce Symptom Burden in AF
This study is a single-group feasibility study evaluating decision aid visualizations which display common post-ablation symptom patterns as a tool for shared decision-making.
- Trial name
- NCT04993807
- Testing
- Shared decision-making tool
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Columbia University
Persistent Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.
- Trial name
- Diamond-AFII (NCT03643224)
- Testing
- Radiofrequency Ablation
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 376 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Familial Atrial Fibrillation
Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties
Atrial fibrillation (AF) is a highly prevalent, morbid condition. Anticoagulation to prevent thromboembolic strokes is a foremost priority in AF but adherence is challenging for patients and lapses in anticoagulation are common.
- Conditions
- Atrial Fibrillation, Familial Atrial Fibrillation, Arrhythmia, Cardiac, Heart Diseases
- Trial name
- AFibLITT_R (NCT04076020)
- Testing
- Relational agent/AliveCor Kardia - Intervention, Usual Care
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- University of Pittsburgh
Ventricular Arrythmia
Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias
This study will examine the safety and efficacy of intramural needle ablation (INA) in the treatment of intramural ventricular arrhythmias in patients for whom standard RF ablation has been unsuccessful.
- Trial name
- NCT03204981
- Testing
- Intramural Needle Ablation, Ablation
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Vivek Reddy
Atrial Fibrillation
This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain
This is an observational, multicenter and cross-sectional study in Non-valvular atrial fibrillation (NVAF) elderly patients currently on Non-vitamin K antagonist oral anticoagulant (NOAC) treatment for their stroke prevention.
- Trial name
- NCT03993119
- Testing
- Non-vitamin K antagonist oral anticoagulant
- Where
- 45 sites in Spain
- Volunteers
- 500 people
- Sponsor
- Boehringer Ingelheim
Systolic Heart Failure, Atrial Fibrillation (Permanent)
Junctional AV Ablation in CRT-D: JAVA-CRT
Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for patients with heart failure with reduced ejection fraction and specific indication.
- Trial name
- NCT02946853
- Testing
- Atrioventricular junctional (AVJ) ablation, Cardiac resynchronization therapy - defibrillator
- Where
- 21 sites in United States
- Volunteers
- 26 people
- Sponsor
- University of Rochester
Atrial Fibrillation
Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including a large sheath when the Cryo Balloon is used for pulmonary vein isolation.
- Trial name
- Figure 8 (NCT03040661)
- Testing
- Ablation for atrial fibrillation.
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Inova Health Care Services
Tachyarrhythmia
Full Automaticity and Remote Follow-up
With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years.
- Trial name
- NCT01526629
- Where
- France
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure