Clinical trials: Heart Rhythm Disorders
Ventricular Tachycardia
Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator
The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is…
- Trial name
- CALYPSO (NCT01576042)
- Testing
- amiodarone, sotalol, Biosense Webster's NAVI-STAR Thermo-Cool
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Duke University
Atrial Fibrillation
Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment
To describe the direct costs related to warfarin/apixaban treatment
- Trial name
- NCT04435769
- Where
- Czechia
- Volunteers
- 109 people
- Sponsor
- Pfizer
Physical Activity, Pacemaker
Physical Activity and Pacemaker Study
The benefits of regular physical activity are well-established. Furthermore, the investigators have previously shown that in a population of patients with implanted pacemakers, those who exercise more than 2 hours daily have…
- Conditions
- Physical Activity, Pacemaker, Cardiovascular Diseases, Arrythmia
- Trial name
- NCT03052829
- Testing
- Physical activity counseling, Usual care
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Medical College of Wisconsin
Tachycardia, Ventricular Arrythmia
Extravascular ICD Pivotal Study
Pivotal Summary: The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
- Trial name
- EV ICD (NCT04060680)
- Testing
- Defibrillation using the Extravascular ICD
- Where
- 56 sites in United States, Australia and 15 more
- Volunteers
- 393 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication
The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and…
- Trial name
- TendrilMRI™ (NCT01528150)
- Volunteers
- 466 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Ventricular
Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System.
- Trial name
- EFFORTLESS (NCT01085435)
- Testing
- S-ICD System
- Where
- 44 sites in Czechia, Denmark and 8 more
- Volunteers
- 994 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
- Trial name
- REDO-FIRM (NCT02799043)
- Testing
- Standard PVI, FIRM-Guided Procedure and PVI
- Where
- 24 sites in United States, Belgium and 2 more
- Volunteers
- 269 people
- Sponsor
- Abbott Medical Devices
Bradyarrhythmia
Safety and Efficacy Study of IPG Patient With Home Monitoring
The number of patients with implantable pulse generator (IPG) has steadily increased in Japan causing increment in number of in office follow-ups and greater burden on many hospitals.
- Trial name
- NCT01523704
- Testing
- BIOTRONIK Home Monitoring System, BIOTRONIK Home Monitoring System with In-office Follow-up
- Where
- Japan
- Volunteers
- 1,327 people
- Sponsor
- Biotronik Japan, Inc.
Atrial Fibrillation
Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes
The primary purpose of this study is to assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.
- Trial name
- NCT01206452
- Testing
- Prednisone, Ablation Procedure
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Dhanunjaya Lakkireddy, MD, FACC
Atrial Fibrillation
Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)
The researchers are observing subject and clinician interaction in order to develop future education materials that will help patients and clinicians discuss atrial fibrillation and options to treat it.
- Trial name
- (DA4AFib) (NCT03744936)
- Testing
- Feedback
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Mayo Clinic
Atrial Fibrillation
RF Power, LSI and Oesophageal Temperature Alerts During AF Ablation (PiLOT-AF Study)
Atrial fibrillation (AF) is a very common abnormal heart rhythm, triggered by rapid electrical activity originating from the pulmonary veins (PVs) that drain blood from the lungs back to the left atrium (LA).
- Trial name
- PiLOT-AF (NCT02619396)
- Testing
- Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall, Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall, Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
- Where
- United Kingdom
- Volunteers
- 80 people
- Sponsor
- Oxford University Hospitals NHS Trust
Sinus Bradycardia, Sinus Node Disease
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
- Conditions
- Sinus Bradycardia, Sinus Node Disease, Atrio-ventricular Block
- Trial name
- IES-ACap (NCT00832260)
- Volunteers
- 70 people
- Sponsor
- Abbott Medical Devices
Arrhythmia
Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States
The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™ insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure performed in the in-office setting is as safe as…
- Trial name
- RIO 2 (NCT02395536)
- Testing
- office setting, hosptial setting
- Where
- 27 sites in United States
- Volunteers
- 525 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Medtronic Reveal XT Study
While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years, virtually all of the historical series reported only the recurrence of symptomatic AF and have used only intermittent electrocardiogram…
- Trial name
- NCT01526343
- Testing
- Reveal XT implantation
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- Washington University School of Medicine
Severe Respiratory Syncytial Virus Infection
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that…
- Trial name
- NCT01075178
- Where
- 37 sites in Austria, Belgium and 8 more
- Volunteers
- 2,036 people
- Sponsor
- Abbott
Atrial Fibrillation
Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial
The proposed study is designed to evaluate the effect of an intravenous infusion of magnesium sulfate in facilitating successful cardioversion of atrial fibrillation and in decreasing the energy threshold (in J) required for…
- Trial name
- MICA (NCT01597557)
- Testing
- Magnesium Sulfate
- Where
- United States
- Volunteers
- 261 people
- Sponsor
- State University of New York at Buffalo
Atrioventricular Block, Heart Diseases
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- BLOCK HF (NCT00267098)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 54 sites in United States, Canada
- Volunteers
- 918 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arterial Thromboembolic Events, Atrial Fibrillation
Effectiveness of Bridging Anticoagulation for Surgery (The BRIDGE Study)
Blood thinners, such as warfarin, prevent blood clots from forming, thereby reducing the risk of a stroke or heart attack. When people undergo surgery or certain procedures, they must stop using warfarin to prevent too much…
- Trial name
- NCT00786474
- Testing
- Dalteparin
- Where
- United States
- Volunteers
- 1,884 people, healthy volunteers welcome
- Sponsor
- Duke University
Atrial Fibrillation
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study.
- Trial name
- SELECT-AF (NCT00926783)
- Testing
- CFAE ablation
- Where
- 7 sites in United States, Australia and 1 more
- Volunteers
- 86 people
- Sponsor
- Biosense Webster, Inc.
Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI…
- Trial name
- NCT01576016
- Testing
- Accent MRI system (lead safety), Accent MRI system (with MRI scan)
- Where
- 70 sites in United States, Australia and 3 more
- Volunteers
- 950 people
- Sponsor
- Abbott Medical Devices