Clinical trials: Heart Rhythm Disorders
Atrial Fibrillation
Electrocardiogram Clinical Validation Study
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device.
- Trial name
- NCT03492554
- Testing
- 1-Lead ECG, 12-Lead ECG
- Where
- 5 sites in United States
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Atrial Fibrillation, Ventricular Tachycardia
An Assessment of Dual Site Left Ventricular Endocardial Pacing
We are investigating ways to help patients with heart failure, which is caused by damaged hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of energy and swelling.
- Conditions
- Atrial Fibrillation, Ventricular Tachycardia, Heart Failure
- Trial name
- DOUBLE-CRT (NCT02211456)
- Testing
- Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Oxford University Hospitals NHS Trust
Bradycardia
INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
- Trial name
- NCT04346537
- Testing
- INGEVITY+™ Pace/Sense Lead
- Where
- 13 sites in United States
- Volunteers
- 109 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
Paroxysmal Atrial Fibrillation (PAF)
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
- Trial name
- ZERO-AF (NCT01687166)
- Testing
- Blazer Open-Irrigated Ablation Catheter (Boston Scientific), FDA Approved Open-Irrigated Ablation Catheter
- Where
- 38 sites in United States, Australia and 7 more
- Volunteers
- 398 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
Primary Objective: Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization…
- Trial name
- PALLAS (NCT01151137)
- Testing
- Dronedarone
- Where
- 37 sites in United States, Argentina and 35 more
- Volunteers
- 3,236 people
- Sponsor
- Sanofi
Bradycardia
Micra Transcatheter Pacing System Continued Access Study Protocol
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
- Trial name
- NCT02488681
- Testing
- Micra Pacemaker Implant
- Where
- 29 sites in United States
- Volunteers
- 285 people
- Sponsor
- Medtronic
Paroxysmal Atrial Fibrillation
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
- Trial name
- NCT00971204
- Testing
- CardioFocus HeartLight Endoscopic Ablation System
- Where
- 10 sites in United States
- Volunteers
- 100 people
- Sponsor
- CardioFocus
Ventricular Fibrillation, Ventricular Tachycardia
Shockless Implant Evaluation
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks.
- Trial name
- SIMPLE (NCT00800384)
- Testing
- Implantable defibrillator
- Where
- 85 sites in Australia, Austria and 16 more
- Volunteers
- 2,500 people
- Sponsor
- Boston Scientific Corporation
Tachycardia, Ventricular Arrythmia
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
- Trial name
- NCT07091916
- Testing
- Defibrillation using the Extravascular ICD
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation
The investigators' central hypothesis is that in patients with atrial fibrillation, anticoagulation with Apixaban reduces the rate of decline in cognitive function, when compared to Warfarin.
- Trial name
- ARISTA (NCT03839355)
- Testing
- Apixaban, Warfarin
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Mayo Clinic
Ventricular Tachycardia
Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia
The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter).
- Trial name
- NCT01791543
- Testing
- Intramural Needle Ablation Catheter
- Where
- 2 sites in United States
- Volunteers
- 115 people
- Sponsor
- William Stevenson
Bradycardia, Sinus Node Dysfunction
Physiologic Pacing Registry
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements…
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT03719040
- Testing
- Physiologic pacing device implant
- Where
- 50 sites in United States, Australia and 14 more
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
STOP Persistent AF
To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation (AF).
- Trial name
- NCT03012841
- Testing
- Arctic Front Advance Cardiac CryoAblation Catheter
- Where
- 25 sites in United States, Canada and 1 more
- Volunteers
- 186 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
SDM for Stroke Prevention in Atrial Fibrillation
The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.
- Trial name
- SDM4Afib (NCT02905032)
- Testing
- Decision Aid
- Where
- 5 sites in United States
- Volunteers
- 1,186 people
- Sponsor
- Mayo Clinic
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
Bradycardia
Endothelial Function and Cardiac Output in RV Pacing
Pacing from the right ventricle (as is current practice in patients implanted with permanent pacemakers for bradycardia), has been associated with worse outcomes particularly in heart failure patients.
- Trial name
- NCT00508196
- Testing
- RVP-min, RVP-max
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- University of Dundee
Atrial Fibrillation
Corticosteroid Pulse After Ablation
Radiofrequency ablation is an effective treatment for atrial fibrillation. However, about 20% of the time the atrial fibrillation recurs.
- Trial name
- SAAB (NCT00807586)
- Testing
- Solumedrol
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- Minneapolis Heart Institute Foundation
Cardiac Arrhythmia
Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
This trial assesses the wear performance of the Zio monitor, a long-term continuous ambulatory patch ECG monitor, in a representative population by evaluating (1) the wear duration (up to 30 days) of the device, (2) the…
- Trial name
- NCT07205367
- Testing
- Zio Monitor
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- iRhythm Technologies, Inc.
Post-operative Pain
A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery
The goal of the proposed study is to investigate the relationship between two standard treatments, lidocaine or a mixture of lidocaine and bupivacaine, and 1) postoperative pain, and; 2) narcotic use following pacemaker or…
- Trial name
- NCT01300377
- Testing
- Bupivacaine / Lidocaine, Lidocaine
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Baylor Research Institute