Clinical trials: Cardiac Rhythm Disorder
Paroxysmal Atrial Fibrillation
Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Single shot devices are increasingly used for PVI.
- Trial name
- COMPARE-CRYO (NCT04704986)
- Testing
- PVI using the Arctic Front Cryoballoon (Medtronic), PVI using the PolarX Cryoballoon (Boston Scientific)
- Where
- 2 sites in Switzerland
- Volunteers
- 202 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Atrial Fibrillation
First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)
The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not…
- Trial name
- RAAFT (NCT00392054)
- Testing
- Pulmonary Vein Isolation performed by Catheter Ablation, Conventional Antiarrhythmic Drug Therapy
- Where
- 16 sites in United States, Canada and 3 more
- Volunteers
- 127 people
- Sponsor
- Population Health Research Institute
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 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
Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation
To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection with a multipolar catheter (Pentaray) and the " SCI 30-40 " setting of CARTO CFAE algorithm.
- Trial name
- SUBSTRATE-HD (NCT02093949)
- Testing
- Routine substrate ablation without pulmonary vein Isolation, Routine conventional ablation with pulmonary vein Isolation
- Where
- 3 sites in France
- Volunteers
- 152 people
- Sponsor
- Hospital St. Joseph, Marseille, France
Atrial Fibrillation, Thoracic Surgery
Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study
The purpose of this pilot study is to determine the feasibility of comparing colchicine to placebo for the prevention of new onset atrial fibrillation in patients undergoing general thoracic surgery and establish the foundation…
- Trial name
- COP-AF Pilot (NCT01985425)
- Testing
- Colchicine 0.6 mg
- Where
- 2 sites in Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Population Health Research Institute
Atrial Fibrillation, Arrythmia
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- ABC (NCT05704426)
- Testing
- Impulse Dynamics Optimizer Device
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Hackensack Meridian Health
Atrial Fibrillation, Persistent
FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology
This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).
- Trial name
- FLOW-AF (NCT04473963)
- Testing
- Electrographic Flow™ guided ablation
- Where
- 4 sites in Czechia, Germany and 1 more
- Volunteers
- 85 people
- Sponsor
- Cortex
Diabetes, Hypertension
Scripps Wired for Health Monitoring Study
People with chronic diseases such as diabetes, hypertension (high blood pressure) and cardiac (heart) arrhythmias tend to go to the doctor more often and have more tests done than those without those diseases.
- Conditions
- Diabetes, Hypertension, Cardiac Arrhythmia
- Trial name
- NCT01975428
- Testing
- DM Pgm + device, Control
- Where
- United States
- Volunteers
- 182 people
- Sponsor
- Scripps Translational Science Institute
Sinus Node Dysfunction
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
- Trial name
- IMPROVE Brady (NCT01643707)
- Testing
- Evidence based guidelines and tools
- Where
- 21 sites in Argentina, Bangladesh and 5 more
- Volunteers
- 1,342 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Cardioversion
Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation
Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo transesophageal echocardiography or they will receive warfarin for 3 weeks with an international normalized ratio (INR) value between…
- Conditions
- Atrial Fibrillation, Cardioversion, Cerebrovascular Stroke
- Trial name
- AFTER-CV (NCT01924065)
- Testing
- Cardioversion, Oral Anticoagulant
- Where
- Turkey (Türkiye)
- Volunteers
- 112 people
- Sponsor
- Suleyman Demirel University
Atrial Fibrillation, Stroke
Patient Convenience Study (RE-SONANCE)
The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its…
- Trial name
- NCT02684981
- Where
- 12 sites in Austria, Bulgaria and 10 more
- Volunteers
- 9,472 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Atrial Fibrillation Algorithms Clinical Validation Study
The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.
- Trial name
- NCT04699812
- Testing
- ELECTROCARDIOGRAM (ECG) PATCH WEAR
- Where
- 4 sites in United States
- Volunteers
- 573 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Paroxysmal Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.
- Trial name
- DIAMOND-AF (NCT03334630)
- Testing
- DiamondTemp Ablation catheter, TactiCath Quartz Ablation catheter
- Where
- 23 sites in United States, Canada and 3 more
- Volunteers
- 482 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Cardiovascular Disease
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)
The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation…
- Trial name
- ACTIVE I (NCT00249795)
- Testing
- Irbesartan
- Where
- 30 sites in United States, Argentina and 28 more
- Volunteers
- 9,016 people
- Sponsor
- Sanofi
Type 1 Diabetes Mellitus, Hypoglycemia
24/7 Closed-loop in Older Subjects With Type 1 Diabetes
The main objective of this open-label, multi-centre, randomised, crossover design study is to determine whether automated day and night closed-loop insulin delivery for 16 weeks under free living conditions is safer and more…
- Conditions
- Type 1 Diabetes Mellitus, Hypoglycemia, Arrythmia
- Trial name
- DAN06 (NCT04025762)
- Testing
- Hybrid closed-loop system (CamAPS FX), Sensor augmented pump therapy
- Where
- 2 sites in United Kingdom
- Volunteers
- 38 people
- Sponsor
- University of Cambridge
Atrial Fibrillation, Device Related Thrombus
Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers.
- Conditions
- Atrial Fibrillation, Device Related Thrombus, Left Atrial Appendage Thrombosis, Watchman LAA Closure Device
- Trial name
- DEA-LAA (NCT03539055)
- Testing
- Dabigatran Etexilate Oral Capsule
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Vanderbilt University Medical Center
Heart Failure, Right Bundle-Branch Block
Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)
Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis.
- Trial name
- PACE-RBBB (NCT01169493)
- Testing
- VVI-40, RV DDD-40, BiV DDD-40
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Duke University
Arrhythmogenic Right Ventricular Cardiomyopathy
Pilot Randomized Trial With Flecainide in ARVC Patients
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited arrhythmia disorder with high risk of ventricular tachycardia or fibrillation, and implantable cardioverter defibrillator remains as therapy of choice.
- Trial name
- NCT03685149
- Testing
- Flecainide Pill
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- University of Rochester
Paroxysmal Atrial Fibrillation
A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
PEFCAT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the FARAPULSE Endocardial Ablation System for the treatment of paroxysmal atrial fibrillation.
- Trial name
- NCT03714178
- Testing
- FARAPULSE Endocardial Ablation System
- Where
- 2 sites in Czechia, France
- Volunteers
- 71 people
- Sponsor
- Boston Scientific Corporation