Clinical trials: Cardiac Rhythm Disorder
Cardioversion, Atrial Fibrillation
Heart Watch Study: a Pragmatic Randomized Controlled Trial
This will be a prospective multi-center, randomized, controlled trial of 150 patients conducted to assess the impact of individual use of the Apple Watch compared to the Withings Move on patient-reported and clinical outcomes at…
- Trial name
- NCT04468321
- Testing
- Apple Watch, Withings Move
- Where
- 3 sites in United States
- Volunteers
- 105 people
- Sponsor
- Yale University
Atrial Fibrillation, Heart Failure
Catheter Ablation Versus Medical Treatment of AF in Heart Failure
Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity and mortality associated with the other.
- Trial name
- CAMTAF (NCT01411371)
- Testing
- Catheter ablation of persistent atrial fibrillation, Medical treatment alone
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Barts & The London NHS Trust
Atrial Fibrillation
Anticoagulants Comparative Benefit-risk Ratio in Real Life
The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.
- Trial name
- NCT02785354
- Where
- France
- Volunteers
- 103,101 people
- Sponsor
- Boehringer Ingelheim
Atrioventricular Conduction Block
Micra Atrial TRacking Using A Ventricular AccELerometer 2
The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal…
- Trial name
- MARVEL2 (NCT03752151)
- Testing
- MARVEL 2 Algorithm Monitor Mode then Adaptive Mode
- Where
- 12 sites in United States, Austria and 6 more
- Volunteers
- 77 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation
REVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to assess the safety and effectiveness of the Circular and Crescent Mapping and Ablation catheters and the workflow of the Multi-Electrode Irrigated Pulmonary Vein Isolation System when used for the…
- Trial name
- REVOLUTION (NCT01353586)
- Testing
- nMARQ™ System
- Where
- 8 sites in Belgium, Czechia and 4 more
- Volunteers
- 186 people
- Sponsor
- Biosense Webster, Inc.
Anticoagulant Therapy
In Vitro Diagnostic Test for DOAC in Urine
This trial is conducted to assess the performance and handling of the in vitro diagnostic (IVD) device for oral direct factor Xa and thrombin inhibitors from urine samples of patients on treatment with direct oral anticoagulants…
- Trial name
- PADOASU (NCT03182829)
- Testing
- DOAC Dipstick
- Where
- 18 sites in Germany
- Volunteers
- 880 people
- Sponsor
- Doasense GmbH
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
HD Mapping of Atrial Fibrillation in Asia Pacific
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop…
- Trial name
- NCT04022954
- Testing
- Catheter ablation
- Where
- 15 sites in China, Hong Kong and 3 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Paroxysmal Atrial Fibrillation
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon…
- Trial name
- ADVENT (NCT04612244)
- Testing
- FARAPULSE Pulsed Field Ablation System, RadioFrequency and Cryoballoon Ablation
- Where
- 34 sites in United States
- Volunteers
- 706 people
- Sponsor
- Boston Scientific Corporation
Heart Diseases, Arrhythmia
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- Afib IDE (NCT00116428)
- Testing
- NAVISTAR® THERMOCOOL® Catheter, Antiarrhythmic drug
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 167 people
- Sponsor
- Biosense Webster, Inc.
Atrial Flutter
Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter
The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1 atrial flutter.
- Trial name
- BLOCk-CTI (NCT01253200)
- Testing
- Blazer® Open-Irrigated Ablation Catheter, Control Catheter
- Where
- 26 sites in United States
- Volunteers
- 302 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation
The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation.
- Trial name
- NCT00408200
- Testing
- propafenone; flecainide; sotalol; dofetilide, Radiofrequency catheter ablation
- Where
- 2 sites in United States
- Volunteers
- 110 people
- Sponsor
- University of Pennsylvania
Atrial Fibrillation Chronic, Persistent Atrial Fibrillation
Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with…
- Trial name
- PIVoTAL (NCT03057548)
- Testing
- Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins, Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW
- Where
- 2 sites in United States, Japan
- Volunteers
- 110 people
- Sponsor
- Arash Aryana, MD
Atrial Fibrillation
Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)
This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.
- Trial name
- PRECEPT (NCT02817776)
- Testing
- THERMOCOOL SMARTTOUCH® SF catheter
- Volunteers
- 381 people
- Sponsor
- Biosense Webster, Inc.
Bradycardia, Sinus Node Dysfunction
LBBAP Data Collection Registry
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT05887323
- Testing
- Implantation of the Tendril 2088 lead in the LBBA
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 221 people
- Sponsor
- Abbott Medical Devices
Ventricular Tachycardia
REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain.
- Trial name
- RESET-VT (NCT01858194)
- Testing
- Renal sympathetic denervation, VT ablation alone
- Where
- 2 sites in United States, Czechia
- Volunteers
- 21 people
- Sponsor
- Vivek Reddy
Atrial Fibrillation, Heart Failure
AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with…
- Trial name
- PACIFIC (NCT00589303)
- Testing
- FDA approved rate and rhythm control drugs, AV Node ablation and device implant
- Where
- 6 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Mayo Clinic
Atrial Fibrillation
PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin
The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and other adverse events.
- Trial name
- NCT01227629
- Testing
- dabigatran with ASA, warfarin, dabigatran without ASA
- Where
- 38 sites in United States, Denmark and 1 more
- Volunteers
- 502 people
- Sponsor
- Boehringer Ingelheim
AV Block, AV Block Complete
Accelerometer Sensing for Micra AV Study
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
- Conditions
- AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
- Trial name
- AccelAV (NCT04245345)
- Testing
- Accelerometer Sensing for Micra AV Study
- Where
- 20 sites in United States, Hong Kong
- Volunteers
- 157 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachycardia, Ischemic
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic…
- Trial name
- ASPIRE (NCT01557842)
- Testing
- Drug Treatment, Catheter Ablation
- Where
- 23 sites in United States
- Volunteers
- 15 people
- Sponsor
- Biosense Webster, Inc.