Clinical trials: Cardiac Arrhythmias
ICD, Tachycardia
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.
- Trial name
- ASIA MRI ICD (NCT02877693)
- Testing
- Thoracic MRI Scan
- Where
- 20 sites in India, Malaysia and 1 more
- Volunteers
- 205 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation
IMPULSE is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
- Trial name
- NCT03700385
- Testing
- IOWA Approach Endocardial Ablation System
- Where
- 2 sites in Czechia, France
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Ventricular Fibrillation, Ventricular Tachycardia
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Low Cardiac Output
- Trial name
- UNTOUCHED (NCT02433379)
- Testing
- EMBLEM S-ICD System
- Where
- 110 sites in United States, Belgium and 11 more
- Volunteers
- 1,173 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation, Ventricular Tachycardia
Advisor HD Grid Observational Study
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 Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called…
- Trial name
- NCT03733392
- Testing
- Advisor HD Grid Mapping Catheter, Sensor Enabled
- Where
- 25 sites in Australia, Austria and 9 more
- Volunteers
- 379 people
- Sponsor
- Abbott Medical Devices
Bradycardia
Accent Cardiac MRI Study
The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system. The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.
- Trial name
- Accent Cardiac (NCT02041702)
- Testing
- Non-Diagnostic Cardiac MRI scan
- Where
- 13 sites in China, Hong Kong and 3 more
- Volunteers
- 283 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
This study is a single-center, prospective, randomized, open-label trial of subjects who develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky Chandler Medical Center (UKCMC).
- Trial name
- RADICAL (NCT05004077)
- Testing
- AMIODARONE
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Kevin W Hatton, MD, PhD
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- COSMOS (NCT05373862)
- Testing
- Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Where
- 4 sites in Belgium, Croatia and 1 more
- Volunteers
- 40 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction
The pilot portion of this study is to determine the feasibility of utilizing AF CARE to provide lifestyle modification support to patients with atrial fibrillation (AF).
- Trial name
- AFCARE (NCT04050982)
- Testing
- AF CARE, Usual Care
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Stanford University
Atrial Fibrillation, Vascular Risk
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)
The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular…
- Trial name
- NCT00249873
- Testing
- clopidogrel (SR25990C)
- Where
- 30 sites in United States, Argentina and 28 more
- Volunteers
- 7,554 people
- Sponsor
- Sanofi
Ventricular Tachycardia, Ventricular Fibrillation
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
- Trial name
- DATAS (NCT00157820)
- Testing
- Single Chamber Implantable Cardioverter Defibrillator, Dual Chamber implantable cardioverter defibrilator
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation
Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory…
- Trial name
- NEwTON AF (NCT04580914)
- Testing
- Treatment with IntellaNav StablePoint Ablation Catheter
- Where
- 47 sites in United States, Austria and 11 more
- Volunteers
- 321 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in…
- Trial name
- SmartfIRE (NCT05752487)
- Testing
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
- Where
- 9 sites in Austria, Belgium and 2 more
- Volunteers
- 149 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
Postoperative Atrial Fibrillation
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF).
- Trial name
- NCT02132767
- Testing
- Amiodarone, DC-cardioversion, Rate Control
- Where
- 23 sites in United States, Canada
- Volunteers
- 523 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Atrial Fibrillation, Hypertension
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a…
- Trial name
- Symplicity AF (NCT02064764)
- Testing
- Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Arctic Front Advance™ Cardiac Cryoablation System
- Where
- 10 sites in United States, Germany
- Volunteers
- 102 people
- Sponsor
- Medtronic Vascular
Persistent Atrial Fibrillation
The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation
The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Pulsed Field Ablation System Plus-PersAF…
- Trial name
- CS1543 (NCT05272852)
- Testing
- FARAPULSE™ Pulsed Field Ablation System Plus
- Where
- 2 sites in Czechia
- Volunteers
- 80 people
- Sponsor
- Boston Scientific Corporation
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
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
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
Paroxysmal Atrial Fibrillation
Oral Anticoagulation Therapy Pilot Study
The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.
- Trial name
- OAT (NCT01959425)
- Testing
- Off OAT Group (Test), On OAT Group (Control)
- Volunteers
- 80 people
- Sponsor
- Biosense Webster, Inc.