Clinical trials: Pacemaker
Bradycardia
Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices.
- Trial name
- NCT04235491
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
ICD, Pacemaker
Postcards to Improve Remote Monitoring Connectivity Among Veterans With a Disconnected Monitor
We tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices who have lost continuous RM connectivity because of a disconnected home monitor.
- Conditions
- ICD, Pacemaker, Implanted Loop Recorder, Remote Monitoring
- Trial name
- NCT07464834
- Testing
- Tailored Postcard
- Where
- United States
- Volunteers
- 2,726 people
- Sponsor
- San Francisco VA Health Care System
Temporary Cardio-neural Pacing, Pacemaker Implantation
Cardioneural Temporary Pacing to Achieve Autonomic Modulation
Atrial fibrillation (AF) is the most common arrhythmia, with a lifetime risk of 1 in 3-5. In cases of rapid ventricular rate, patients often experience low blood pressure, making standard rate and rhythm control medications…
- Trial name
- NCT07247422
- Testing
- Temporary cardio-neural pacing
- Where
- Hong Kong
- Volunteers
- 33 people
- Sponsor
- Chinese University of Hong Kong
Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.
Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
- Trial name
- ANSWER (NCT00562107)
- Testing
- Symphony DR 2550 and REPLY DR cardiac pacemakers
- Where
- 37 sites in United States, France and 4 more
- Volunteers
- 650 people
- Sponsor
- LivaNova
Pacemaker, ICD
Monaldi Hospital Rhythm Registry
The study is a prospective registry. Consecutive patients with indications of implant / replacement or upgrade of pacemaker (PM), implantable cardioverter defibrillator (ICD), Implanted loop recorder (ILR) will be enrolled.
- Conditions
- Pacemaker, ICD, Implanted Loop Recorder
- Trial name
- NCT05072119
- Testing
- Device implantation
- Where
- Italy
- Volunteers
- 5,000 people
- Sponsor
- University of Campania Luigi Vanvitelli
Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity.
- Conditions
- Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block, Postoperative Complete Heart Block
- Trial name
- NCT01477658
- Where
- Brazil
- Volunteers
- 140 people
- Sponsor
- University of Sao Paulo
Heart Diseases
Safety of Cardiac Pacemakers in 1.5T Tesla MRI
To evaluate short-term and long-term effects by MR imaging on the technical and functional status of Medtronic pacemakers.
- Trial name
- NCT00336011
- Testing
- Magnetic resonance imaging
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- University Hospital, Bonn
Congenital Diseases, Complete Heart Block
Exercise in Chronically Paced Children
The purpose of this study is to evaluate the exercise capacity of patients with complete heart block who are chronically being paced from the right ventricle.
- Conditions
- Congenital Diseases, Complete Heart Block, Pacemaker
- Trial name
- NCT00374608
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Emory University
Leadless Pacemaker
Aveir Leadless Pacemaker Japan PMS
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing.
- Trial name
- NCT07106788
- Testing
- Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients, Upgrades
- Where
- 14 sites in Japan
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices
Pacemaker, Bradycardia
Adapta Pacing System Clinical Study
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow).
- Trial name
- NCT00307073
- Testing
- Implantable Pulse Generator
- Where
- 7 sites in Austria, Czechia and 4 more
- Volunteers
- 120 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Arrhythmia, Atrial Tachycardia
ATrial Tachycardia PAcing Therapy in Congenital Heart
Congenital heart disease (CHD) affects approximately 1% of newborns in the US, with 25% of those affected having critical conditions requiring open heart surgery within one year of birth.
- Conditions
- Atrial Arrhythmia, Atrial Tachycardia, Congenital Heart Disease, Pacemaker Re-Entrant Tachycardia
- Trial name
- AT-PATCH (NCT03209583)
- Testing
- Medtronic
- Where
- 15 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- Ian Law
Atrial Fibrillation, Bradycardia
Study for Atrial Fibrillation Reduction (SAFARI)
Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat.
- Trial name
- NCT00267137
- Testing
- Pacing Algorithms
- Where
- 34 sites in United States
- Volunteers
- 540 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Heart Block, Aortic Stenosis
Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).
The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in…
- Conditions
- Heart Block, Aortic Stenosis, Bundle-Branch Block
- Trial name
- GLUCO-TAVR (NCT06076824)
- Testing
- Methylprednisolone
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital General Universitario de Alicante
Magnetic Resonance Imaging, Cardiac Pacemaker, Artificial
Advisa MRI Clinical Study
The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR)…
- Trial name
- NCT01110915
- Testing
- Medtronic Advisa MRI Implantable Pulse Generator (IPG), Medtronic CapSureFix MRI™ active fixation MRI lead
- Where
- 37 sites in United States, Australia and 11 more
- Volunteers
- 269 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congenital Heart Disease, Bradycardia Sinus
Specialized Pacing for Patients With Congenital Heart Disease
The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing…
- Trial name
- NCT03361189
- Testing
- Closed loop stimulation, Standard rate response
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, Los Angeles
Syncope, Heart Block
Syncope: Pacing or Recording in the Later Years
Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all emergency room visits, and probably is responsible for CDN $250 million in health care spending each year.
- Conditions
- Syncope, Heart Block, Conduction Disorder of the Heart
- Trial name
- Spritely (NCT01423994)
- Testing
- pacemaker, implantable loop recorder
- Where
- 17 sites in United States, Canada and 3 more
- Volunteers
- 120 people
- Sponsor
- Canadian Institutes of Health Research (CIHR)
Analgesia After Pacemaker, AICDS Implantation Pediatrics
Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a…
- Trial name
- NCT04184349
- Testing
- LA group, B Group
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center, Houston
Patient Safety
An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans
This study will evaluate if an intervention using academic detailing and audit and feedback impacts the specific pacemaker or implantable cardioverter-defibrillator (ICD) lead models implanted in Veterans.
- Trial name
- Veteran CIEDs (NCT05062434)
- Testing
- Academic detailing and audit and feedback intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- VA Office of Research and Development
Congenital Heart Disease
The Effects of Telerehabilitation and Exercise Training in Pediatric Arrhythmia Patients With Pacemakers
There is no study evaluating online exercise training and results in children with pacemakers. This study investigates the effects of group exercise training performed via computer online videoconferencing in pediatric arrhythmia…
- Trial name
- NCT05454501
- Testing
- Exercise Training, Patient Education
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people
- Sponsor
- Hacettepe University
Heart Diseases
Safety of Cardiac Pacemakers in 3 Tesla MRI
To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.
- Trial name
- NCT00356330
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- University Hospital, Bonn