Clinical trials: Pacemaker
Pacemaker Indication
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and…
- Trial name
- NCT00916344
- Testing
- EVIA Pacemaker
- Where
- France
- Volunteers
- 175 people
- Sponsor
- Biotronik SE & Co. KG
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
Dilated Cardiomyopathy, Pediatric
Resynchronization Therapy in Young Patients With and Without CHD
Pacemakers can be attached to one or more than one of the heart chambers. After watching pacemakers work over time, doctors have found that the pacemakers that stimulate only one chamber of the heart sometimes lead to problems…
- Trial name
- NCT00208806
- Testing
- congestive heart failure patients
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Emory University
Arrhythmias, Cardiac
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
- Trial name
- NCT01130896
- Where
- United States
- Volunteers
- 1,509 people
- Sponsor
- Johns Hopkins University
Heart Block, Heart Block Complete
Effect of Site of Right Ventricular (RV) Pacing on RV Function, Left Ventricular (LV) Dyssynchrony and Contraction Efficiency
To evaluate RV systolic function and LV mechanical dyssynchrony and function in different lead position in the RV during permanent pacemaker implantation by using speckle tracking echocardiography (STE) and 3D volumetric ejection…
- Conditions
- Heart Block, Heart Block Complete, Systolic Function
- Trial name
- NCT06636851
- Testing
- Pacemaker and defibrillator
- Where
- Egypt
- Volunteers
- 52 people
- Sponsor
- South Valley University
Depression, Anxiety
The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study
The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has substantially changed the medical and surgical management of patients with cardiac rhythm disease.
- Conditions
- Depression, Anxiety, Post-traumatic Stress Disorder
- Trial name
- IDEAS (NCT01040988)
- Where
- United States
- Volunteers
- 166 people
- Sponsor
- Boston Children's Hospital
Bradycardia
Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
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
- Micra CED (NCT03039712)
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
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
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
ICD, Pacemaker DDD
Postcards to Improve Remote Monitoring Adherence Among Veterans
We tested the effect of informational postcards on improving remote monitoring adherence among Veterans with pacemakers and implantable cardioverter-defibrillators in a stepped-wedge randomized controlled trial.
- Conditions
- ICD, Pacemaker DDD, Adherence, Patient
- Trial name
- NCT06068699
- Testing
- Postcard
- Where
- United States
- Volunteers
- 6,351 people
- Sponsor
- US Department of Veterans Affairs
Patients Above 18 Years, Patient Discharge
One Year Pacing Dependency After TAVR
Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and…
- Conditions
- Patients Above 18 Years, Patient Discharge, Pacing Therapy, Aortic Stenosis (Treated With TAVI)
- Trial name
- PACETAVI (NCT06756282)
- Testing
- Pacemaker and defibrillator
- Where
- France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Montpellier
Cardiac Pacemaker, Artificial, Implantable Cardioverter-Defibrillator
Actions Elicited by In-hospital Follow-up of Cardiac Devices
This study will enroll all patients who will attend an in-hospital follow-up of cardiac device since February 22nd 2010 to June 21st 2010.
- Trial name
- ATHENS (NCT01073449)
- Testing
- In-hospital follow-up of cardiac device
- Where
- 8 sites in Italy
- Volunteers
- 3,362 people
- Sponsor
- Cliniche Humanitas Gavazzeni
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
Pacemakers
PACE30: 30 Years in Cardiac Pacing
Limited data exist regarding temporal trends in permanent pacemaker (PPM) implantation. To describe trends in incidence and comorbidities of PPM recipients, the investigators aim to conduct a retrospective population-based cohort…
- Trial name
- PACE30 (NCT01086098)
- Volunteers
- 5,000 people
- Sponsor
- University of Dundee
Performing Bioimpedance Analysis
BIA and Cardiac Implantable Electronic Devices
There are an increase number of patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) worldwide.
- Trial name
- NCT03045822
- Testing
- Bioimpedance analysis
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Clermont-Ferrand
Sick Sinus Syndrome, Atrioventricular Block
Taiwan Registry for Leadless Pacemaker
Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.
- Trial name
- NCT04926792
- Testing
- Leadless Pacemaker
- Where
- Taiwan
- Volunteers
- 300 people
- Sponsor
- National Taiwan University Hospital
Cardioneuroablation, Permanent Pacemaker Implantation
Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome
Different studies for cardiac ganglionated plexus（GP） ablation to treat vagal vascular syncope, sinus node dysfunction, and functional atrioventricular block have been published.
- Conditions
- Cardioneuroablation, Permanent Pacemaker Implantation, Sick Sinus Syndrome, Ganglionated Plexus
- Trial name
- GAPS (NCT04149886)
- Testing
- cardiac ganglion plexus ablation(cardioneuroablation), Permanent pacemaker implantation
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- China National Center for Cardiovascular Diseases
Pacemaker, Defibrillators, Implantable
Complications Following Pacemaker or Implantable Defibrillator Cardioverter (ICD) Implantation in Denmark
This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD) implantation.
- Trial name
- NCT01138670
- Where
- Denmark
- Volunteers
- 5,500 people
- Sponsor
- University of Aarhus
Pacemaker Complication, Congestive Heart Failure
Optimised Pacing Program
Permanent pacemakers are a common treatment for slow heart beats. In the UK 300,000 people have a pacemaker, and each year another 36,000 receive them. All of these patients are usually seen yearly to have their device checked.
- Trial name
- OPT-pace (NCT01819662)
- Testing
- Enhanced standard management, Optimised heart failure management, Standard management
- Where
- 3 sites in United Kingdom
- Volunteers
- 1,793 people, healthy volunteers welcome
- Sponsor
- University of Leeds
Educational Activities
The Effect Of Education Given According to Meleıs' Transitional Theory to Patients With Pacemaker
This study will be carried out to determine the effect of training given according to Meleis's Transition Theory to patients with pacemaker implantation on anxiety, depression and self-efficacy levels.
- Trial name
- NCT06204601
- Testing
- Education According to Meleis' Transitional Theory to Patients With Pacemaker
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Ordu University