Clinical trials: Cardiac Pacemaker
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
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
Heart Failure, Dilated Cardiomyopathy
PITA-HF: Feasibility, Safety, and Tolerability
Heart failure affects over 25 million people worldwide and nearly 7 million adults in the United States alone. Nearly 25% of patients with heart failure have worsened disease burden from dyssynchronous ventricular contraction due…
- Trial name
- NCT04159454
- Testing
- PITA
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Johns Hopkins University
Heart Block, Bradycardia
iPod and Other MP3 Players on ICDs and Pacemakers in Children
Unlike phones, which are commonly held to the ear, music is now available via portable MP3 players and they can be held almost anywhere.
- Conditions
- Heart Block, Bradycardia, Tachycardia, Arrhythmia
- Trial name
- NCT00542854
- Testing
- MP3
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Children's Hospital
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
Chronically (i.e. Implanted for at Least Six Months) Dual-chamber Pacemaker, Stable Cardiac Status (i.e. no Hospitalizations or Cardiac Medication Changes Within 3 Months)
Short Atrioventricular Delay Pacing
We intend to examine the effects of temporary elevation of atrial wall stress by shortening of the atrioventricular delay in patients with dual-chamber pacemakers.
- Trial name
- SAVD (NCT01233661)
- Testing
- short AVD pacing ; prior (stable) programming
- Where
- United States
- Sponsor
- University of Pittsburgh
Bradycardia Sinus, AV Block
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location.
- Conditions
- Bradycardia Sinus, AV Block, Atrial Fibrillation (AF)
- Trial name
- NCT06910059
- Testing
- Observational
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiomyopathy, Cardiac Arrhythmia
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals…
- Conditions
- Cardiomyopathy, Cardiac Arrhythmia, Heart Failure, Chronic Thromboembolic Pulmonary Hypertension
- Trial name
- RF (NCT02111980)
- Testing
- RF Assure Scanning
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
Reflex Syncope
Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
Reflex syncope is the most common form of syncope. It can lead to injuries and affect quality of life. Nonpharmacological and medical therapies have limited effectiveness.
- Trial name
- PANACEA (NCT05855603)
- Testing
- Cardioneuroablation, Permanent pacemaker therapy
- Where
- 10 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
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
Heart Failure, Cardiac Resynchronisation Pacemakers
Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
An evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers.
- Trial name
- CHOICE2 (NCT01055210)
- Testing
- Optimisation of VV delay
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- University of Dundee
Sick Sinus Node Syndrome
Model 20105 Lead Study
The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.
- Trial name
- NCT02301429
- Testing
- Model 20105
- Where
- 4 sites in Canada, Netherlands and 2 more
- Volunteers
- 16 people
- Sponsor
- Medtronic BRC
Blood Pressure
Long-term Atrial Pacing and Central Blood Pressure
This is a randomized controlled single-centre clinical trial with a cross-over design to compare non-invasively evaluated central blood pressure and related parametres in sick sinus syndrome patients with hypertension who are…
- Trial name
- NCT04309175
- Testing
- base rate programming of a permanent cardiac pacemaker
- Volunteers
- 58 people
- Sponsor
- Tartu University Hospital
MRI, Pacemaker
University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices
A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).
- Conditions
- MRI, Pacemaker, Defibrillator
- Trial name
- CDMR (NCT02548819)
- Testing
- MRI
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- University Health Care System, Augusta, Georgia
Magnetic Resonance Imaging (MRI)
Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging
Researchers are trying to determine if heart injury occurs in subjects with cardiac implantable electronic device (CIED), such as a pacemaker or implantable cardioverter defibrillator (ICD), who undergo a magnetic resonance…
- Trial name
- NCT04151953
- Testing
- Blood sample collection
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- Mayo Clinic
Pacemaker Therapy, Cardiac Resynchronization Therapy
BIO|MASTER.Edora Family Study
This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions.
- Trial name
- NCT03091322
- Testing
- Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
- Where
- 11 sites in Austria, Germany and 2 more
- Volunteers
- 120 people
- Sponsor
- Biotronik SE & Co. KG
Pacemaker, Implantable Cardioverter-defibrillator
Ultrasound-guided Axillary Versus Conventional Cephalic Venous Access for Implantation of Cardiac Devices
The implantation of cardiac electronic devices is a common procedure in the Electrophysiology Laboratory. The most commonly used venous access sites are the cephalic, the axillary and the subclavian vein.
- Trial name
- NCT04958369
- Testing
- Ultrasound-guided axillary venous access, Cephalic venous access
- Where
- Greece
- Volunteers
- 114 people
- Sponsor
- University Hospital of Patras
Bradycardia, Heart Failure
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt…
- Trial name
- NCT06018818
- Testing
- Amvia/Solvia pacemaker family
- Where
- 3 sites in Austria, Germany
- Volunteers
- 129 people
- Sponsor
- Biotronik SE & Co. KG
Heart Disease, Cardiovascular Disease
Remote Device Interrogation In The Emergency Department
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REMEDY (NCT01871090)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
Bradycardia
ULTRA Study for Pacemaker Patients
The ULTRA study will assess the difference in average ventricular voltage output for pacemaker patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF.
- Trial name
- NCT00133289
- Testing
- Pacemaker with Automatic Capture
- Where
- United States
- Volunteers
- 950 people
- Sponsor
- Boston Scientific Corporation