Clinical trials: Cardiac Pacemaker
Block Complete Heart, Atrial Fibrillation
International Ledless Pacemaker Registry
The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers.
- Trial name
- i-LEAPER (NCT05528029)
- Testing
- Leadless Pacemaker (Micra)
- Where
- 12 sites in Belgium, Italy and 1 more
- Volunteers
- 2,000 people
- Sponsor
- Luigi Sacco University Hospital
Arrhythmia, Cardiovascular Diseases
Mode Selection Trial in Sinus Node Dysfunction (MOST)
To determine if dual chamber rate-modulated pacing (DDDR) in patients with sick sinus syndrome is superior to single chamber pacing (VVIR) with respect to subsequent frequency of adverse clinical events such as stroke, quality of…
- Conditions
- Arrhythmia, Cardiovascular Diseases, Heart Diseases, Sick Sinus Syndrome
- Trial name
- NCT00000561
- Testing
- pacemaker, artificial
- Sponsor
- Mt. Sinai Medical Center, Miami
Tricuspid Regurgitation, Pacemaker
Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes
Tricuspid regurgitation (TR) is a common complication following cardiac implantable electronic device (CIED) implantation, with severe TR being associated with increased rates of heart failure hospitalization and all-cause…
- Trial name
- NCT06922526
- Testing
- Pacemaker implantation
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Haiyan Wang
Syncope, Pacemaker
Syncope-Asystole Latency Time in Tilt Table Test: The SALT-TILT Study
Syncope is a common presenting condition. Pacemaker implantation can significantly reduce syncope recurrences in reflex syncope.
- Conditions
- Syncope, Pacemaker, Asystole, Neurally Mediated Syncope
- Trial name
- SALT-TILT (NCT06356207)
- Testing
- Tilt Table Test
- Where
- Italy
- Volunteers
- 64 people
- Sponsor
- Azienda Ospedaliera di Bolzano
Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
ProMRI PROVEN Master Study
This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker…
- Trial name
- NCT01809665
- Testing
- ICD/CRT-P therapy, MRI
- Where
- 23 sites in Australia, Austria and 6 more
- Volunteers
- 174 people
- Sponsor
- Biotronik SE & Co. KG
Pacing Therapy, Cardiac Pacing
Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction
This study aims to evaluate whether posterosuperior bundle (PSB) pacing reduces the incidence of atrial fibrillation (AF) in patients with sinus node dysfunction (SND) undergoing pacemaker implantation.
- Trial name
- PSB-AF (NCT07645066)
- Testing
- RAA pacing, PSB pacing
- Where
- 10 sites in China
- Volunteers
- 300 people
- Sponsor
- Shanghai Tong Ren Hospital
Electromagnetic Interference
Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI).
- Trial name
- NCT01369706
- Testing
- Hand-held metal detector
- Where
- 2 sites in Germany, Greece
- Volunteers
- 388 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Bradycardia
Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients (RESPIRE)
The purpose of the study is to evaluate at 12 Months follow-up the association between Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in REPLY 200 DR pacemaker.
- Trial name
- NCT01922726
- Where
- Spain
- Volunteers
- 1,257 people
- Sponsor
- MicroPort CRM
Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines
Comparison of AAIsafeR and DDD Modes in Non-selected Patients
1 Purpose In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers…
- Trial name
- CAN-SAVE R (NCT01219621)
- Testing
- Symphony Dual Chamber Rate Responsive Device
- Where
- 10 sites in Canada
- Volunteers
- 450 people
- Sponsor
- Sorin Group Canada
Atrial Fibrillation
Subclinical AtrIal FibrilLation and StrokE PreveNtion Trial
Introduction: Patients with atrial fibrillation (AF) have a substantial risk of stroke and systemic embolism. Subclinical AF is often suspected to be the cause of stroke in these patients.
- Trial name
- SILENT (NCT02004509)
- Testing
- Anticoagulant
- Where
- Brazil
- Volunteers
- 2,054 people
- Sponsor
- InCor Heart Institute
Heart Failure With a Preserved Ejection Fraction, Heart Failure, Diastolic
Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).
- Conditions
- Heart Failure With a Preserved Ejection Fraction, Heart Failure, Diastolic, Chronotropic Incompetence
- Trial name
- RAPID-HF (NCT02145351)
- Testing
- Rate adaptive atrial pacing using a dual-chamber pacemaker, Pacemaker system will be implanted but set to Pacing Off.
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Mayo Clinic
Atrioventricular Block, Second and Third Degree
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic…
- Trial name
- PACE-4-TAVI (NCT05966675)
- Testing
- conduction system pacing, right ventricular or biventricular pacing
- Where
- Poland
- Volunteers
- 500 people
- Sponsor
- Medical University of Silesia
Heart Failure, Systolic, Pacemaker
Optimising Pacing for Contractility 2
The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF).
- Trial name
- OPT-cont 2 (NCT04201015)
- Testing
- Heart rate optimisation using force frequency data
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- University of Leeds
Bradyarrhythmia
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.
- Trial name
- NCT01522755
- Testing
- Pacing system implant with the CapsureFix MRI pacing lead model 5086
- Where
- France
- Volunteers
- 409 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Fibrosis, Atrial Fibrillation
Myocardial Fibrosis in Patients With Permanent Pacemakers
Patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation will be included in the study.
- Conditions
- Fibrosis, Atrial Fibrillation, Atrial Flutter
- Trial name
- NCT05920226
- Testing
- pacemakers implantation and assessment of cardiac function and cardiac fibrosis, assessment of cardiac function and cardiac fibrosis
- Where
- Russia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Ryazan State Medical University
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
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
Sinus Bradycardia, Sinus Node Disease
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
- Conditions
- Sinus Bradycardia, Sinus Node Disease, Atrio-ventricular Block
- Trial name
- IES-ACap (NCT00832260)
- Volunteers
- 70 people
- Sponsor
- Abbott Medical Devices
Recipients of Implantable Pacemakers or Defibrillators
Safety of Smartphones Among Patients With Cardiac Implantable Electronic Devices
Over the past year smartphones have developed from a niche product to a commoditized product and are now squeezing classic mobile phones out of market.
- Trial name
- NCT01819896
- Testing
- Pacemaker and defibrillator
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Bradycardia
Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect…
- Trial name
- PREMS (NCT02174484)
- Where
- 49 sites in France
- Volunteers
- 571 people
- Sponsor
- Biotronik SE & Co. KG