Clinical trials: Pacemaker
PM Implantation After TAVR
Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
Hypothesis of the study is that a modified and improved implantation protocol (regarding membranous septum length and implantation depth) will decrease the need for permanent pacemaker stimulation follow TAVR-procedures.
- Trial name
- MIDAS - ULM (NCT04734392)
- Testing
- TAVR
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- University of Ulm
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
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
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
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
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
Hypertrophic Cardiomyopathy
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement
Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure. A temporary pacing is necessary in patients after cardiac procedures.
- Trial name
- BIVENT (NCT01081093)
- Testing
- additional temporary pacewire
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
Bradyarrhythmia
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
- Trial name
- OPTI-MIND 2 (NCT01715558)
- Where
- 39 sites in Belgium, Denmark and 7 more
- Volunteers
- 514 people
- Sponsor
- Boston Scientific Corporation
Symptomatic Aortic Valve Stenosis
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI
The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study.
- Trial name
- NCT01801098
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Bradyarrhythmia
Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes
Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart.
- Trial name
- PACMAN (NCT01897558)
- Testing
- Pacemaker implantation
- Where
- 5 sites in Croatia, Germany and 1 more
- Volunteers
- 290 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Leadless Pacemaker, Bradycardia
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according…
- Conditions
- Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
- Trial name
- BIO-LivIQ (NCT07118358)
- Testing
- LivIQ Leadless Pacemaker System
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 325 people
- Sponsor
- Biotronik, Inc.
Hypertension, Atrial Fibrillation
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.
- Trial name
- NCT00256152
- Testing
- AF Suppression Pacing Algorithm
- Where
- Canada
- Volunteers
- 2,580 people
- Sponsor
- Abbott Medical Devices
Syncope, Vasovagal
Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)
Physiological stimulation therapy effectiveness will be proved with contractility sensor or CLS sensor (Closed Loop Stimulation), in BIOTRONIK CLS pacemakers to prevent from neuromediated syncope.
- Trial name
- SPAIN (NCT01621464)
- Testing
- Pacemaker with Closed Loop Stimulation (CLS sensor)
- Where
- Spain
- Volunteers
- 55 people
- Sponsor
- Spanish Society of Cardiology
Physical Activity, Pacemaker
Physical Activity and Pacemaker Study
The benefits of regular physical activity are well-established. Furthermore, the investigators have previously shown that in a population of patients with implanted pacemakers, those who exercise more than 2 hours daily have…
- Conditions
- Physical Activity, Pacemaker, Cardiovascular Diseases, Arrythmia
- Trial name
- NCT03052829
- Testing
- Physical activity counseling, Usual care
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Medical College of Wisconsin