Clinical trials: Pacemaker
Sick Sinus Syndrome, Brady-Tachy Syndrome
Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial fibrillation (AF).
- Trial name
- NCT00224341
- Testing
- Pacemaker Vitatron Selection 9000, Pacemaker Vitatron T70
- Where
- 37 sites in France
- Volunteers
- 360 people
- Sponsor
- Vitatron France
Bradycardia
SJM Brady MRI Post Approval Study
The purpose of this post approval study is to evaluate the long-term safety of the FDA approved St. Jude Medical Tendril MRI™ lead implanted with a SJM Brady MRI implantable pulse generator (IPG) such as the Accent MRI™, Assurity…
- Trial name
- Brady MRI PAS (NCT03170583)
- Testing
- St. Jude Medical Tendril MRI™ lead
- Where
- 66 sites in United States
- Volunteers
- 1,768 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden
The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent…
- Trial name
- NCT01356914
- Testing
- BMS-914392
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Bristol-Myers Squibb
Tunisian Patients Already Implanted With a TAVI
Tunisian Registry of Trans Catheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement.
- Trial name
- TAVI-TN (NCT06503965)
- Where
- Tunisia
- Volunteers
- 300 people
- Sponsor
- Les Laboratoires des Médicaments Stériles
Atrioventricular Block, Heart Diseases
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- BLOCK HF (NCT00267098)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 54 sites in United States, Canada
- Volunteers
- 918 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Indications for VVI(R) Pacemaker
The LEADLESS Observational Study
The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.
- Trial name
- NCT02051972
- Testing
- Implanted with a Nanostim leadless pacemaker system
- Where
- 32 sites in Czechia, France and 5 more
- Volunteers
- 491 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Atrial Fibrillation
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.
- Trial name
- PAFOS (NCT01912326)
- Testing
- Pacemaker Implantation
- Where
- Germany
- Volunteers
- 249 people
- Sponsor
- Abbott Medical Devices
Pacemaker, Bradycardia
VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies
The purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers.
- Trial name
- NCT00294034
- Testing
- Pacemaker
- Where
- 27 sites in United States
- Volunteers
- 950 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Dual-chamber Pacemaker Placement
Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing System
Permanent cardiac pacemakers have represented a contraindication to Magnetic Resonance Imaging (MRI). Strong static, gradient and radiofrequency fields used for MRI are thought to be detrimental to pacemaker function and possibly…
- Trial name
- NCT01341522
- Testing
- MRI exam, control
- Sponsor
- LivaNova
Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
ProMRI Study of the Entovis Pacemaker System
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.
- Trial name
- NCT01761162
- Testing
- Patients with a ProMRI Pacemaker System, Magnetic Resonance Imaging (MRI) scan
- Where
- 25 sites in United States
- Volunteers
- 229 people
- Sponsor
- Biotronik, Inc.
Bradycardia
LIFE Study - Limiting Chronotropic Incompetence for Pacemaker Recipients
This study will compare how two different sensors inside the pacemaker may affect patients' quality of life.
- Trial name
- NCT00146861
- Testing
- sensor programming
- Volunteers
- 1,500 people
- Sponsor
- Boston Scientific Corporation
Cardiovascular Diseases
PreFER Managed Ventricular Pacing (MVP) For Elective Replacement
The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.
- Trial name
- NCT00293241
- Testing
- Managed Ventricular Pacing programmed ON/OFF
- Where
- Netherlands
- Volunteers
- 630 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Indication for Cardiac Resynchronization Therapy (CRT)
Evia/Entovis HF-T Master Study
The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers.
- Trial name
- NCT01545739
- Testing
- Evia/Entovis HF-T pacemaker for CRT therapy
- Where
- Hungary
- Volunteers
- 122 people
- Sponsor
- Biotronik SE & Co. KG
Hypertension
Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients
The purpose of this study is to test whether the A-V sequential pacing strategy shown to effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure acutely in patients with hypertension (systolic…
- Trial name
- NCT02382484
- Testing
- A dual chamber pacing system (BackBeat Medical)
- Where
- China
- Volunteers
- 19 people
- Sponsor
- BackBeat Medical Inc
Bradycardia
P3: Pacemaker Patient Profiling Study
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.
- Trial name
- NCT00294060
- Where
- 83 sites in United States
- Volunteers
- 2,013 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
SITELINE 2 Polyurethane
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
- Trial name
- NCT00180284
- Testing
- SITELINE 2 Polyurethane (pacing lead)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Syncope, Syncope, Vasovagal
Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial
The purpose of this study is to explore changes in patients' hemodynamic parameters during the Head-Up Tilt Test ("HUTT") and their timing with respect to onset of the Closed Loop Stimulation (CLS) pacing.
- Trial name
- BIO|Sync-HUTT (NCT06038708)
- Where
- 2 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia, Remote Monitoring
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.
- Trial name
- CALLIOPE (NCT05165095)
- Testing
- Pacemaker implantation
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 206 people
- Sponsor
- MicroPort CRM
Cardiac Pacemaker Syndrome
Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.
- Trial name
- NCT00943046
- Testing
- Pacemaker therapy
- Where
- Germany
- Volunteers
- 164 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers
The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker.
- Trial name
- NCT00389792
- Testing
- ATI-2042, ATI-2042 200 mg
- Where
- 40 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- ARYx Therapeutics