Clinical trials: Sick Sinus Node Syndrome
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
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
Cardiac Pacemaker, Cardiac Rhythm Disorder
LEAP 2 Chronic EFS
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT07287423
- Testing
- AVEIR CSP Leadless Pacemaker System
- Where
- Czechia
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Bradycardia
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate…
- Trial name
- CLEAR (NCT00355797)
- Testing
- Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
- Where
- 99 sites in United States
- Volunteers
- 1,491 people
- Sponsor
- Biotronik, Inc.
Sinus-node Dysfunction
Right Ventricular Outflow Tract Study
This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path…
- Trial name
- RVOTCARE (NCT01294839)
- Testing
- Right ventricular lead location
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Bradycardia
Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class
This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be…
- Conditions
- Atrial Fibrillation, Bradycardia, Heart Block, Sick Sinus Syndrome
- Trial name
- NCT00292539
- Testing
- Any pacemaker with right ventricular pacing option
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- Guidant Corporation
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, 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
Sinus Node Dysfunction, Bradycardia-Tachycardia Syndrome
Spontaneous Atrio Ventricular Conduction Preservation
In case of sinus node dysfunction, it is often necessary to choose the safer option provided by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode.
- Conditions
- Sinus Node Dysfunction, Bradycardia-Tachycardia Syndrome, Paroxysmal Atrioventricular Block
- Trial name
- SAVER (NCT00655213)
- Testing
- Symphony D 2450, Symphony DR 2550
- Where
- 67 sites in Belgium, France and 3 more
- Volunteers
- 622 people
- Sponsor
- LivaNova
Bradycardia, Sinus Node Dysfunction
LBBAP Data Collection Registry
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT05887323
- Testing
- Implantation of the Tendril 2088 lead in the LBBA
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 221 people
- Sponsor
- Abbott Medical Devices
Sinus Node Disease
To Pace or Not to Pace in Sinus Node Disease
Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing.
- Trial name
- OPTIMIST (NCT02485093)
- Testing
- Septal ventricular pacing, VIP
- Where
- France
- Volunteers
- 215 people
- Sponsor
- Abbott Medical Devices
Death, Sudden, Cardiac, Ventricular Fibrillation
Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
To generate a list of potential genetic markers that correlate with an increased risk of life-threatening arrhythmias. To evaluate ECG-based risk markers such as heart rate variability and T-wave Alternans for their association…
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation
- Trial name
- GAME (NCT00664807)
- Where
- United States
- Volunteers
- 1,023 people
- Sponsor
- Medtronic Corporate Technologies and New Ventures
Bradycardia; Sick Sinus Syndrome, AV Block
Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.
- Trial name
- NCT00156741
- Testing
- Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2, Required pacemaker setting
- Where
- 30 sites in Austria, Czechia and 9 more
- Volunteers
- 150 people
- Sponsor
- Medtronic BRC
Atrial Fibrillation
SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation
This is a randomized, parallel, single-blinded multi-center study. The objective is to compare the long term clinical outcomes among the site of atrial pacing and to compare the long term effect of the atrial fibrillation (AF)…
- Trial name
- SAFE (NCT00419640)
- Testing
- Pacemaker implantation with RA lead in LAS position, Pacemaker implantation with RA lead in RAA position
- Where
- Hong Kong
- Volunteers
- 385 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Heart Block
Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated.
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome
- Trial name
- NCT00180557
- Testing
- Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip
- Where
- Austria
- Volunteers
- 120 people
- Sponsor
- Guidant Corporation
Sinus Node Dysfunction, Brady Tachy Syndrome
Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
- Trial name
- NCT01170611
- Testing
- PACEMAKER SYMPHONY 2550
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 400 people
- Sponsor
- LivaNova
Bradycardia, Atrioventricular Block
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in…
- Conditions
- Bradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block
- Trial name
- SEPTA PMCF (NCT07209852)
- Testing
- Pacemaker lead
- Where
- 13 sites in Belgium, France and 5 more
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
Bradycardia, Sinus Node Dysfunction
ImageReady(TM) MR Conditional Pacing System Clinical Study
The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with…
- Trial name
- SAMURAI (NCT01781078)
- Testing
- MRI, ImageReady System implant
- Where
- 41 sites in United States, Australia and 5 more
- Volunteers
- 363 people
- Sponsor
- Boston Scientific Corporation
Sick Sinus Syndrome, Heart Failure, Congestive
SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction
SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent…
- Conditions
- Sick Sinus Syndrome, Heart Failure, Congestive, Atrial Fibrillation, Bradycardia
- Trial name
- SAVEPACe (NCT00284830)
- Testing
- Implantable Pulse Generators
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,070 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sinus Node Disease, Atrioventricular Block
BIO|STREAM.CSP CLS
This clinical study is a prospective, observational submodule of the BIO|STREAM.CSP registry designed to evaluate clinical outcomes in patients receiving BIOTRONIK dual-chamber pacemakers that combine conduction system…
- Trial name
- NCT07608822
- Testing
- Left bundle branch area pacing with Closed Loop Stimulation
- Where
- 12 sites in Czechia, Hungary and 3 more
- Volunteers
- 150 people
- Sponsor
- Biotronik SE & Co. KG