Clinical trials: Sinus Sick Syndrome
Sinus Node Dysfunction, Bradycardia
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA).
- Conditions
- Sinus Node Dysfunction, Bradycardia, Atrioventricular Block
- Trial name
- BIO-CONDUCT (NCT06540079)
- Testing
- Solia CSP S lead
- Where
- 10 sites in United States
- Volunteers
- 192 people
- Sponsor
- Biotronik, Inc.
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.
Arrhythmia, Sinus
EnTRINSIC - EnPulse Trial on Search AV+ Influence
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction.
- Trial name
- NCT00157794
- Testing
- Search AV+ algorithm
- Where
- 14 sites in Germany
- Volunteers
- 135 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
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
Left Ventricular Dysfunction, Cardiac Conduction Defect
Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum
Cardiac pacing is the only effective treatment for symptomatic bradycardia. The right ventricular apex (RVA) has become the most frequently used ventricular pacing site.
- Conditions
- Left Ventricular Dysfunction, Cardiac Conduction Defect, Heart Failure, Sick Sinus Syndrome
- Trial name
- NCT01609738
- Testing
- Left ventricular septum pacing lead
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Maastricht University Medical Center
Bradycardia, Syncope, Vasovagal
Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias
Bradyarrhythmias are conditions where the heart beats too slowly, causing symptoms like dizziness, fainting, and fatigue. In some patients, these slow heart rhythms are caused by overactivity of the vagus nerve (the part of the…
- Conditions
- Bradycardia, Syncope, Vasovagal, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- CRYO-CNA vs RF (NCT07671898)
- Testing
- Focal Cryoablation, Radiofrequency Catheter Ablation
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Sinus Node Disease
Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence…
- Trial name
- B3 (NCT02579889)
- Testing
- DDD+CLS, DDD(R)
- Where
- 54 sites in China, Hungary and 7 more
- Volunteers
- 1,390 people
- Sponsor
- Biotronik SE & Co. KG
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 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
Sinus Node Dysfunction
Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only.
- Trial name
- SANOK (NCT05196126)
- Testing
- Permament pacemaker implantation, Cardioneuroablation
- Where
- 4 sites in Poland
- Volunteers
- 60 people
- Sponsor
- Stec, Sebastian, MD, PhD, FESC
Bradycardia, Sinus Node Dysfunction
Safety and Performance Study of the INGEVITY Lead
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
- Trial name
- NCT01688843
- Testing
- INGEVITY lead
- Where
- 78 sites in United States, Australia and 14 more
- Volunteers
- 1,060 people
- Sponsor
- Boston Scientific 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
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
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
Bradycardia, Syncope
Cardioneuroablation for Bradyarrhythmia
This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker…
- Conditions
- Bradycardia, Syncope, Sick Sinus Syndrome
- Trial name
- CARDIOBOOST (NCT06288633)
- Testing
- Ganglionated plexi ablation, Electrophysiological study
- Where
- Russia
- Volunteers
- 106 people
- Sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sinus Node Disease., First Degree Atrioventricular Block.
Minimizing Ventricular Pacing
The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality…
- Trial name
- NCT01611389
- Testing
- Prolonging atrioventricular (AV) delay., Standard atrioventricular (AV) delay.
- Where
- Poland
- Volunteers
- 60 people
- Sponsor
- Military Institute od Medicine National Research Institute
Sick Sinus Syndrome, AV-Block
Left Ventricular Function and Remodelling During Permanent Pacing
1. Background - Pacemaker treatment gives asynchronous activation of the heart that often results in decreased heart function and clinical heart failure.
- Trial name
- NCT00228241
- Testing
- AAI vs. DDD vs. BIV pacing in different patients groups
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Aarhus University Hospital Skejby
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
Sick Sinus Syndrome, Complete Atrioventricular Block
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing single-chamber pacemaker implantation.
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block, Bradycardia
- Trial name
- ZF-PMSC (NCT03118440)
- Testing
- zero-fluoroscopy 3D navigation, conventional x-ray navigation
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital