Clinical trials: Sinus-node Dysfunction
Bradycardia
Falls and Cardiovascular Events in Pacemaker Patients
The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.
- Trial name
- NCT01037426
- Testing
- Fill out Questionnaire
- Where
- 8 sites in Switzerland
- Volunteers
- 87 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Atrial Flutter
Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism and Thrombosis
- Trial name
- SAFE-VEIN (NCT04632641)
- Testing
- Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES, Figure 8 Suture - LARGE-BORE PROCEDURES
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Wake Forest University Health Sciences
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
Sinus Arrhythmia, Atrial Fibrillation
Electrophysiologically Guided PAcing Site Selection Study
This study is a long-term, prospective, and controlled evaluation of the incidence of persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction delay paced with preventive algorithms at the…
- Trial name
- EPASS (NCT00239226)
- Testing
- IAS pacing - study group, IAS pacing control group, Pacing RAA study group
- Where
- 8 sites in Italy
- Volunteers
- 102 people
- Sponsor
- Medtronic BRC
Arrhythmia, Sinus Node Disease
PANORAMA Observational Study
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy)…
- Conditions
- Arrhythmia, Sinus Node Disease, Heart Failure, Heart Block
- Trial name
- NCT00382525
- Testing
- Cardiac Rhythm Management device
- Where
- 27 sites in Belgium, India and 4 more
- Volunteers
- 8,586 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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.
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
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
Sinus Node Dysfunction, Sick Sinus Syndrome
Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction
Endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (VV), functional atrioventricular block (AVB) and sinus node dysfunction (SND) with a…
- Trial name
- DINERVAPACE (NCT05186220)
- Testing
- Cardioneuroablation, Permanent dual chamber pacemaker implantation
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Hospital Clinico Universitario de Santiago
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
Sick Sinus Syndrome, Atrioventricular Nodal Dysfunction
Left Bundle Branch Versus Minimized Ventricular Pacing in Patients With Sick Sinus Syndrome and Prolonged AV Interval
The goal of this clinical trial is to compare two pacemaker strategies: Left Bundle Branch Area Pacing (LBBAP) and Minimized Ventricular Pacing (MVP) in patients requiring a permanent pacemaker for sick sinus syndrome and…
- Trial name
- CLOSE-AV (NCT07314008)
- Testing
- LBBAP, MVP
- Where
- South Korea
- Volunteers
- 440 people
- Sponsor
- Asan Medical Center
Bradycardia, Sinus Node Dysfunction
Left Bundle Area Versus Selective His Bundle Pacing
This is a voluntary research study to find out which location in the heart a pacemaker wire is the most efficient for a patient's heart and for battery life.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Atrioventricular Block
- Trial name
- LEFTBASH (NCT04093414)
- Testing
- Select Secure pacing lead
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- David Haines, MD
Sinus Node Dysfunction, Heart Block AV
The Fluoroless-CSP Trial Using Electroanatomic Mapping
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster…
- Conditions
- Sinus Node Dysfunction, Heart Block AV, LBBB, Heart Failure, Systolic
- Trial name
- NCT03903107
- Testing
- Conventional fluoroscopy guided Conduction System Pacing(CSP), Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Rush University Medical Center
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., 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
Coronary Microvascular Disease, Cardiac Pacemaker Syndrome
The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
The study will examine role of transvenous pacing on coronary microcirculation.
- Trial name
- NCT03917251
- Testing
- Coronary flow and pressure measurement in patients with ventricular pacing
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Nebraska
Sinus Node Dysfunction
Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
This study is a prospective, non-randomized pilot study looking to evaluate the effectiveness of Closed Loop Stimulation (CLS) in sinus node dysfunction patients with HIS bundle placement.
- Trial name
- NCT03601754
- Testing
- Treadmill/Bicycle exercise testing
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- NYU Langone Health
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
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