Clinical trials: Sinus Node Disease.
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 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
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
Gastrointestinal Disease, Anemia
Safety of Capsule Endoscopy in Patients With Implantable Cardiac Devices
This is a prospective study designed to assess safety and potential influence of the MiroCam on cardiac pacemaker and implantable cardiac defibrillator.
- Trial name
- NCT01360502
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- Yonsei University
Atrial Fibrillation
Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction
The study aims to evaluate the following: 1) the incidence of new onset atrial fibrillation in patients with an atrial leadless pacemaker, 2) the need for upgrade from a standalone atrial leadless pacemaker to a dual chamber…
- Trial name
- NCT07638995
- Testing
- Implantable Loop Recorder
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Northwell Health
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
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
POLish Registry of CArdioneuroablation and CArdioneuromodulation
The multicentre observational study POL-CA involves a wide spectrum of patients with a history of syncopy. The study recruits patients with diagnosed vasovagal syndrome, cardioinhibitory carotid sinus syndrome, symptomatic sinus…
- Conditions
- Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS, Symptomatic Sinus Bradycardia SB or Atrioventricular Block AV, Postural Orthostatic Tachycardia Syndrome POTS
- Trial name
- POL-CA (NCT07196397)
- Testing
- cardioneuroablation, SN sparing hybrid ablation, Cardiac sympathetic denervation
- Where
- Poland
- Volunteers
- 1,000 people
- Sponsor
- SABAMED Medical Center Ltd.
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 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
Decompensated Heart Failure
Control of Sinus Node Tachycardia as an Additional Therapy in Patients With Decompensated Heart Failure
Study aims to compare the I(f) inhibitor ivabradine with placebo as strategy of heart rate control in patients with decompensated heart failure (DHF).
- Trial name
- CONSTATHE (NCT02236247)
- Testing
- ivabradine
- Where
- Brazil
- Volunteers
- 50 people
- Sponsor
- University of Sao Paulo
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
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
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., 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
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
Heart Failure, Cardiac Resynchronization Therapy
Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm
The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium.
- Trial name
- BIO|REDUCE (NCT03839121)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 21 sites in Austria, Czechia and 2 more
- Volunteers
- 113 people
- Sponsor
- Biotronik SE & Co. KG
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
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