Clinical trials: Sinus Node Disease.
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
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
Sinus Node Dysfunction
A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction
Providing ideal rate response to patients should improve their quality of life and ability to execute activities of daily living.
- Trial name
- CRIPS (NCT02027909)
- Testing
- Reprogramming dual chamber pacemaker
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Arun Rao
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 Bradycardia
Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia
This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia.
- Trial name
- NCT06276816
- Where
- China
- Volunteers
- 88 people
- Sponsor
- China National Center for Cardiovascular Diseases
Sinus Node Dysfunction
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
- Trial name
- IMPROVE Brady (NCT01643707)
- Testing
- Evidence based guidelines and tools
- Where
- 21 sites in Argentina, Bangladesh and 5 more
- Volunteers
- 1,342 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacemaker, Arrythmia
AVEIR DR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05932602
- Testing
- Aveir DR Leadless Pacemaker System, Dual Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 2,812 people
- Sponsor
- Abbott Medical Devices
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
Pacemaker Implantation for Sinus Node Disease
Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing
Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators. The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular…
- Trial name
- ADVANTAGE (NCT01803217)
- Testing
- pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Sinus Node Dysfunction
Allometric-Pace Study
The goal of this observational study is to improve quality of life in sinus node dysfunction patients by utilizing allometric lower rate pacing (or called personalized lower rate, PLR) in standard commercially available…
- Trial name
- NCT05766462
- Testing
- Pacemaker lower rate setting
- Where
- 3 sites in China
- Volunteers
- 73 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sinus Node Disease, Atrioventricular; Block, Second Degree (Types I and II)
Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval
A multicenter, prospective, randomized study in a 1:1 ratio, single-blind with double-blind evaluation to evaluate the superiority of physiological ventricular pacing (proposed modality) vs.
- Trial name
- PhysioVP-AF (NCT05367037)
- Testing
- PhysioVP, DDD-VPA
- Where
- Italy
- Volunteers
- 640 people
- Sponsor
- Quovadis Associazione
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
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
Brady-tachy Syndrome, Brady Arrythmia
ALPs Single ChambEr New Device Study
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Brady-tachy Syndrome, Brady Arrythmia, Bradycardia, AV Block
- Trial name
- ASCEND (NCT07469579)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 15 people
- Sponsor
- Cairdac SA
Sinus Node Dysfunction, Atrioventricular Block
Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode
Observational study on long PR interval using the SafeR mode in bradycardia patients.
- Trial name
- PRECISE (NCT02586480)
- Testing
- dual chamber pacemaker with SafeR algorithm
- Where
- 58 sites in France
- Volunteers
- 848 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
Sick Sinus Syndrome
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.
- Trial name
- NCT00161538
- Testing
- Pacing leads to be implanted according randomization., Selection 9000 prevent AF an Diagnose AF
- Where
- 12 sites in Germany
- Volunteers
- 456 people
- Sponsor
- Medtronic BRC
Atrial Fibrillation, Tachycardia, Supraventricular
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of…
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia
- Trial name
- NCT00289289
- Testing
- Intervention Pacing Features
- Where
- 38 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hypertrophic Cardiomyopathy
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement
Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure. A temporary pacing is necessary in patients after cardiac procedures.
- Trial name
- BIVENT (NCT01081093)
- Testing
- additional temporary pacewire
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
BIO|MASTER.CSP Study
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG