Clinical trials: Sinus Node Disease
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
Sinus Bradycardia, Sinus Node Disease
Real Life Automatic Atrial Capture Device Control
The main objective of this study is to verify the effectiveness of the new ACAP ® Confirm algorithm in the automatic management of atrial capture.
- Conditions
- Sinus Bradycardia, Sinus Node Disease, Atrio-ventricular Block, Heart Failure
- Trial name
- NCT02400983
- Testing
- Pacemaker, ICD
- Volunteers
- 318 people
- Sponsor
- Maria Vittoria Hospital
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
Pacing Therapy, Cardiac Pacing
Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction
This study aims to evaluate whether posterosuperior bundle (PSB) pacing reduces the incidence of atrial fibrillation (AF) in patients with sinus node dysfunction (SND) undergoing pacemaker implantation.
- Trial name
- PSB-AF (NCT07645066)
- Testing
- RAA pacing, PSB pacing
- Where
- 10 sites in China
- Volunteers
- 300 people
- Sponsor
- Shanghai Tong Ren Hospital
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 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
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
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
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
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
Bradyarrhythmias, AV Block Complete
Belgo-Luxembourg Leadless PM Registry
This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott.
- Conditions
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1, Pacemaker
- Trial name
- BELLA (NCT07879716)
- Testing
- CT scan heart, 24 hour ambulatory ECG monitoring
- Where
- 9 sites in Belgium, Luxembourg
- Volunteers
- 190 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Sinus Node Disease, Atrial Fibrillation
Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.
Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death.
- Trial name
- DANPACEII (NCT02034526)
- Testing
- DDDR-60, DDD-40
- Where
- Denmark
- Volunteers
- 540 people
- Sponsor
- Aarhus University Hospital
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
Squamous Cell Carcinoma of Head and Neck (SCCHN), Metastatic Colorectal Cancer
Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy
This was an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the orally administered c-MET inhibitor INC280 in combination with cetuximab.
- Trial name
- NCT02205398
- Testing
- INC280, cetuximab
- Where
- 15 sites in United States, Belgium and 5 more
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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
Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome
Inappropriate Sinus Tachycardia Registry
The primary objective of this registry is to capture real-world safety and performance data on AtriCure devices used to ablate cardiac tissue when treating Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome…
- Trial name
- NCT05107635
- Testing
- AtriCure Commercially Available Devices
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 500 people
- Sponsor
- AtriCure, Inc.
Sinus Node Dysfunction, Atrial Fibrillation
Atrial Fibrillation With Sinus Node Dysfunction: Intensive Device Follow-up
The study will try to access the efficacy of atrial pacing, medication and radiofrequency ablation in treating patients with paroxysmal atrial fibrillation and sinus node dysfunction; to identify the response to these treatments…
- Trial name
- SAFE PAF-SND (NCT03607123)
- Testing
- programing of pacemaker, AF ablation, Anti arryhthmic drugs
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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.