Sick Sinus Syndrome Clinical Trial
The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial fibrillation (AF). Two new algorithms (post-AF response and ventricular rate stabilization [VRS]) will be assessed in a combined pathway, compared to a control group. The efficacy of the overall available therapies to prevent AF and its symptoms will then be assessed also.
Due to anti-arrhythmic pharmacological drugs failure to suppress atrial fibrillation (AF),
interest towards preventive pacing treatments is increasing. The importance of this option
in the panoply of the preventive tools is fully justified, only by considering the
insufficiency, the complexity, or the poor reproducibility of the other non-pharmaceutical
approaches.
Preventive pacing therapies rely on their potential effect on different onset modalities
emphasized by previous studies, and more generally by stabilizing atrial tissue when
potential triggers are appearing.
On top of that, cardiac stimulator can deliver these therapies when identifying these
triggers but also can offer incomparable diagnostic tools, in terms of sensitivity,
specificity and continuity in the monitoring.
Four preventive pacing therapies have already been evaluated, the objective of this study is
to show the clinical benefit brought by the new features of the Selection 9000 / Vitatron
T70 DR.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00286858 -
Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
|
||
| Active, not recruiting |
NCT00228241 -
Left Ventricular Function and Remodelling During Permanent Pacing
|
N/A | |
| Completed |
NCT00180557 -
Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
|
Phase 4 | |
| Not yet recruiting |
NCT04149886 -
Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome
|
N/A | |
| Completed |
NCT01609738 -
Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum
|
Phase 1/Phase 2 | |
| Completed |
NCT00785564 -
Imaging Cardiac Electrical Remodeling With Electrocardiogram Imaging (ECGI)
|
||
| Recruiting |
NCT00161551 -
Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)
|
Phase 4 | |
| Recruiting |
NCT05575557 -
Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment
|
N/A | |
| Recruiting |
NCT05186220 -
Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction
|
N/A | |
| Completed |
NCT03843242 -
Evaluation of Ventricular Pacing Suppression Algorithms in Dual Chamber Pacemaker
|
N/A | |
| Terminated |
NCT00475124 -
Virtual Clinic Pacemaker Follow-up
|
Phase 4 | |
| Recruiting |
NCT06288633 -
Cardioneuroablation for Bradyarrhythmia
|
N/A | |
| Terminated |
NCT00236158 -
The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome
|
Phase 2/Phase 3 | |
| Completed |
NCT00000561 -
Mode Selection Trial in Sinus Node Dysfunction (MOST)
|
Phase 3 | |
| Completed |
NCT02154750 -
AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals
|
N/A | |
| Completed |
NCT02198781 -
Right Ventricle (RV) Markers of Future Pacing Induced Ventricular Dysfunction - Pilot
|
||
| Recruiting |
NCT01477138 -
RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome
|
N/A | |
| Terminated |
NCT01074749 -
Optimal Sensing in Atrial Tachyarrhythmia's Study
|
N/A | |
| Completed |
NCT00627328 -
The Atrial High Rate Episodes in Pacemaker Patients
|
N/A | |
| Completed |
NCT00161538 -
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
|
Phase 4 |