Clinical trials: Sick Sinus Node Syndrome
Sinus Node Dysfunction
Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only.
- Trial name
- SANOK (NCT05196126)
- Testing
- Permament pacemaker implantation, Cardioneuroablation
- Where
- 4 sites in Poland
- Volunteers
- 60 people
- Sponsor
- Stec, Sebastian, MD, PhD, FESC
Cardiac Disease, Syncope
Second Study on Cardio-neuromodulation in Humans
Different approaches to cardio-neuroablation (CNA) to treat neurally mediated syncope, sinus node dysfunction, and functional atrioventricular block have been published.
- Conditions
- Cardiac Disease, Syncope, Syncope, Vasovagal, Sick Sinus Syndrome
- Trial name
- CardNMH2 (NCT02954666)
- Testing
- radio-frequency ablation
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Imelda Hospital, Bonheiden
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Atrioventricular Block, Second and Third Degree
Predicting Severe Cardiac Arrhythmias in the Perioperative Period Using AI-ECG
During the preoperative examination, in addition to the standard examination recommended before high-risk cardiac surgeries, a digital single-lead ECG is recorded using portable CardioQUARK devices.
- Conditions
- Atrial Fibrillation, Atrioventricular Block, Second and Third Degree, Sinus Node Dysfunction, Ventricular Tachycardia (VT)
- Trial name
- NCT07348991
- Testing
- digital single-channel ECG recording
- Volunteers
- 300 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Sick Sinus Syndrome
Atrial Synchrony Evaluation of Bachmann Bundle Pacing in Sick Sinus Syndrome
This is a prospective, randomized study to compare the effects of Bachmann bundle pacing (BBP) versus conventional right atrial appendage (RAA) pacing on atrial electromechanical synchrony in patients with sick sinus syndrome…
- Trial name
- NCT07055035
- Testing
- Bachmann Bundle Pacing, Right Atrial Appendage Pacing
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Shiyan City Renmin Hospital
Sick Sinus Node Syndrome
Model 20105 Lead Study
The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.
- Trial name
- NCT02301429
- Testing
- Model 20105
- Where
- 4 sites in Canada, Netherlands and 2 more
- Volunteers
- 16 people
- Sponsor
- Medtronic BRC
Blood Pressure
Long-term Atrial Pacing and Central Blood Pressure
This is a randomized controlled single-centre clinical trial with a cross-over design to compare non-invasively evaluated central blood pressure and related parametres in sick sinus syndrome patients with hypertension who are…
- Trial name
- NCT04309175
- Testing
- base rate programming of a permanent cardiac pacemaker
- Volunteers
- 58 people
- Sponsor
- Tartu University Hospital
Cardiac Pacemaker, Cardiac Rhythm Disorder
LEAP 2 Chronic EFS
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT07287423
- Testing
- AVEIR CSP Leadless Pacemaker System
- Where
- Czechia
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
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.
Heart Failure With Reduced Ejection Fraction, Atrial Fibrillation, Persistent
Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment
With the aging of society, the use of cardiac pacing in patients with irreversible bradycardia is increasingly widespread. As early as the 1950s, right ventricular pacing (RVP) began to be used in patients with atrioventricular…
- Conditions
- Heart Failure With Reduced Ejection Fraction, Atrial Fibrillation, Persistent, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- NCT05575557
- Testing
- Right heart catheterization
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shanghai 10th People's Hospital
Sick Sinus Syndrome, Hypertension
Effect of Paced HR on Central BP
Central (aortic) blood pressure predicts heart, brain and kidney complications more reliably than the usual peripherally measured blood pressure.
- Trial name
- NCT07078487
- Testing
- Pacemaker and defibrillator
- Where
- Estonia
- Volunteers
- 22 people
- Sponsor
- University of Tartu
Atrial Fibrillation, Sick Sinus Syndrome
PACE-AF: Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation
PACE-AF is a prospective, observational patient registry designed to evaluate the impact of pacemaker algorithms on atrial fibrillation (AF) incidence, progression, and clinical outcomes in patients implanted with dual-chamber…
- Conditions
- Atrial Fibrillation, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- PACE-AF (NCT07279207)
- Where
- Russia
- Volunteers
- 500 people
- Sponsor
- Ilya Lukin
Arrhythmias, Cardiac
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Biorepository of blood and or tissue samples from patients presenting with cardiac arrhythmia syndromes.
- Trial name
- NCT00921986
- Where
- United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Sick Sinus Syndrome, AV-Block
Left Ventricular Function and Remodelling During Permanent Pacing
1. Background - Pacemaker treatment gives asynchronous activation of the heart that often results in decreased heart function and clinical heart failure.
- Trial name
- NCT00228241
- Testing
- AAI vs. DDD vs. BIV pacing in different patients groups
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Aarhus University Hospital Skejby
Congenital Heart Disease, Bradycardia Sinus
Specialized Pacing for Patients With Congenital Heart Disease
The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing…
- Trial name
- NCT03361189
- Testing
- Closed loop stimulation, Standard rate response
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, Los Angeles
Bradycardia, Syncope
Cardioneuroablation for Bradyarrhythmia
This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker…
- Conditions
- Bradycardia, Syncope, Sick Sinus Syndrome
- Trial name
- CARDIOBOOST (NCT06288633)
- Testing
- Ganglionated plexi ablation, Electrophysiological study
- Where
- Russia
- Volunteers
- 106 people
- Sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sick Sinus Syndrome
Right Ventricle (RV) Markers of Future Pacing Induced Ventricular Dysfunction - Pilot
This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population who are clinically indicated to receive a pacemaker.
- Trial name
- NCT02198781
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Mid and South Essex NHS Foundation Trust
Sinus-node Dysfunction
Right Ventricular Outflow Tract Study
This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path…
- Trial name
- RVOTCARE (NCT01294839)
- Testing
- Right ventricular lead location
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines
AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of…
- Trial name
- NCT06782152
- Volunteers
- 1,698 people
- Sponsor
- King Fahad Armed Forces Hospital
Atrial Fibrillation, Bradycardia
Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class
This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be…
- Conditions
- Atrial Fibrillation, Bradycardia, Heart Block, Sick Sinus Syndrome
- Trial name
- NCT00292539
- Testing
- Any pacemaker with right ventricular pacing option
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- Guidant Corporation