Clinical trials: Sinus Node Dysfunction
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
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.
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
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
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
Bradycardia, Sinus Node Dysfunction
LBBAP Data Collection Registry
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT05887323
- Testing
- Implantation of the Tendril 2088 lead in the LBBA
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 221 people
- Sponsor
- Abbott Medical Devices
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
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 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
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 Node Dysfunction, Sick Sinus Syndrome
Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction
Endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (VV), functional atrioventricular block (AVB) and sinus node dysfunction (SND) with a…
- Trial name
- DINERVAPACE (NCT05186220)
- Testing
- Cardioneuroablation, Permanent dual chamber pacemaker implantation
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Hospital Clinico Universitario de Santiago
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
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
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
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-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
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
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
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
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