Clinical trials: Sinus Node Disease.
Bradycardia
Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction
The study is a prospective, randomized controlled study in hypertensive patients with a bradycardia indications for pacing therapy and a plan to receive dual-chamber pacemaker.
- Trial name
- NCT07589452
- Testing
- Personalized lower rate pacing, Standard lower rate pacing
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
AV Block
Danish Randomized Trial on Leadless vs Transvenous Pacing
The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block.
- Trial name
- DANVERS (NCT05856799)
- Testing
- Leadless Micra AV Transcatheter Pacing System, Transvenous Azure XT DR dual chamber pacemaker
- Where
- 2 sites in Denmark
- Volunteers
- 80 people
- Sponsor
- University of Aarhus
Cardiac Pacemaker, Arrythmia
Aveir VR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05270499
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 3,427 people
- Sponsor
- Abbott Medical Devices
Aortic Blood Pressure
The Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
This study is divided into two parts: The first part evaluates the acute effect of non-pharmacological heart rate change on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac…
- Trial name
- NCT03245996
- Testing
- AAI 40 bpm, AAI 60 bpm, AAI 90 bpm
- Volunteers
- 27 people
- Sponsor
- Tartu University 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 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 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
Testis Cancer, Germ Cell Tumor
Role of Axumin PET Scan in Germ Cell Tumor
Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.
- Conditions
- Testis Cancer, Germ Cell Tumor, Testicular Cancer, Germ Cell Tumor of Testis
- Trial name
- TESTPET (NCT03426865)
- Testing
- Axumin PET scan
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Texas Southwestern Medical Center
Sinus Node Dysfunction, Bradycardia-Tachycardia Syndrome
Spontaneous Atrio Ventricular Conduction Preservation
In case of sinus node dysfunction, it is often necessary to choose the safer option provided by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode.
- Conditions
- Sinus Node Dysfunction, Bradycardia-Tachycardia Syndrome, Paroxysmal Atrioventricular Block
- Trial name
- SAVER (NCT00655213)
- Testing
- Symphony D 2450, Symphony DR 2550
- Where
- 67 sites in Belgium, France and 3 more
- Volunteers
- 622 people
- Sponsor
- LivaNova
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
Congenital Heart Disease
Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation
This prospective randomized controlled trial aims to examine the effect of subcostal transverse abdominis plane block on the postoperative pain and opioid consumption in patients (12y≤ age) who will undergo epigastric cardiac…
- Trial name
- NCT04570878
- Testing
- SC TAP, Control
- Where
- South Korea
- Volunteers
- 22 people
- Sponsor
- Seoul National University Hospital
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
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
To Pace or Not to Pace in Sinus Node Disease
Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing.
- Trial name
- OPTIMIST (NCT02485093)
- Testing
- Septal ventricular pacing, VIP
- Where
- France
- Volunteers
- 215 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation
This is a randomized, parallel, single-blinded multi-center study. The objective is to compare the long term clinical outcomes among the site of atrial pacing and to compare the long term effect of the atrial fibrillation (AF)…
- Trial name
- SAFE (NCT00419640)
- Testing
- Pacemaker implantation with RA lead in LAS position, Pacemaker implantation with RA lead in RAA position
- Where
- Hong Kong
- Volunteers
- 385 people
- Sponsor
- Abbott Medical Devices
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
Head and Neck Carcinoma, Head and Neck Carcinoma of Unknown Primary
Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study
This clinical trial studies how well intensity modulated proton therapy (IMPT) or intensity modulated X-ray (radiation) therapy (IMRT) works after surgery in treating patients with head and neck cancer.
- Conditions
- Head and Neck Carcinoma, Head and Neck Carcinoma of Unknown Primary, Hypopharyngeal Carcinoma, Laryngeal Carcinoma
- Trial name
- NCT05075980
- Testing
- Cisplatin, Intensity-Modulated Proton Therapy, Quality-of-Life Assessment
- Where
- 9 sites in United States
- Volunteers
- 174 people
- Sponsor
- Mayo Clinic
Squamous Cell Carcinoma of the Head and Neck
Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck
This study involves another course of radiation (called re-irradiation) to the participant's tumor. The type of radiation is called stereotactic body radiation therapy (SBRT).
- Trial name
- NCT02158234
- Testing
- Cisplatin, Stereotactic Body Radiation Therapy (SBRT)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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