Clinical trials: Cardiac Pacemaker, active
Cardiac Pacing, Permanent Pacemaker Implantation
Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation
This single-center, prospective, randomized, controlled clinical trial aims to evaluate whether ultrasound-guided PECS II block, when added to standard local infiltration anesthesia, improves perioperative analgesia in patients…
- Conditions
- Cardiac Pacing, Permanent Pacemaker Implantation, Postoperative Pain
- Trial name
- PACE-PECS (NCT07739407)
- Testing
- Ultrasound-Guided PECS II Block, Standard Local Infiltration Anesthesia
- Volunteers
- 72 people
- Sponsor
- ferdi gülaştı
Heart Failure
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
- Trial name
- TLC-AU (NCT06561932)
- Testing
- WiSE CRT System
- Where
- 4 sites in Australia
- Volunteers
- 40 people
- Sponsor
- EBR Systems, Inc.
Inappropriate Sinus Tachycardia
HEAL-IST IDE Trial
Inappropriate Sinus Tachycardia (IST) is a prevalent and debilitating condition in otherwise healthy younger patients, resulting in significant loss of quality of life, lacking effective treatment options or systematic clinical…
- Trial name
- NCT05280093
- Testing
- AtriCure ISOLATOR Synergy Surgical Ablation System
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 100 people
- Sponsor
- AtriCure, Inc.
Bradycardia
Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices.
- Trial name
- NCT04235491
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
Defibrillators, Implantable, Electrodes, Implanted
Slew Rate As a Predictor for Optimal Lead Fixation
The goal of this observational study is to identify the most reliable electrical parameter measured at the time of implantation that can predict optimal lead fixation and long-term lead performance in patients undergoing…
- Conditions
- Defibrillators, Implantable, Electrodes, Implanted, Pacemaker, Artificial, Predictive Value of Tests
- Trial name
- SLEW REGISTRY (NCT06842940)
- Where
- Italy
- Volunteers
- 516 people
- Sponsor
- Paolo Pastori, MD
Atrial Fibrillation, Heart Failure
RAFT - Pace &Ablate
Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs.
- Conditions
- Atrial Fibrillation, Heart Failure, Pacemaker, Arrhythmia Atrial
- Trial name
- RAFT-P&A RCT (NCT06299514)
- Testing
- Pace and Ablate, Medication
- Where
- 12 sites in Canada
- Volunteers
- 600 people
- Sponsor
- Habib Khan
Left Bundle-Branch Block, Pacemaker DDD
Left Bundle Branch Area Mapping for Conduction System Pacing
This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area.
- Trial name
- NCT05884359
- Testing
- 3D Electroanatomical Mapping (NavX)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and…
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree, Heart Failure
- Trial name
- CIED-CARE (NCT06652750)
- Testing
- Routine Management, 5G Cloud Follow-up
- Where
- 2 sites in China
- Volunteers
- 688 people
- Sponsor
- The Third People's Hospital of Chengdu
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
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
BIO|MASTER.CSP Study
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure with Reduced Ejection Fraction
Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy
The aim of this study proposal is to compare the effectiveness of two distinct pacing modalities for cardiac resynchronization therapy.
- Trial name
- LeCaRT (NCT05365568)
- Testing
- Left Bundle Branch Area Pacing (LBBAP), Biventricular pacing (BiV)
- Where
- 11 sites in Belgium
- Volunteers
- 170 people
- Sponsor
- AZ Sint-Jan AV
Cardiac Amyloidosis, Pacemaker
Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis
In cardiac amyloidosis, the heart muscle becomes thick and stiff, making it difficult to pump enough blood with each beat. The heart also often cannot increase its stroke volume, making patients with cardiac amyloidosis more…
- Trial name
- PACE-ATTR (NCT07413081)
- Testing
- Increasing the pacemaker lower rate, Standard setting
- Where
- 9 sites in Denmark, Sweden
- Volunteers
- 34 people
- Sponsor
- Region Skane
Vasovagal Syncope, AV Block-2Nd Degree-Type 1
Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry
The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency…
- Conditions
- Vasovagal Syncope, AV Block-2Nd Degree-Type 1, Sinus Pause
- Trial name
- CNA-FWRD (NCT06166277)
- Testing
- Ablation procedure
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Rush University Medical Center
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 Amyloidosis, Pacemaker
Elevated Rate Pacing of Cardiac Amyloidosis
This study aims to better quantify the improvements in heart failure symptoms and exercise tolerance before and after the heart rate elevation in a cohort of 10 cardiac amyloidosis patients with preexisting pacemakers.
- Trial name
- NCT07583823
- Testing
- Pacemaker Rate
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Minnesota
Atrial Arrhythmia, Atrial Fibrillation (AF)
Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.
This prospective observational study evaluates the burden of Atrial High-Rate Episodes (AHRE) in patients without a prior history of atrial fibrillation who undergo concurrent Bachmann Bundle Area Pacing (BBAP) and Left Bundle…
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation (AF), Pacemaker Implantation, Left Bundle Branch Pacing
- Trial name
- AHRE-BLAST (NCT07305194)
- Where
- Greece
- Volunteers
- 460 people
- Sponsor
- University Hospital of Patras
Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter
Home Monitor for AA Burden Detection IIT in TWN
Primary Endpoint: Early detection rate in Atrial Arrhythmia (AA) burden Data transmission success rate for overall number of atrial burden collection during the monitoring period Secondary Endpoints: Atrial burden occurrence at…
- Trial name
- FF108 (NCT07572279)
- Where
- 4 sites in Taiwan
- Volunteers
- 30 people
- Sponsor
- National Taiwan University Hospital
Vasovagal Syncope
Assessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates
The investigators will seek to determine the effects of different heart rates on both stroke volume and cardiac output using non-invasive hemodynamic assessments.
- Trial name
- Pacing_SV (NCT03446326)
- Testing
- Pacing
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- University of Calgary
Aortic Stenosis, Right Bundle-Branch Block
Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients…
- Trial name
- TAVI-PACE (NCT05889208)
- Testing
- Prophylactic pacemaker implantation
- Volunteers
- 320 people
- Sponsor
- Aalborg University Hospital
Bradycardia, Syncope
Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.
Background Sinus node dysfunction (SND) and atrioventricular block (AVB) are significant diagnostic and therapeutic problems. The primary method of their treatment is cardiac pacemaker implantation (PM).
- Trial name
- GENTLE-PACE (NCT05896592)
- Testing
- Invasive electrophysiological study, Extracardiac vagal stimulation, Cardioneuroablation
- Where
- 2 sites in Poland
- Volunteers
- 99 people
- Sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland