Clinical trials: Cardiac Pacemaker, active
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
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
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
Pacing Therapy, Cardiac Pacing
Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction
This study aims to evaluate whether posterosuperior bundle (PSB) pacing reduces the incidence of atrial fibrillation (AF) in patients with sinus node dysfunction (SND) undergoing pacemaker implantation.
- Trial name
- PSB-AF (NCT07645066)
- Testing
- RAA pacing, PSB pacing
- Where
- 10 sites in China
- Volunteers
- 300 people
- Sponsor
- Shanghai Tong Ren Hospital
Permanent Atrial Fibrillation, Preserved Ejection Fraction
Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial
The goal of this clinical trial is to learn whether left bundle branch area pacing, a technique designed to activate the heart's natural electrical conduction system, is better than conventional right ventricular pacing in adults…
- Trial name
- BEAT (NCT07759700)
- Testing
- LBBA pacing, Conventional pacing
- Where
- France
- Volunteers
- 642 people
- Sponsor
- Poitiers University Hospital
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
The PEP-HFpEF study is a prospective, single-center mechanistic study evaluating personalized heart rate pacing (myPACE) in patients with heart failure with preserved ejection fraction (HFpEF) and existing cardiac physiologic…
- Conditions
- Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III, Heart Failure New York Heart Association (NYHA) Class II
- Trial name
- NCT07864558
- Testing
- Individualized myPACE pacemaker programming
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Tufts Medical Center
Heart Failure With Preserved Ejection Fraction
SHort Of Pace - Heart Failure (SHOP-HF)
This study is designed as a multicenter, prospective, controlled, randomized, two-arms, cross-over, two parallel cohorts, efficacy Clinical research with CE-marked medical device .
- Trial name
- NCT06992089
- Testing
- Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
Pain Measurement, Chronic Pain
Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing CIED Implantation Using an AID Support System
Chronic postsurgical pain (CPSP) remains a significant clinical and public health challenge despite major advances in surgical and anesthetic techniques.
- Conditions
- Pain Measurement, Chronic Pain, Cardiac Implantable Electrical Devices, Neuropathic Pain
- Trial name
- PAIN-AID (NCT07322900)
- Volunteers
- 180 people
- Sponsor
- Istanbul University - Cerrahpasa
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
Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment…
- Conditions
- Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation, Right Ventricular Dysfunction
- Trial name
- LvL-PACE (NCT07534917)
- Testing
- Temporary left bundle branch area pacing, Temporary leadless right ventricular pacing
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Heart Failure With Reduced Ejection Fraction
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation.
- Trial name
- RSA-PACE (NCT06384963)
- Testing
- Atrial pacing with respiratory sinus arrhythmia (RSA) variability, Monotonic right atrial overdrive pacing
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 54 people
- Sponsor
- Ceryx Medical Australia
TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder
Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI
Prediction of conduction disorders (CDs) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) is an important and complex process with a significant impact on patient outcomes.
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder, Aortic Stenosis, Permanent Pacemaker Implantation
- Trial name
- NCT07201363
- Testing
- Biomarkers of inflammation and fibrosis in pre-procedural serum blood samples, Transthoracic echocardiography with myocardial deformation analysis and staging according to the extent of cardiac damage related to AS
- Where
- Croatia
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Clinical Hospital Center Rijeka
Intracardiac Thrombus, Intracardiac Mass
AngioVac Aspiration Therapy Registry
As a structured, multinational retrospective registry the AVATAR Registry addresses the following scientific aspects through systematic data collection, centralized quality control, and robust statistical analysis in patients…
- Conditions
- Intracardiac Thrombus, Intracardiac Mass, Intravascular Thrombosis, Vegetation; Heart
- Trial name
- AVATaR (NCT07769320)
- Testing
- Retrospective analysis of assigned treatment
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- Charite University, Berlin, Germany
Complete Heart Block, High Degree Second Degree Atrioventricular Block
Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement (Left Bundle BRAVE)
The purpose of the study is to investigate the superiority of chronic left bundle branch area pacing compared to traditional right ventricular (RV) septal pacing in patients with high-grade conduction disease after transcatheter…
- Conditions
- Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy, Aortic Valve Stenosis
- Trial name
- NCT05541679
- Testing
- Right ventricular septal pacing followed by left bundle branch area pacing, Left bundle branch area pacing followed by right ventricular septal pacing
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- Main Line Health
Heart Failure, Pacemaker
OPTimising a Screening Program to Detect Pacemaker-associated Heart Failure Using Artificial Intelligence
Pacemakers are an effective treatment for slow heart rates which improve symptoms and save lives. However, for some people pacemakers can cause heart failure (HF) because of the unnatural way in which they stimulate heart beats.
- Trial name
- OPT-AI (NCT07372651)
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- University of Leeds
Leadless Pacemaker, Bradycardia
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according…
- Conditions
- Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
- Trial name
- BIO-LivIQ (NCT07118358)
- Testing
- LivIQ Leadless Pacemaker System
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 325 people
- Sponsor
- Biotronik, Inc.
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
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
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
POLish Registry of CArdioneuroablation and CArdioneuromodulation
The multicentre observational study POL-CA involves a wide spectrum of patients with a history of syncopy. The study recruits patients with diagnosed vasovagal syndrome, cardioinhibitory carotid sinus syndrome, symptomatic sinus…
- Conditions
- Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS, Symptomatic Sinus Bradycardia SB or Atrioventricular Block AV, Postural Orthostatic Tachycardia Syndrome POTS
- Trial name
- POL-CA (NCT07196397)
- Testing
- cardioneuroablation, SN sparing hybrid ablation, Cardiac sympathetic denervation
- Where
- Poland
- Volunteers
- 1,000 people
- Sponsor
- SABAMED Medical Center Ltd.
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