Clinical trials: Pacemakers, active
Quality of Life (QOL) and Impact of Stress
Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation
The project "Investigating Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation" aims to investigate the relationship between stress and the postoperative healing process…
- Trial name
- NCT07343466
- Testing
- Survey using a questionnaire.
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- University Hospital, Essen
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
Device:MRI
Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators
Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns.
- Trial name
- NCT02888353
- Testing
- Device: MRI
- Where
- United States
- Volunteers
- 4,500 people
- Sponsor
- Johns Hopkins University
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
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
Hypertension, Hypertension, Systolic
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure…
- Conditions
- Hypertension, Hypertension, Systolic, Hypertension, Essential
- Trial name
- BACKBEAT (NCT06059638)
- Testing
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated, Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
- Where
- 131 sites in United States, Australia and 13 more
- Volunteers
- 316 people
- Sponsor
- Orchestra BioMed, Inc
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
Atrioventricular Synchrony by the Micra AV
French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV
Transvenous cardiac pacemakers have pitfalls due to lead- and device pocket-related complications. Leadless pacemakers were developed and introduced into clinical practice to overcome the weaknesses of traditional transvenous…
- Trial name
- AV-CESAR (NCT05953558)
- Testing
- Patients implanted with Micra AV
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Paris Sudden Death Expertise Center
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
Leadless Pacemaker
Aveir Leadless Pacemaker Japan PMS
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing.
- Trial name
- NCT07106788
- Testing
- Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients, Upgrades
- Where
- 14 sites in Japan
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices