Clinical trials: Cardiac Pacemaker Malfunction, active
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
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
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
Cardiac Pacemaker Malfunction, ICD Malfunction
Perioperative Management Evaluation in Patients With CIED
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
- Conditions
- Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication
- Trial name
- EVINCE (NCT04331249)
- Testing
- surgery or catheter based cardiac procedure (catheter ablation)
- Where
- 2 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Klinikum-Fuerth
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
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
Bradyarrhythmias, Heart Failure
Clinical Study of Impact of Different Pacing Site in Patients
At present, cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients.
- Conditions
- Bradyarrhythmias, Heart Failure, Pacemaker
- Trial name
- NCT04931550
- Testing
- Pacemaker implantation
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Device Related Infection, Device Malfunction
Project My Heart Your Heart: Pacemaker Reuse
Lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in Low and Middle Income Countries (LMIC).
- Conditions
- Device Related Infection, Device Malfunction, Bradycardia
- Trial name
- MHYH (NCT04016870)
- Testing
- Reconditioned Pacemaker, New Pacemaker
- Where
- 8 sites in Kenya, Mexico and 5 more
- Volunteers
- 370 people
- Sponsor
- University of Michigan
Pacemaker DDD, Heart Block
Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF).
- Trial name
- NCT05015660
- Testing
- Left bundle branch pacing lead, Right ventricular active fixation lead
- Where
- Canada
- Volunteers
- 1,300 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Heart Failure
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.
- Trial name
- DANLOGIC-HF (NCT06099158)
- Testing
- HeartLogic
- Where
- 5 sites in Denmark
- Volunteers
- 1,428 people
- Sponsor
- Tor Biering-Sørensen
Atrial Fibrillation (AF), Heart Failure - NYHA II - IV
Cardiovascular Performance and Exercise Response in Patients With Persistent or Permanent Atrial Fibrillation and Heart Failure Pre and Post Cardioversion or Pace and Ablate
Heart Failure (HF) and Atrial Fibrillation (AF) are two conditions that commonly occur together. Clinical guidelines consider a resting heart rate of 100-110 beats per minute (bpm) acceptable for patients with HF and AF while 72…
- Conditions
- Atrial Fibrillation (AF), Heart Failure - NYHA II - IV, Pacemaker, Cardioversion
- Trial name
- CPEX-CPA (NCT07205679)
- Volunteers
- 40 people
- Sponsor
- Habib Khan
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 338 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
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
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
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.
Cardiovascular Diseases, Arrhythmias, Cardiac
Multicenter Evaluation of Patients Using LATITUDE Monitoring System
The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.
- Conditions
- Cardiovascular Diseases, Arrhythmias, Cardiac, Heart Failure, Sudden Cardiac Death
- Trial name
- Multitude (NCT06311149)
- Where
- 3 sites in Italy
- Volunteers
- 20,000 people
- Sponsor
- University Hospital of Ferrara
Atrial Fibrillation (AF), Pacemaker Therapy
Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF
This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate…
- Conditions
- Atrial Fibrillation (AF), Pacemaker Therapy, Atrioventricular Block, Preserved Ejection Fraction
- Trial name
- LBBP-AHRE (NCT07250529)
- Testing
- Right Ventricular Pacing, Left Bundle Branch Pacing
- Where
- Greece
- Volunteers
- 244 people
- Sponsor
- University Hospital of Patras
Cardiac Resynchronisation Therapy (CRT), Heart Failure
A Study Testing a New Heart Scan Method to Improve Pacemaker Treatment for Heart Failure
Cardiac resynchronization therapy (CRT) is a device treatment for patients with heart failure which cannot be managed by medications alone. CRT can help the heart contract more efficiently and improve the pumping function.
- Trial name
- EFFECT-CRT (NCT07084467)
- Testing
- EF1 guided CRT optimisation, Standard of Care (SOC)
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- King's College London