Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study
New Pacemaker Technique Trial for Heart Health
Plain English Summary
Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy is a Not Applicable clinical trial sponsored by Hospital Clinic of Barcelona studying Conduction System Pacing, Conventional Ventricular Pacing. This study compares a new way of implanting pacemakers (conduction system pacing) with the standard method to see if it prevents heart muscle damage. It is for adults (18+) with a slow heart rhythm (AV block) who need a pacemaker and have good heart pumping function. Participants will have a pacemaker implanted and will attend regular follow-up appointments at the study center. The standard treatment for a slow heart rhythm is a pacemaker, but this trial explores a potentially better placement technique. The trial aims to enroll 200 participants.
Official Summary
The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older who need a pacemaker due to a slow heart rhythm. Patients with a heart pumping function (EF) greater than 50%. Individuals who can understand and sign the study consent form. People who do not have severe other health problems or a life expectancy less than 1 year. This trial is studying Conduction System Pacing, Conventional Ventricular Pacing, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if the new pacemaker placement reduces the occurrence of heart muscle disease over 12 months compared to the standard method. The specific primary outcome measures are: Compare the incidence of pacemaker-induced heart disease (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to find a better way to implant pacemakers that may prevent long-term heart muscle weakening, addressing a gap in current pacemaker technology. This research targets Conduction System Pacing, Conventional Ventricular Pacing, where improved treatment options are needed.
Investor Insight
This trial focuses on optimizing pacemaker technology, a significant market, with potential to improve patient outcomes and reduce future healthcare costs associated with pacemaker-induced heart probl
Is This Trial Right for Me?
Ask your doctor if this new pacemaker technique is suitable for your specific heart condition. Participation involves a pacemaker implantation procedure and regular visits to the hospital for check-ups over several years. You will need to be able to travel to the study center for all scheduled appointments. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 200 participants
Interventions
- DEVICE: Pacemaker implantation and conventional cardiac pacing — Patients will have the pacemaker implanted in the electrophysiology laboratory. Electrode will be implanted (in the apical or septal portion) according to the criteria of the implanting physician.
- DEVICE: Conduction system pacing implant — Right ventricular lead was placed to get his bundle or left bundle branch.
Primary Outcomes
- Compare the incidence of pacemaker-induced heart disease (12 months)
Secondary Outcomes
- Change in end-systolic volume. (12 Months)
- Correction of septal flash. (12 Months)
- Incidence of new onset of atrial fibrillation. (12 Months)
- Hospitalization due to heart failure. (12 Months)
- New York Heart Association functional classification. (12 Months)
Full Eligibility Criteria
Inclusion Criteria: * The patient must be ≥ 18 years of age. * The patient must indicate their acceptance to participate in the study by signing an informed consent document. * Patients with EF\> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines. Exclusion Criteria: * Inability to understand and sign the informed consent. * Patients with severe comorbidities and life expectancy \<1 year. * Patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life. * Patients who cannot come to our center to carry out the follow-up of the study.
Trial Locations
- Hospital Clinic of Barcelona, Barcelona, Spain
Frequently Asked Questions
What is clinical trial NCT05214365?
NCT05214365 is a Not Applicable INTERVENTIONAL study titled "Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy." It is currently recruiting and is sponsored by Hospital Clinic of Barcelona. The trial targets enrollment of 200 participants.
What conditions does NCT05214365 study?
This trial investigates treatments for Conduction System Pacing, Conventional Ventricular Pacing. The primary condition under study is Conduction System Pacing.
What treatments are being tested in NCT05214365?
The interventions being studied include: Pacemaker implantation and conventional cardiac pacing (DEVICE), Conduction system pacing implant (DEVICE). Patients will have the pacemaker implanted in the electrophysiology laboratory. Electrode will be implanted (in the apical or septal portion) according to the criteria of the implanting physician.
What does Not Applicable mean for NCT05214365?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05214365?
This trial is currently "Recruiting." It started on 2022-02-01. The estimated completion date is 2026-09-01.
Who is sponsoring NCT05214365?
NCT05214365 is sponsored by Hospital Clinic of Barcelona. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05214365?
The trial aims to enroll 200 participants. The trial is currently recruiting and accepting new participants.
How is NCT05214365 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05214365?
The primary outcome measures are: Compare the incidence of pacemaker-induced heart disease (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05214365 being conducted?
This trial is being conducted at 1 site, including Barcelona (Spain).
Where can I find official information about NCT05214365?
The official record for NCT05214365 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05214365. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05214365 testing in simple terms?
This study compares a new way of implanting pacemakers (conduction system pacing) with the standard method to see if it prevents heart muscle damage. It is for adults (18+) with a slow heart rhythm (AV block) who need a pacemaker and have good heart pumping function.
Why is this trial significant?
This trial aims to find a better way to implant pacemakers that may prevent long-term heart muscle weakening, addressing a gap in current pacemaker technology.
What are the potential risks of participating in NCT05214365?
As with any surgery, there are risks of bleeding, infection, or damage to blood vessels during pacemaker implantation. Potential side effects specific to pacemakers include discomfort at the implant site, or the device not working as expected. The new technique might have its own specific risks that are being studied. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05214365?
Ask your doctor if this new pacemaker technique is suitable for your specific heart condition. Participation involves a pacemaker implantation procedure and regular visits to the hospital for check-ups over several years. You will need to be able to travel to the study center for all scheduled appointments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05214365 signal from an investment perspective?
This trial focuses on optimizing pacemaker technology, a significant market, with potential to improve patient outcomes and reduce future healthcare costs associated with pacemaker-induced heart probl This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have a pacemaker implanted and will attend regular follow-up appointments at the study center. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Conduction System Pacing Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.