The Leadless AV Versus DDD Pacing Study: A Randomized Controlled Single-center Trial on Leadless Versus Conventional Cardiac Dual-chamber Pacing
Leadless vs. Conventional Pacemakers: A Trial Comparing Exercise Capacity
Plain English Summary
The Leadless AV Versus DDD Pacing Study is a Phase 4 clinical trial sponsored by Insel Gruppe AG, University Hospital Bern studying Cardiac Pacemaker, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases. This trial tests if a new leadless pacemaker (Micra AV) works as well as traditional pacemakers in improving patients' physical exercise capacity. It is for patients aged 70 and older who need a new pacemaker due to a heart rhythm problem called AV block. Participation involves being randomly assigned to receive either a leadless or a conventional pacemaker, followed by regular check-ups. Alternatives include conventional pacemakers with leads, which are the current standard of care. The trial aims to enroll 100 participants.
Official Summary
Cardiac pacemaker (PM) implantation is the established treatment for relevant bradyarrhythmias. Conventional PMs require 1-3 pacing leads to register the heart's intrinsic activity ("sensing") and to deliver the electrical stimuli to the heart ("pacing"). These leads are responsible for the vast majority of morbidity after implantation and PM failures. Therefore, a leadless PM system (Micra TPS™, Medtronic, United States) has been introduced a few years ago. This system overcomes the limitations of leads, however, the first generation of the Micra TPS™ only allowed sensing and pacing in the right ventricle. More recently, an upgraded version has been introduced and gained market approval (Micra AV, Medtronic, United States). According to published results from several clinical trials, this device allows sensing the atrial activity and, thus, timing the delivery of the ventricular pacing impulse in a physiological manner similar to a conventional dual-chamber PM with two leads. Clinical feasibility and safety for this concept have been established already. However, it is unclear if this translates into a direct clinical benefit for patients in comparison to conventional PM systems. The aim of this trial is to compare the therapeutic efficacy of the Micra AV™ PM and conventional dual-chamber PM systems in patients with intermittent or permanent atrioventricular conduction block and a PM indication according to the latest European guidelines. Thus, patients will be randomized to either a conventional dual-chamber PM implantation or the implantation of a leadless Micra AV™ system. Patients will be stratified for gender (female/male) and a priori estimated physical exercise capacity ("fit"/"unfit"). The primary outcome will be the physical exercise capacity of the patients. The null hypothesis with regards to the primary endpoint is that the leadless pacemaker arm shows an inferior VO2 anaerobic threshold than the conventional pacemaker arm. Hence the alternative hypot
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients 70 years or older who need a new pacemaker for AV block can join. Patients with certain heart conditions like atrial fibrillation, sinus node disease, or low ejection fraction may not be eligible. Individuals who have other device indications (like an ICD) or are on hemodialysis cannot participate. You must be willing and able to follow all study procedures and follow-up appointments. This trial is studying Cardiac Pacemaker, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well patients can exercise after receiving a pacemaker, indicating how it affects their daily physical activity and overall fitness. The specific primary outcome measures are: Exercise capacity (Month 3 post implantation). 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 is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial matters because it compares a newer leadless pacemaker technology against traditional ones to see if it offers a similar or better quality of life, addressing the limitations and potential This research targets Cardiac Pacemaker, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, where improved treatment options are needed.
Investor Insight
This trial investigates a potentially less invasive pacemaker technology, which could expand the market for leadless devices if proven effective and safe, signaling a competitive advancement in cardio This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of both leadless and conventional pacemakers. Understand that you will be randomly assigned to one of the two types of pacemakers. Be prepared for regular follow-up appointments to monitor your pacemaker and health. 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: NONE
- Enrollment: 100 participants
Interventions
- DEVICE: Conventional pacemaker DDD — Implantation of a conventional cardiac pacemaker
- DEVICE: Leadless pacemaker Micra AV — Implantation of a leadless cardiac pacemaker
Primary Outcomes
- Exercise capacity (Month 3 post implantation)
Secondary Outcomes
- Total implantation time (During implantation on day 0)
- Total fluoroscopy time (During implantation on day 0)
- Total fluoroscopy dosage (During implantation on day 0)
- Pacing thresholds (Days 0,1 and months 1,3,12 and 24 post implantation)
- Sensing values (Days 0,1 and months 1,3,12 and 24 post implantation)
Full Eligibility Criteria
Inclusion Criteria: * Patients (≥70y) undergoing a de-novo pacemaker implantation due to intermittent or permanent AV block, qualifying for a conventional or leadless pacemaker * Written informed consent Exclusion Criteria: * Permanent atrial fibrillation or atrial standstill * Evidence of sinus node disease and need for right atrial pacing (not possible with Micra AV) * LVEF \<50% and permanent high-degree or total AVB (requiring CRT/His-Bundle/CSP pacing) * Preoperative E/A ratio \>1.5 in the echocardiography * Any co-existing ICD indications (no leadless ICD systems available) * Hemodialysis * Presence of a mechanical tricuspid valve prosthesis * Unwilling or unable to comply fully with study procedures and follow-up
Trial Locations
- Inselspital, Bern University Hospital, Bern, Switzerland
Frequently Asked Questions
What is clinical trial NCT05498376?
NCT05498376 is a Phase 4 INTERVENTIONAL study titled "The Leadless AV Versus DDD Pacing Study." It is currently recruiting and is sponsored by Insel Gruppe AG, University Hospital Bern. The trial targets enrollment of 100 participants.
What conditions does NCT05498376 study?
This trial investigates treatments for Cardiac Pacemaker, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases. The primary condition under study is Cardiac Pacemaker.
What treatments are being tested in NCT05498376?
The interventions being studied include: Conventional pacemaker DDD (DEVICE), Leadless pacemaker Micra AV (DEVICE). Implantation of a conventional cardiac pacemaker
What does Phase 4 mean for NCT05498376?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT05498376?
This trial is currently "Recruiting." It started on 2022-08-23. The estimated completion date is 2027-12-31.
Who is sponsoring NCT05498376?
NCT05498376 is sponsored by Insel Gruppe AG, University Hospital Bern. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05498376?
The trial aims to enroll 100 participants. The trial is currently recruiting and accepting new participants.
How is NCT05498376 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT05498376?
The primary outcome measures are: Exercise capacity (Month 3 post implantation). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05498376 being conducted?
This trial is being conducted at 1 site, including Bern (Switzerland).
Where can I find official information about NCT05498376?
The official record for NCT05498376 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05498376. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05498376 testing in simple terms?
This trial tests if a new leadless pacemaker (Micra AV) works as well as traditional pacemakers in improving patients' physical exercise capacity. It is for patients aged 70 and older who need a new pacemaker due to a heart rhythm problem called AV block.
Why is this trial significant?
This trial matters because it compares a newer leadless pacemaker technology against traditional ones to see if it offers a similar or better quality of life, addressing the limitations and potential
What are the potential risks of participating in NCT05498376?
The main risks are related to the pacemaker implantation procedure itself, such as bleeding or infection. Potential side effects specific to pacemakers can include discomfort, device malfunction, or issues with the pacing leads (for conventional pacemakers). For leadless pacemakers, risks include dislodgement or difficulty in removal. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05498376?
Ask your doctor about the potential benefits and risks of both leadless and conventional pacemakers. Understand that you will be randomly assigned to one of the two types of pacemakers. Be prepared for regular follow-up appointments to monitor your pacemaker and health. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05498376 signal from an investment perspective?
This trial investigates a potentially less invasive pacemaker technology, which could expand the market for leadless devices if proven effective and safe, signaling a competitive advancement in cardio This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves being randomly assigned to receive either a leadless or a conventional pacemaker, followed by regular check-ups. 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
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.