Pacing Advancements With Cost and Experience VALuation for Unified Patient-Led Clinical Evidence - the PACEVALUE Study
PACEVALUE study: Predicting heart problems after pacemaker/ICD implantation
Plain English Summary
PACEVALUE: Development of a Risk Score to Predict Pacing-Induced Cardiomyopathy in Patients Undergoing Pacemaker or ICD Implantation and Evaluation of Patient Outcomes and Cost-Effectiveness Across Different Healthcare Systems is a Not Applicable clinical trial sponsored by Insel Gruppe AG, University Hospital Bern studying Cardiomyopathy, Secondary, Arrhythmias, Cardiac, Heart Failure, Pacing Induced Cardiomyopathy, Conduction System Pacing. This study tests a new way to predict if patients might develop heart muscle weakness (pacing-induced cardiomyopathy) after getting a pacemaker or ICD. It's for adults who are about to receive a pacemaker, ICD, or CRT device. Participation involves regular check-ups and providing information about your health and device for at least two years. Alternatives include standard device implantation without this specific risk prediction. The trial aims to enroll 4500 participants.
Official Summary
The PACEVALUE study is a large, international observational study aiming to improve the treatment of patients receiving cardiac implantable electronic devices (CIEDs) such as pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. While these devices are vital for managing heart rhythm disorders and heart failure, chronic right ventricular pacing can sometimes cause a condition called pacing-induced cardiomyopathy (PICM), where the left side of the heart weakens over time, leading to increased hospitalizations and higher mortality. The main goal of the study is to develop and validate a risk prediction model using routine clinical and device data to identify patients at highest risk of PICM before device implantation. By stratifying patients according to this risk score, the study aims to guide personalized pacing strategies, including conduction system pacing (CSP) and CRT options, to improve outcomes and reduce complications. The study will recruit approximately 4,500 patients across multiple centers in Europe and Australia, with planned future inclusion of sites in the UK. Participants will be followed for a minimum of two years, with data collection including heart function imaging, device data, clinical outcomes, patient-reported outcomes (PROMs/PREMs), and healthcare costs. This observational study will also compare clinical practices and cost-effectiveness of different pacing strategies across diverse healthcare systems, aiming to inform evidence-based, patient-centered, and economically efficient device therapy decisions. The findings will lay the groundwork for future registry-based randomized controlled trials to further optimize pacing treatments.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older who are getting a pacemaker, ICD, or CRT device. Patients must be able to understand and give consent to participate. Individuals with severe cognitive impairment may not be able to join unless they have a legal representative. The study focuses on patients undergoing device implantation. This trial is studying Cardiomyopathy, Secondary, Arrhythmias, Cardiac, Heart Failure, Pacing Induced Cardiomyopathy, Conduction System Pacing, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see how many patients develop a weakening of their heart's main pumping chamber (left ventricle) after getting a device, which could lead to heart failure. The specific primary outcome measures are: Number of participants developing PICM, defined as an absolute decline in left ventricular ejection fraction (LVEF) of ≥10 percentage points to ≤50% during long-term follow-up after CIED implantation (up to 2 years after device 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 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 matters because it aims to prevent a specific type of heart muscle weakening that can occur after pacemaker or ICD implantation, potentially improving long-term heart health for many patien This research targets Cardiomyopathy, Secondary, Arrhythmias, Cardiac, Heart Failure, Pacing Induced Cardiomyopathy, Conduction System Pacing, where improved treatment options are needed.
Investor Insight
This observational study aims to create a tool to better select patients for specific pacing strategies, potentially reducing complications and healthcare costs, which could be valuable for device man The large enrollment target of 4500 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about your individual risk for pacing-induced cardiomyopathy and how this study might help personalize your treatment. You will have regular follow-up appointments and may need to complete questionnaires about your health and quality of life. Your device data and heart function will be monitored over at least two years. 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: OBSERVATIONAL
- Enrollment: 4,500 participants
Primary Outcomes
- Number of participants developing PICM, defined as an absolute decline in left ventricular ejection fraction (LVEF) of ≥10 percentage points to ≤50% during long-term follow-up after CIED implantation (up to 2 years after device implantation)
Secondary Outcomes
- Number of participants who died from any cause on follow-up (up to 5 years after device implantation)
- Number of participants hospitalized for heart failure on follow-up (up to 5 years after device implantation)
- Number of participants hospitalized for other cardiovascular events (excluding heart failure) on follow-up (up to 5 years after device implantation)
- Number of participants hospitalized for non-cardiovascular reasons on follow-up (up to 5 years after device implantation)
- Number of participants undergoing upgrade to CRT on follow-up (up to 5 years after device implantation)
Full Eligibility Criteria
Inclusion Criteria: * Signed informed consent prior to enrollment * Age ≥18 years * Undergoing a CIED implantation (permanent pacemaker, ICD, or CRT) * Willing and able to participate in long-term follow-up * Sufficient language comprehension (or support) to provide informed consent and complete PROMs/PREMs. Exclusion Criteria: * Severe cognitive impairment without a legal representative
Trial Locations
- Inselspital, University Hospital Bern, Bern, Switzerland
Frequently Asked Questions
What is clinical trial NCT07276139?
NCT07276139 is a Not Applicable OBSERVATIONAL study titled "PACEVALUE: Development of a Risk Score to Predict Pacing-Induced Cardiomyopathy in Patients Undergoing Pacemaker or ICD Implantation and Evaluation of Patient Outcomes and Cost-Effectiveness Across Different Healthcare Systems." It is currently active, not recruiting and is sponsored by Insel Gruppe AG, University Hospital Bern. The trial targets enrollment of 4500 participants.
What conditions does NCT07276139 study?
This trial investigates treatments for Cardiomyopathy, Secondary, Arrhythmias, Cardiac, Heart Failure, Pacing Induced Cardiomyopathy, Conduction System Pacing. The primary condition under study is Cardiomyopathy, Secondary.
What does Not Applicable mean for NCT07276139?
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 NCT07276139?
This trial is currently "Active, Not Recruiting." It started on 2026-01-01. The estimated completion date is 2031-01-01.
Who is sponsoring NCT07276139?
NCT07276139 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 NCT07276139?
The trial aims to enroll 4500 participants. The trial status is active, not recruiting.
How is NCT07276139 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07276139?
The primary outcome measures are: Number of participants developing PICM, defined as an absolute decline in left ventricular ejection fraction (LVEF) of ≥10 percentage points to ≤50% during long-term follow-up after CIED implantation (up to 2 years after device implantation). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07276139 being conducted?
This trial is being conducted at 1 site, including Bern (Switzerland).
Where can I find official information about NCT07276139?
The official record for NCT07276139 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07276139. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07276139 testing in simple terms?
This study tests a new way to predict if patients might develop heart muscle weakness (pacing-induced cardiomyopathy) after getting a pacemaker or ICD. It's for adults who are about to receive a pacemaker, ICD, or CRT device.
Why is this trial significant?
This trial matters because it aims to prevent a specific type of heart muscle weakening that can occur after pacemaker or ICD implantation, potentially improving long-term heart health for many patien
What are the potential risks of participating in NCT07276139?
The main risk is the potential development of pacing-induced cardiomyopathy, which can weaken the heart muscle over time. Other potential risks are related to the implantation of the device itself, such as infection or bleeding. Side effects could include fatigue, shortness of breath, or swelling, which are symptoms of heart failure. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07276139?
Ask your doctor about your individual risk for pacing-induced cardiomyopathy and how this study might help personalize your treatment. You will have regular follow-up appointments and may need to complete questionnaires about your health and quality of life. Your device data and heart function will be monitored over at least two years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07276139 signal from an investment perspective?
This observational study aims to create a tool to better select patients for specific pacing strategies, potentially reducing complications and healthcare costs, which could be valuable for device man This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves regular check-ups and providing information about your health and device for at least two years. 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 Cardiomyopathy, Secondary Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.