Cardiomyopathy, SecondaryPACEVALUENCT07276139
Pacing Advancements With Cost and Experience VALuation for Unified Patient-Led Clinical Evidence - the PACEVALUE Study
An observational study of Cardiomyopathy, Secondary and Arrhythmias, Cardiac, run by Insel Gruppe AG, University Hospital Bern at 13 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Secondary, Arrhythmias, Cardiac, Heart Failure
- How many people
- 4,500 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 1 Jan 2026to 1 Jan 2031
- How long will I take part?
- 120 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adults undergoing a cardiac implantable electronic device (CIED) procedure for standard clinical indications, included in two arms. In the prospective arm, consecutive patients at a participating center are enrolled at the time of the procedure. In the retrospective arm, centers include all consecutive patients who underwent a CIED procedure from a center-specific start date up to the date of data extraction, using data already recorded during clinical care. Participants are drawn from centers in Switzerland, Germany, Poland, Croatia, Bulgaria, Cyprus, and Australia, with planned activation of sites in the UK. The population includes patients receiving pacemakers, ICDs, or CRT devices; patients with existing CRT at baseline serve as a comparator. Both arms use the same case report form and the same endpoint definitions. Enrollment reflects diverse healthcare settings and demographics.
Who may be able to join
- Age ≥18 years at the time of the CIED procedure
- Undergoing, or having undergone, a CIED procedure (permanent pacemaker, ICD, or CRT)
- A lawful basis for inclusion: signed informed consent prior to enrollment in the prospective arm, or a lawful basis for the further use of health-related personal data in the retrospective arm
- Prospective arm only: willing and able to participate in long-term follow-up
- Prospective arm only: sufficient language comprehension (or support) to provide informed consent and complete PROMs/PREMs
Who cannot join
- Prospective arm only: severe cognitive impairment without a legal representative
- A documented objection to the use of health-related data for research
Trial locations and contacts
13 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 7 countries
Poland4 sites, 4 recruiting
- Not yet recruiting
Clinical Provincial Hospital No. 2
Rzeszów
- Not yet recruiting
National Institute of Cardiology
Warsaw
- Not yet recruiting
4th Military Clinical Hospital
Wroclaw
- Not yet recruiting
Medical University of Silesia
Zabrze
Switzerland3 sites, 3 recruiting
- Not yet recruiting
Kantonsspital Baden
Baden
- Recruiting
Inselspital, University Hospital Bern
Bern, 3010
- Not yet recruiting
Hôpitaux Universitaires de Genève
Geneva
Bulgaria2 sites, 2 recruiting
- Not yet recruiting
Acibadem City Clinic Tokuda Hospital
Sofia
- Not yet recruiting
University Hospital Tsaritsa Yoanna ISUL
Sofia
Australia1 site, 1 recruiting
- Recruiting
Canberra Health Services
Canberra, Australian Capital Territory
Croatia1 site, 1 recruiting
- Not yet recruiting
Dubrava University Hospital
Zagreb
Germany1 site, 1 recruiting
- Not yet recruiting
University Heart Center Freiburg-Bad Krozingen
Bad Krozingen
About this study
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.
Read more
The study will include approximately 4,500 patients across centers in Switzerland, Germany, Poland, Croatia, Bulgaria, Cyprus, and Australia, with planned inclusion of sites in the UK. Patients are included in two arms. In the prospective arm, consecutive patients are enrolled at the time of their device procedure. In the retrospective arm, centers include patients they have already treated, using data already recorded during clinical care. Both arms use the same case report form and the same endpoint definitions. Participants are followed annually for up to ten 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.
- Conditions
- Cardiomyopathy, Secondary, Arrhythmias, Cardiac, Heart Failure, Pacing Induced Cardiomyopathy, Conduction System Pacing
- Medical subject headings
- Cardiomyopathies, Arrhythmias, Cardiac, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants developing PICM, defined as an absolute decline in left ventricular ejection fraction (LVEF) of ≥10 percentage points to <50% during follow-up after a CIED procedure
Measured: up to 10 years after the CIED procedure
Secondary outcomes (15)
Number of participants who died from any cause on follow-up
Measured: up to 10 years after the CIED procedure
Number of participants hospitalized for heart failure on follow-up
Measured: up to 10 years after the CIED procedure
Number of participants hospitalized for other cardiovascular events (excluding heart failure) on follow-up
Measured: up to 10 years after the CIED procedure
Number of participants hospitalized for non-cardiovascular reasons on follow-up
Measured: up to 10 years after the CIED procedure
Number of participants undergoing upgrade to CRT on follow-up
Measured: up to 10 years after the CIED procedure
Number of participants with device-related complications on follow-up
Measured: up to 10 years after the CIED procedure
Change in EQ-5D-5L Index Score from Baseline (range 0-1; higher scores indicate better quality of life)
Measured: at Baseline, 8 weeks, and annually to year 10
Change in patient satisfaction score with remote monitoring from Baseline (range 0-10; higher scores indicate higher satisfaction)
Measured: Baseline, 8 weeks, and annually to year 10
Total healthcare costs per patient for CSP versus right ventricular pacing, applying the PICM risk prediction score
Measured: up to 10 years after the CIED procedure
Incremental cost-effectiveness ratio (ICER) of CSP versus right ventricular pacing per quality-adjusted life year (QALY) gained, applying the PICM risk prediction score
Measured: up to 10 years after the CIED procedure
Inter-center and inter-country variation in CIED practice, including percentage of patients receiving CSP
Measured: up to 10 years after the CIED procedure
Average percentage of ventricular pacing on follow-up
Measured: up to 10 years after the CIED procedure
Number of participants with device-detected subclinical atrial fibrillation on follow-up
Measured: up to 10 years after the CIED procedure
Number of participants experiencing stroke, stratified by modified Rankin Score on follow-up
Measured: up to 10 years after the CIED procedure
Number of participants with moderate or severe tricuspid valve regurgitation on echocardiography on follow-up
Measured: up to 10 years after the CIED procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, SecondaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,500 participants (estimated)
- Target duration
- 120 Months
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikola A. Kozhuharov, PD Dr. med., Principal investigator, Inselspital, University Hospital Bern, Clinic of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276139
- Sponsor's protocol ID
- 2025-02109
- Other IDs
- 2025
- Acronym
- PACEVALUE
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The prediction model is published in full, including every coefficient, the baseline risk at each prediction horizon, the shrinkage applied and the functional forms, in sufficient detail for a predicted risk to be computed without contacting the investigators. Analyses are conducted within the collaboration under the applicable agreements and reported according to TRIPOD+AI.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing Advancements With Cost and Experience VALuation for Unified Patient-Led Clinical Evidence - the PACEVALUE Study
- ClinicalTrials.gov ID
- NCT07276139
- Acronym / sponsor ID
- PACEVALUE / 2025-02109
- Conditions
- Cardiomyopathy, Secondary, Arrhythmias, Cardiac, Heart Failure, Pacing Induced Cardiomyopathy, Conduction System Pacing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 include approximately 4,500 patients across centers in Switzerland, Germany, Poland, Croatia, Bulgaria, Cyprus, and Australia, with planned inclusion of sites in the UK. Patients are included in two arms. In the prospective arm, consecutive patients are enrolled at the time of their device procedure. In the retrospective arm, centers include patients they have already treated, using data already recorded during clinical care. Both arms use the same case report form and the same endpoint definitions. Participants are followed annually for up to ten 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 120 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults undergoing a cardiac implantable electronic device (CIED) procedure for standard clinical indications, included in two arms. In the prospective arm, consecutive patients at a participating center are enrolled at the time of the procedure. In the retrospective arm, centers include all consecutive patients who underwent a CIED procedure from a center-specific start date up to the date of data extraction, using data already recorded during clinical care. Participants are drawn from centers in Switzerland, Germany, Poland, Croatia, Bulgaria, Cyprus, and Australia, with planned activation of sites in the UK. The population includes patients receiving pacemakers, ICDs, or CRT devices; patients with existing CRT at baseline serve as a comparator. Both arms use the same case report form and the same endpoint definitions. Enrollment reflects diverse healthcare settings and demographics.
Key inclusion criteria (5 listed)
- Age ≥18 years at the time of the CIED procedure
- Undergoing, or having undergone, a CIED procedure (permanent pacemaker, ICD, or CRT)
- A lawful basis for inclusion: signed informed consent prior to enrollment in the prospective arm, or a lawful basis for the further use of health-related personal data in the retrospective arm
- Prospective arm only: willing and able to participate in long-term follow-up
- Prospective arm only: sufficient language comprehension (or support) to provide informed consent and complete PROMs/PREMs
Key exclusion criteria (2 listed)
- Prospective arm only: severe cognitive impairment without a legal representative
- A documented objection to the use of health-related data for research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants developing PICM, defined as an absolute decline in left ventricular ejection fraction (LVEF) of ≥10 percentage points to <50% during follow-up after a CIED procedure
Time frame: up to 10 years after the CIED procedure
15 secondary outcomes
Number of participants who died from any cause on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants hospitalized for heart failure on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants hospitalized for other cardiovascular events (excluding heart failure) on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants hospitalized for non-cardiovascular reasons on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants undergoing upgrade to CRT on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants with device-related complications on follow-up
Time frame: up to 10 years after the CIED procedure
Change in EQ-5D-5L Index Score from Baseline (range 0-1; higher scores indicate better quality of life)
Time frame: at Baseline, 8 weeks, and annually to year 10
Change in patient satisfaction score with remote monitoring from Baseline (range 0-10; higher scores indicate higher satisfaction)
Time frame: Baseline, 8 weeks, and annually to year 10
Total healthcare costs per patient for CSP versus right ventricular pacing, applying the PICM risk prediction score
Time frame: up to 10 years after the CIED procedure
Incremental cost-effectiveness ratio (ICER) of CSP versus right ventricular pacing per quality-adjusted life year (QALY) gained, applying the PICM risk prediction score
Time frame: up to 10 years after the CIED procedure
Inter-center and inter-country variation in CIED practice, including percentage of patients receiving CSP
Time frame: up to 10 years after the CIED procedure
Average percentage of ventricular pacing on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants with device-detected subclinical atrial fibrillation on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants experiencing stroke, stratified by modified Rankin Score on follow-up
Time frame: up to 10 years after the CIED procedure
Number of participants with moderate or severe tricuspid valve regurgitation on echocardiography on follow-up
Time frame: up to 10 years after the CIED procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The prediction model is published in full, including every coefficient, the baseline risk at each prediction horizon, the shrinkage applied and the functional forms, in sufficient detail for a predicted risk to be computed without contacting the investigators. Analyses are conducted within the collaboration under the applicable agreements and reported according to TRIPOD+AI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikola A. Kozhuharov, PD Dr. med. principal investigator
Inselspital, University Hospital Bern, Clinic of Cardiology
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, Secondary and Arrhythmias, Cardiac, run by Insel Gruppe AG, University Hospital Bern at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Poland, Switzerland, Bulgaria, Australia, Croatia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikola A. Kozhuharov, PD Dr. med. (+41 31 63 2 36 50, nikola.kozhuharov@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants developing PICM, defined as an absolute decline in left ventricular ejection fraction (LVEF) of ≥10 percentage points to <50% during follow-up after a CIED procedure (time frame: up to 10 years after the CIED procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.