Atrial FibrillationPOPNCT05148338
Prevention to Improve Outcomes After PVI
A study testing Comprehensive risk factor treatment in people with Atrial Fibrillation and Risk Reduction, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia and has a rising prevalence due to an aging population. AF increases the patient's risk of hospitalization, heart failure and stroke and results into deterioration of quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Risk Reduction, Nurse's Role
- What is being tested?
- Comprehensive risk factor treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Dec 2021to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with paroxysmal or persistent symptomatic atrial fibrillation referred for initial catheter ablation
- Patients should be native Dutch speakers
- Patients are able to use the VitalHealth Engage platform on their own preferred device (tablet, mobile phone, computer)
- The patient has at least one of the following risks
- BMI ≥27 kg/m2,
- hyperlipidaemia (LDL-cholesterol >2.6 mmol/L or total cholesterol >5.0 mmol/L),
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- hypertension (blood pressure >130/90 mmHg),
- diabetes mellitus with HbA1c ≥53 mmol/mol,
- active smoking,
- excess alcohol use (>14 equivalent units of alcohol / week)
Who cannot join
- Longstanding persistent atrial fibrillation (persistent AF for more than 1 year)
- Permanent atrial fibrillation
- Asymptomatic atrial fibrillation
- Prior catheter ablation
- Paroxysmal atrial fibrillation consisting of one episode with a reversible cause (e.g. fever, surgery, thyroid crisis, ischemic)
- Severe valvular heart disease
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- Prior or soon foreseen implantation of cardiac device such as pacemaker or internal cardioverter defibrillator
- Unstable heart failure New York Heart Association (NYHA) IV, or heart failure necessitating admission <3 months before inclusion
- Cardiac surgery <3 months before inclusion or planned cardiac surgery
- Patient is not willing to use a mobile phone application or willing to undergo elaborate monitoring.
- Malignancy
- Life expectancy <1 year
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectivity of Lifestyle Interventions and Prevention in Patients With Atrial Fibrillation Referred for Ablation; a Randomized Controlled Trial
Atrial fibrillation (AF) is the most common cardiac arrhythmia and has a rising prevalence due to an aging population. AF increases the patient's risk of hospitalization, heart failure and stroke and results into deterioration of quality of life. Treatment of symptomatic AF consists of either antiarrhythmic medication or a pulmonary vein isolation (PVI) catheter ablation. However, lots of patients experience recurrence of AF in the first year after PVI.
Previous studies showed that PVI outcomes depend on the presence of different treatable risk factors that influence the substrate for AF. Those risk factors include obesity, hypertension, cholesterol, diabetes mellitus, alcohol use, smoking and obstructive sleep apnea syndrome. However, research into the effect of treatment of those risk factors mainly consists of observational studies. Currently, it is not clear to what extent patients will benefit from comprehensive risk factor treatment prior to PVI in terms of ablation success and quality of life.
Read more
The aim of the current randomized controlled trial is to determine the effect of a nurse-led, technology-supported, personalized care pathway on hospital admissions for cardioversions and re-ablation in patients with AF that are referred for ablation.
Patients included in this study will be randomized to either the intervention group receiving the comprehensive risk treatment before PVI or the control group receiving standard usual care. Patients in the intervention group will visit the specialized AF nurse outpatient clinic and receive a personalized treatment plan (with a maximal duration of 6 months) including lifestyle interventions and medication. This includes sleep apnea screening with a Home Sleep Apnea Test (WatchPAT). Patients will also use the VitalHealth Engage platform. The digital platform can be used at home to report AF complaints, send home measurement and complete questionnaires. Furthermore, it supports the nurse in administering effective lifestyle changes by offering the patient personalized content and education.
Both study groups will be followed up to 12 months after ablation, during which hospital admissions for cardioversion and re-ablation are evaluated. At baseline, AFEQT, EQ5D and TBQ quality of life questionnaires will be performed. The questionnaires will be repeated prior to ablation, at 3 and 12 months after ablation. At baseline, pre-ablation and after 12 months laboratory tests (such as cholesterol) will be performed to evaluate adherence to lifestyle interventions.
- Conditions
- Atrial Fibrillation, Risk Reduction, Nurse's Role
- Being tested
- Comprehensive risk factor treatment, Standard of care
- Keywords
- pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive risk factor treatmentOther
- Apnea screening with Home Sleep Apnea Test. Referral to sleep physician if apnea-hypopnea index (AHI) is greater than 5
- Weight management counseling by dietician if body mass index (BMI) is above 27 kg/m2
- Physical activity program under supervision of physiotherapist at a specialized cardiac rehabilitation centre if BMI is over 27 or if there are complaints during exercise
- Smoking cessation at specialized outpatient clinic
- Blood pressure control, lipid management, glycaemic control, alcohol intake reduction by specialized AF nurse
- Motivation and education through a digital health platform
Standard of careOther
Standard usual care: Treatment by cardiologist conform existing guidelines
| Study group | Role | What they receive |
|---|---|---|
| Risk intervention group | Experimental | Comprehensive risk factor management at specialized AF outpatient clinic concerning blood pressure, cholesterol, glycaemic control, physical inactivity, weight control, smoking, alcohol intake and sleep apnea. Receives: Other: Comprehensive risk factor treatment |
| Control group | Active comparator | Standard of care. Treatment by cardiologist conform existing guidelines. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital visits for cardioversion of AF and re-ablations
All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation. This means that events during the risk factor treatment period are also included
Measured: Up to 12 months after ablation or finishing risk treatment
Secondary outcomes (11)
Number of hospital visits for cardioversion of AF
All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation.
Measured: Up to 12 months after ablation or finishing risk treatment
Number of reablations
All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation.
Measured: Up to 12 months after ablation or finishing risk treatment
The composite of mortality, stroke or hospitalization for heart failure or acute ischemic events.
Number of events. All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation.
Measured: Up to 12 months after ablation
All-cause mortality
Any deaths occurring during the study.
Measured: Up to 12 months after ablation or finishing risk treatment
Number of strokes
All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation.
Measured: Up to 12 months after ablation or finishing risk treatment
Hospitalizations for heart failure or acute ischemic events
Number of events. All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation.
Measured: Up to 12 months after ablation or finishing risk treatment
Quality of Life - EQ-5D
Quality of Life as measured by the EuroQol 5 Dimensions (EQ-5D) questionnaire. The questionnaire compromises 5 dimensions describing different aspects of health and an overall health perception. The 5 dimensions can each be scored from level 1 to 5. Lower levels correspond with higher quality of life and higher levels correspond with lower quality of life. Overall health perception is scored with a visual analogue scale (VAS) ranging from 0 to 100, with lower values corresponding with worse outcomes and higher values corresponding to better outcomes.
Measured: Up to 12 months after ablation or finishing risk treatment
Quality of Life - Atrial Fibrillation Effect on QualiTy of life survey (AFEQT)
Quality of Life as measured by the AFEQT questionnaire. The questionnaire contains 21 questions on a seven point Likert scale. Overall score ranges from 0 to 100. A score of 0 corresponds with complete disability, while a score of 100 corresponds with no disability.
Measured: Up to 12 months after ablation or finishing risk treatment
Treatment burden - Treatment Burden Questionnaire (TBQ)
Treatment burden is the perception of cumulative work a patient has to perform to manage their health. The TBQ consists out of 15 items with a ten point rating scale. A higher score corresponds to a greater burden, while a lower score corresponds with a lower burden.
Measured: Up to 12 months after ablation or finishing risk treatment
Rate of Success for ablation
The ablation is considered to be successful if patients could stop their antiarrhythmics after 3 months (the blanking period) without recurrent arrhythmia. If patients develop recurrent arrhythmia and had to restart antiarrhythmics after the blanking period, the index ablation is considered unsuccessful.
Measured: From 3 months after ablation up to 12 months after ablation
Number of Cancellations of index ablation
Patients might experience absence of AF complaints after they have had effective treatment of their risk factors. The treating cardiologist might decide to cancel the index ablation if patients do not experience any AF complaints.
Measured: Up to 12 months after finishing risk factor treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start16 Dec 2021
- Primary completion29 Jul 2025 (estimated)
- Study completion29 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Dekker, Catharina Ziekenhuis Eindhoven
- Investigators
- Lukas Dekker, MD, PhD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148338
- Sponsor's protocol ID
- CZE2021.53
- Acronym
- POP
- Status last verified
- Aug 2024
- First submitted
- 25 Oct 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vermeer J, van Steenbergen G, Vervaat F, Grimm S, van Veghel D, Dekker L. The effect of integrated lifestyle modification on quality of life and cost-effectiveness in atrial fibrillation ablation - results from the POP-AF RCT. Eur Heart J Qual Care Clin Outcomes. 2026 Aug 28:qcag135. doi: 10.1093/ehjqcco/qcag135. Online ahead of print.
PubMed 42663016Vermeer J, Vinck T, de Louw B, Slingerland S, van 't Veer M, Regis M, Jansen JM, van den Heuvel E, Dekker L. Improving outcomes of AF ablation by integrated personalized lifestyle interventions: rationale and design of the prevention to improve outcomes of PVI (POP) trial. Clin Res Cardiol. 2023 Jun;112(6):716-723. doi: 10.1007/s00392-023-02185-5. Epub 2023 Mar 31.
PubMed 37000245
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectivity of Lifestyle Interventions and Prevention in Patients With Atrial Fibrillation Referred for Ablation; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05148338
- Acronym / sponsor ID
- POP / CZE2021.53
- Conditions
- Atrial Fibrillation, Risk Reduction, Nurse's Role
- Keywords
- pulmonary vein isolation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 29 Jul 2025 (estimated)
- Study completion
- 29 Jul 2025 (estimated)
- First posted
- 8 Dec 2021 (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.
Atrial fibrillation (AF) is the most common cardiac arrhythmia and has a rising prevalence due to an aging population. AF increases the patient's risk of hospitalization, heart failure and stroke and results into deterioration of quality of life. Treatment of symptomatic AF consists of either antiarrhythmic medication or a pulmonary vein isolation (PVI) catheter ablation. However, lots of patients experience recurrence of AF in the first year after PVI.
Previous studies showed that PVI outcomes depend on the presence of different treatable risk factors that influence the substrate for AF. Those risk factors include obesity, hypertension, cholesterol, diabetes mellitus, alcohol use, smoking and obstructive sleep apnea syndrome. However, research into the effect of treatment of those risk factors mainly consists of observational studies. Currently, it is not clear to what extent patients will benefit from comprehensive risk factor treatment prior to PVI in terms of ablation success and quality of life.
The aim of the current randomized controlled trial is to determine the effect of a nurse-led, technology-supported, personalized care pathway on hospital admissions for cardioversions and re-ablation in patients with AF that are referred for ablation.
Patients included in this study will be randomized to either the intervention group receiving the comprehensive risk treatment before PVI or the control group receiving standard usual care. Patients in the intervention group will visit the specialized AF nurse outpatient clinic and receive a personalized treatment plan (with a maximal duration of 6 months) including lifestyle interventions and medication. This includes sleep apnea screening with a Home Sleep Apnea Test (WatchPAT). Patients will also use the VitalHealth Engage platform. The digital platform can be used at home to report AF complaints, send home measurement and complete questionnaires. Furthermore, it supports the nurse in administering effective lifestyle changes by offering the patient personalized content and education.
Both study groups will be followed up to 12 months after ablation, during which hospital admissions for cardioversion and re-ablation are evaluated. At baseline, AFEQT, EQ5D and TBQ quality of life questionnaires will be performed. The questionnaires will be repeated prior to ablation, at 3 and 12 months after ablation. At baseline, pre-ablation and after 12 months laboratory tests (such as cholesterol) will be performed to evaluate adherence to lifestyle interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk intervention group | Experimental | Other: Comprehensive risk factor treatmentComprehensive risk factor management at specialized AF outpatient clinic concerning blood pressure, cholesterol, glycaemic control, physical inactivity, weight control, smoking, alcohol intake and sleep apnea. |
| Control group | Active comparator | Other: Standard of careStandard of care. Treatment by cardiologist conform existing guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with paroxysmal or persistent symptomatic atrial fibrillation referred for initial catheter ablation
- Patients should be native Dutch speakers
- Patients are able to use the VitalHealth Engage platform on their own preferred device (tablet, mobile phone, computer)
- The patient has at least one of the following risks
Key exclusion criteria (13 listed)
- Longstanding persistent atrial fibrillation (persistent AF for more than 1 year)
- Permanent atrial fibrillation
- Asymptomatic atrial fibrillation
- Prior catheter ablation
- Paroxysmal atrial fibrillation consisting of one episode with a reversible cause (e.g. fever, surgery, thyroid crisis, ischemic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive risk factor treatment1. Apnea screening with Home Sleep Apnea Test. Referral to sleep physician if apnea-hypopnea index (AHI) is greater than 5 2. Weight management counseling by dietician if body mass index (BMI) is above 27 kg/m2 3. Physical activity program under supervision of physiotherapist at a specialized cardiac rehabilitation centre if BMI is over 27 or if there are complaints during exercise 4. Smoking cessation at specialized outpatient clinic 5. Blood pressure control, lipid management, glycaemic control, alcohol intake reduction by specialized AF nurse 6. Motivation and education through a digital health platform | Other | Risk intervention group |
| Standard of careStandard usual care: Treatment by cardiologist conform existing guidelines | Other | Control group |
Primary outcome
Number of hospital visits for cardioversion of AF and re-ablations
Time frame: Up to 12 months after ablation or finishing risk treatment
All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation. This means that events during the risk factor treatment period are also included
11 secondary outcomes
Number of hospital visits for cardioversion of AF
Time frame: Up to 12 months after ablation or finishing risk treatment
Number of reablations
Time frame: Up to 12 months after ablation or finishing risk treatment
The composite of mortality, stroke or hospitalization for heart failure or acute ischemic events.
Time frame: Up to 12 months after ablation
All-cause mortality
Time frame: Up to 12 months after ablation or finishing risk treatment
Number of strokes
Time frame: Up to 12 months after ablation or finishing risk treatment
Hospitalizations for heart failure or acute ischemic events
Time frame: Up to 12 months after ablation or finishing risk treatment
Quality of Life - EQ-5D
Time frame: Up to 12 months after ablation or finishing risk treatment
Quality of Life - Atrial Fibrillation Effect on QualiTy of life survey (AFEQT)
Time frame: Up to 12 months after ablation or finishing risk treatment
Treatment burden - Treatment Burden Questionnaire (TBQ)
Time frame: Up to 12 months after ablation or finishing risk treatment
Rate of Success for ablation
Time frame: From 3 months after ablation up to 12 months after ablation
Number of Cancellations of index ablation
Time frame: Up to 12 months after finishing risk factor treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 42663016Vermeer J, van Steenbergen G, Vervaat F, Grimm S, van Veghel D, Dekker L. The effect of integrated lifestyle modification on quality of life and cost-effectiveness in atrial fibrillation ablation - results from the POP-AF RCT. Eur Heart J Qual Care Clin Outcomes. 2026 Aug 28:qcag135. doi: 10.1093/ehjqcco/qcag135. Online ahead of print.
- Derived from this study: PubMed 37000245Vermeer J, Vinck T, de Louw B, Slingerland S, van 't Veer M, Regis M, Jansen JM, van den Heuvel E, Dekker L. Improving outcomes of AF ablation by integrated personalized lifestyle interventions: rationale and design of the prevention to improve outcomes of PVI (POP) trial. Clin Res Cardiol. 2023 Jun;112(6):716-723. doi: 10.1007/s00392-023-02185-5. Epub 2023 Mar 31.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lukas Dekker, MD, PhD principal investigator
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive risk factor treatment in people with Atrial Fibrillation and Risk Reduction, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospital visits for cardioversion of AF and re-ablations (time frame: Up to 12 months after ablation or finishing risk treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05148338, which also lists 2 linked publications.
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 21 Aug 2024.