Prevention to Improve Outcomes After PVI

Not Applicable

Active, not recruiting

• Conditions: Risk Reduction; Atrial Fibrillation; Nurse's Role
• Interventions: Other: Comprehensive risk factor treatment; Other: Standard of care

• Registration Number: NCT05148338
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-08
• Study Start: 2021-12-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-07-29
• Study Completion: 2025-07-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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

  1. BMI ≥27 kg/m2,
  2. hyperlipidaemia (LDL-cholesterol >2.6 mmol/L or total cholesterol >5.0 mmol/L),
  3. hypertension (blood pressure >130/90 mmHg),
  4. diabetes mellitus with HbA1c ≥53 mmol/mol,
  5. active smoking,
  6. excess alcohol use (>14 equivalent units of alcohol / week)

Exclusion Criteria

• 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risk intervention group	Comprehensive risk factor treatment	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.
Control group	Standard of care	Standard of care. Treatment by cardiologist conform existing guidelines.

Primary Outcome Measures

Name	Time	Method
Number of hospital visits for cardioversion of AF and re-ablations	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

Secondary Outcome Measures

Name	Time	Method
The composite of mortality, stroke or hospitalization for heart failure or acute ischemic events.	Up to 12 months after ablation	Number of events. All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation.
Hospitalizations for heart failure or acute ischemic events	Up to 12 months after ablation or finishing risk treatment	Number of events. All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation.
Number of hospital visits for cardioversion of AF	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.
Quality of Life - EQ-5D	Up to 12 months after ablation or finishing risk treatment	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.
Rate of Success for ablation	From 3 months after ablation up to 12 months after 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.
Number of reablations	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.
All-cause mortality	Up to 12 months after ablation or finishing risk treatment	Any deaths occurring during the study.
Treatment burden - Treatment Burden Questionnaire (TBQ)	Up to 12 months after ablation or finishing risk treatment	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.
Number of Cancellations of index ablation	Up to 12 months after finishing risk factor treatment	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.
Number of strokes	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.
Quality of Life - Atrial Fibrillation Effect on QualiTy of life survey (AFEQT)	Up to 12 months after ablation or finishing risk treatment	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.

Trial Locations

Locations (1)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands