Clinical trial NCT05148338: Prevention to Improve Outcomes After PVI
Official title: The Effectivity of Lifestyle Interventions and Prevention in Patients With Atrial Fibrillation Referred for Ablation; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Risk Reduction
Nurse's Role
Keywords: pulmonary vein isolation
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of hospital visits for cardioversion of AF and re-ablations
timeFrame: Up to 12 months after ablation or finishing risk treatment
Secondary outcomes:
measure: Number of hospital visits for cardioversion of AF
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: Number of reablations
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: The composite of mortality, stroke or hospitalization for heart failure or acute ischemic events.
timeFrame: Up to 12 months after ablation
measure: All-cause mortality
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: Number of strokes
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: Hospitalizations for heart failure or acute ischemic events
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: Quality of Life - EQ-5D
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: Quality of Life - Atrial Fibrillation Effect on QualiTy of life survey (AFEQT)
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: Treatment burden - Treatment Burden Questionnaire (TBQ)
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: Rate of Success for ablation
timeFrame: From 3 months after ablation up to 12 months after ablation
measure: Number of Cancellations of index ablation
timeFrame: Up to 12 months after finishing risk factor treatment
Other outcomes:
measure: Medical costs
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: Cost-effectiveness ratio
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: Patient value
timeFrame: Up to 12 months after ablation or finishing risk treatment
measure: Ablation - procedure times
timeFrame: During ablation
measure: Ablation - DAP
timeFrame: During ablation
measure: Weight target achievement
timeFrame: Up to 12 months after finishing risk factor treatment
measure: Blood pressure target achievement
timeFrame: Up to 12 months after finishing risk factor treatment
measure: Success of treatment of sleep apnea
timeFrame: Up to 12 months after finishing risk factor treatment
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Lukas Dekker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: