Prevention to Improve Outcomes After PVI (POP)

Catharina Hospital

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Risk Reduction; Nurse's Role

Treatments: Other: Comprehensive risk factor treatment; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT05148338

CZE2021.53

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Risk intervention group

Experimental group

Description:

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.

Treatment:

Other: Comprehensive risk factor treatment

Control group

Active Comparator group

Description:

Standard of care. Treatment by cardiologist conform existing guidelines.

Treatment:

Other: Standard of care