High-Intensity Interval Training prior to Pulmonary Vein Ablation in the Treatment of Atrial Fibrillation – a prospective, randomized controlled trial: Prehabilitation Study of the Cologne ExAfib Trial

Phase 2

Recruiting

Conditions: I48.0
Paroxysmal atrial fibrillation

Registration Number: DRKS00017836

Lead Sponsor: Deutsche Sporthochschule Köln

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Male and female patients
- between the ages of 40 and 80 years
- symptomatic paroxysmal atrial fibrillation (EHRA = 2)

Exclusion Criteria

< 40 or > 80 years of age
- significant limitation to the exercise of the intervention-arms
- BMI = 35
- participation in regular aerobic or resistance exercise training in the last 6 months (> 60 minutes/week)
- previous open heart surgery
- left ventricular ejection fraction < 40% during sinus rhythm
- significant valve disease
- implanted cardiac pacemaker, ICD or resynchronization therapy
- coronary artery disease without complete revascularization
- unstable Angina
- uncontrolled arrhythmias causing unstable conditions
- uncontrolled hypertension
- uncontrolled Diabetes mellitus
- prior pulmonary vein ablation

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation: time to ECG-documented recurrence<br><br>Burden of atrial fibrillation: episodes documented during Holter-ECG and questionnaire<br><br>Data collection T0 (pre exercise intervention) T1 (3 months after ablation) T2 (12 months after ablation).

Secondary Outcome Measures

Name	Time	Method
Safety and Feasibility<br>PVI-associated complications<br>Physical fitness (VO2peak and strength)<br>Muscle strength<br>Subjective quality of life (SF-36)<br>Major adverse cardiovascular events (MACE): Stroke, myocardial infarction, death from cardiovascular cause<br>Minor adverse events<br>Adherence rate<br>AF-associated hospitalization<br>Body composition<br>inflammatory markers (CRP, Interleukins)<br>Collagen turnover markers<br>Cardiac function (echocardiography incl. strain analysis)<br>Blood pressure (24h)<br>Arterial stiffness (pulse wave analysis)<br>Heart rate (24h: min, max, average)<br>HRV (in sinus rhythm)<br>Muscle hypertrophy (diameter of Vastus lateralis)<br><br>Data collection T0 (pre exercise intervention) T1 (3 months after ablation) T2 (12 months after ablation).