Patients' attitude towards a sham-controlled trial on pulmonary vein isolation in atrial fibrillation.
Tobias UheSamira BeimelRomy LanghammerTina StegmannGerhard HindricksUlrich LaufsNikolaos DagresRolf WachterPublished in: Clinical research in cardiology : official journal of the German Cardiac Society (2021)
With a participation rate of 40% in potential study participants, a sham-controlled trial for pulmonary vein isolation seems feasible. Patient-reported symptom relief after pulmonary vein isolation is in accordance with previous randomized open studies. The benefit of PVI should be rigorously evaluated in a sham-controlled trial.
Keyphrases
- double blind
- patient reported
- placebo controlled
- clinical trial
- open label
- study protocol
- phase iii
- atrial fibrillation
- end stage renal disease
- phase ii
- ejection fraction
- chronic kidney disease
- newly diagnosed
- heart failure
- prognostic factors
- physical activity
- randomized controlled trial
- minimally invasive
- peritoneal dialysis
- coronary artery disease
- mitral valve
- left atrial appendage
- human health
- risk assessment
- catheter ablation
- case control