NCT04461691Completed
Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
Source: ClinicalTrials.gov · Last updated 12 Sept 2025
Brief summary (registry, in English)
The combination of atrial fibrillation (AF) and heart failure (HF) is common and implies a poor prognosis. Pulmonary vein isolation is an established method for the treatment of symptomatic AF in patients with normal heart function and has been shown to be more effective than drug therapy. Recently, radiofrequency ablation has shown a positive effect in patients with AF and HF. POLAR-HF has been designed to investigate efficacy and safety of cryoballoon pulmonary vein isolation in patients with paroxysmal or persistent AF and severe HF (LVEF ≤ 40%).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1420 (actual)
- First submitted
- 8 May 2020
- Start date
- 1 Jan 2018
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbH
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT04461691
What you commit to
- Study type: Interventional
- Participants enrolled: 1420
- From 1 Jan 2018 to the primary completion date, 31 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age under 18 years
Other
- Pregnancy
- Lack of consent capacity
Who the study is looking for
- Symptomatic paroxysmal or persistent atrial fibrillation
- Patients with severe heart failure (LVEF ≤40%, assigned to heart failure group)
- Patients with normal cardiac function (assigned to control group)
- Age \> 18 years
- Consent capacity
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Josefs-Hospital Wiesbaden GmbH Coordinator of this site? Confirm its status | Wiesbaden | Germany | Unknown status |
Related publications
- Pulmonary Vein Isolation Only for Atrial Fibrillation With Heart Failure (POLAR-HF).JACC Clin Electrophysiol · 2026 · PMID 41263723
This page is information, not medical advice. Discuss any trial with your doctor.