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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Josefs-Hospital Wiesbaden GmbH
Coordinator of this site? Confirm its status
WiesbadenGermanyUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.