NCT04461691

Brief Summary

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%).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,420

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

7.1 years

First QC Date

May 8, 2020

Last Update Submit

September 11, 2025

Conditions

Atrial FibrillationHeart FailureCryoballon Ablation

Outcome Measures

Primary Outcomes (2)

  • Primary Outcome Measures (Number of recurrence)

    Number of subjects with recurrence of atrial fibrillation, atrial flutter, atrial tachycardia or re-ablation after a blanking Period of 90 days after the initial cryoablation procedure

    60 months

  • Primary Outcome Measures (number of safety events)

    2\. Number of subjects with a primary safety event including a composite of death from any cause, stroke or transient ischemic attack and serious procedure-related adverse events (Major Bleeding by International Society on Thrombosis and Hemostasis (ISTH) criteria, pericardial effusion, cerebrovascular or systemic embolism, phrenic paresis, major groin site complications requiring treatment)

    60 months

Secondary Outcomes (6)

  • Secondary Outcome Measures (number of deaths)

    60 months

  • Secondary Outcome Measures (procedural success)

    60 months

  • Secondary Outcome Measures (rehospitalization)

    60 months

  • Secondary Outcome Measures (procedure duration)

    60 months

  • Secondary Outcome Measures (total time)

    60 months

  • +1 more secondary outcomes

Study Arms (2)

Heart Failure

OTHER

Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.

Procedure: Cryoballoon Pulmonary Vein Isolation

Normal cardiac function

OTHER

Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.

Procedure: Cryoballoon Pulmonary Vein Isolation

Interventions

Cryoballoon Pulmonary Vein IsolationPROCEDURE

Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.

Heart FailureNormal cardiac function

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age under 18 years
  • Pregnancy
  • Lack of consent capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, 65189, Germany

Location

Related Publications (1)

  • Boehmer AA, Rothe M, Andrade JG, Wiedenmann L, Spork P, Schneider KY, Nussbaum E, Keim C, Weiss P, Dobre BC, Feickert S, Ruckes C, Dyrda K, Kaess BM, Nattel S, Ehrlich JR. Pulmonary Vein Isolation Only for Atrial Fibrillation With Heart Failure (POLAR-HF). JACC Clin Electrophysiol. 2025 Nov 19:S2405-500X(25)00812-6. doi: 10.1016/j.jacep.2025.09.041. Online ahead of print.

    PMID: 41263723DERIVED

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joachim Ehrlich, MD

    St. Josefs-Hospital Wiesbaden GmbH

    PRINCIPAL INVESTIGATOR

  • Andreas Boehmer, MD

    St. Josefs-Hospital Wiesbaden GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

July 8, 2020

Study Start

January 1, 2018

Primary Completion

January 31, 2025

Study Completion

August 31, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

DE(1)