Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure (POLAR-HF)

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%).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Atrial Fibrillation; Cryoballon Ablation
• Intervention / Treatment: Procedure: Cryoballoon Pulmonary Vein Isolation

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joachim Ehrlich, MD; Phone Number: +496111771201; Email: jehrlich@joho.de
• Study Contact Backup: Name: Andreas Boehmer, MD; Phone Number: +496111771201

Study Locations

• Germany
  • Wiesbaden, Germany, 65189
    • Recruiting
    • St. Josefs-Hospital Wiesbaden GmbH
    • Contact: Joachim Ehrlich, Prof. Dr.; Phone Number: +496111771201; Email: jehrlich@joho.de
    • Contact: Andreas Boehmer, Dr. med.; Phone Number: +496111771201; Email: aboehmer@joho.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Heart Failure; 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; 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.
Other: Normal cardiac function; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measures (number of deaths)	Number of all-cause death	60 months
Secondary Outcome Measures (procedural success)	2. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins	60 months
Secondary Outcome Measures (rehospitalization)	3. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes	60 months
Secondary Outcome Measures (procedure duration)	4. Total procedure duration and left-atrial dwell time (in minutes)	60 months
Secondary Outcome Measures (total time)	5. Total fluoroscopy time (in minutes)	60 months
Secondary Outcome Measures (total contrast use)	6. Total contrast dye use (in milliliters)	60 months

Collaborators and Investigators

• Sponsor: St. Josefs-Hospital Wiesbaden GmbH
• Investigators: Principal Investigator: Joachim Ehrlich, MD, St. Josefs-Hospital Wiesbaden GmbH; Principal Investigator: Andreas Boehmer, MD, St. Josefs-Hospital Wiesbaden GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: POLAR-HF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No