Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

Heart Failure Clinical Trial

— POLAR-HF  

Official title:

Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04461691
• Other study ID #: POLAR-HF
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2024
• Source: St. Josefs-Hospital Wiesbaden GmbH
• Contact: Joachim Ehrlich, MD
• Phone: +496111771201
• Email: jehrlich[@]joho.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cryoballon Ablation
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Germany	St. Josefs-Hospital Wiesbaden GmbH	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
St. Josefs-Hospital Wiesbaden GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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