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

• Sponsor: St. Josefs-Hospital Wiesbaden GmbH (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04461691
• Collaborator: (none)
• Enrollment: 390
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 71
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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%).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Heart Failure; Cryoballon Ablation	Procedure: Cryoballoon Pulmonary Vein Isolation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 390 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open labelOpen label
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
• Actual Study Start Date: Jan 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Primary Outcome Measures (Number of recurrence) [36 months]

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

2. Primary Outcome Measures (number of safety events) [36 months]

   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)

Secondary Outcome Measures

1. Secondary Outcome Measures (number of deaths) [36 months]

   Number of all-cause death

2. Secondary Outcome Measures (procedural success) [36 months]

   2. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins

3. Secondary Outcome Measures (rehospitalization) [36 months]

   3. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes

4. Secondary Outcome Measures (procedure duration) [36 months]

   4. Total procedure duration and left-atrial dwell time (in minutes)

5. Secondary Outcome Measures (total time) [36 months]

   5. Total fluoroscopy time (in minutes)

6. Secondary Outcome Measures (total contrast use) [36 months]

   6. Total contrast dye use (in milliliters)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Josefs-Hospital Wiesbaden GmbH	Wiesbaden		Germany	65189

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Josefs-Hospital Wiesbaden GmbH
• ClinicalTrials.gov Identifier: NCT04461691
• Other Study ID Numbers: POLAR-HF
• First Posted: Jul 8, 2020
• Last Update Posted: Apr 8, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure; Atrial Fibrillation

Study Results

No Results Posted as of Apr 8, 2022