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

Primary Purpose

Atrial Fibrillation, Heart Failure, Cryoballon Ablation

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cryoballoon Pulmonary Vein Isolation
Sponsored by
St. Josefs-Hospital Wiesbaden GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Josefs-Hospital Wiesbaden GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Heart Failure

Normal cardiac function

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

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

Full Information

First Posted
May 8, 2020
Last Updated
April 16, 2023
Sponsor
St. Josefs-Hospital Wiesbaden GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04461691
Brief Title
Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
Acronym
POLAR-HF
Official Title
Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Josefs-Hospital Wiesbaden GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Heart Failure, Cryoballon Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart Failure
Arm Type
Other
Arm Description
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.
Arm Title
Normal cardiac function
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cryoballoon Pulmonary Vein Isolation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Outcome Measures (Number of recurrence)
Description
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
Time Frame
60 months
Title
Primary Outcome Measures (number of safety events)
Description
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)
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Secondary Outcome Measures (number of deaths)
Description
Number of all-cause death
Time Frame
60 months
Title
Secondary Outcome Measures (procedural success)
Description
2. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins
Time Frame
60 months
Title
Secondary Outcome Measures (rehospitalization)
Description
3. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes
Time Frame
60 months
Title
Secondary Outcome Measures (procedure duration)
Description
4. Total procedure duration and left-atrial dwell time (in minutes)
Time Frame
60 months
Title
Secondary Outcome Measures (total time)
Description
5. Total fluoroscopy time (in minutes)
Time Frame
60 months
Title
Secondary Outcome Measures (total contrast use)
Description
6. Total contrast dye use (in milliliters)
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joachim Ehrlich, MD
Phone
+496111771201
Email
jehrlich@joho.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Boehmer, MD
Phone
+496111771201
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Ehrlich, MD
Organizational Affiliation
St. Josefs-Hospital Wiesbaden GmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Boehmer, MD
Organizational Affiliation
St. Josefs-Hospital Wiesbaden GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Josefs-Hospital Wiesbaden GmbH
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joachim Ehrlich, Prof. Dr.
Phone
+496111771201
Email
jehrlich@joho.de
First Name & Middle Initial & Last Name & Degree
Andreas Boehmer, Dr. med.
Phone
+496111771201
Email
aboehmer@joho.de

12. IPD Sharing Statement

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Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

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