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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04461691
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
St. Josefs-Hospital Wiesbaden GmbH

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Primary Outcome Measures (Number of recurrence) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 36 months ]
    Number of all-cause death

  2. Secondary Outcome Measures (procedural success) [ Time Frame: 36 months ]
    2. Incidence of acute procedural success assessed by successful isolation of all pulmonary veins

  3. Secondary Outcome Measures (rehospitalization) [ Time Frame: 36 months ]
    3. Number of subjects reporting a first unplanned rehospitalization for cardiovasvular causes

  4. Secondary Outcome Measures (procedure duration) [ Time Frame: 36 months ]
    4. Total procedure duration and left-atrial dwell time (in minutes)

  5. Secondary Outcome Measures (total time) [ Time Frame: 36 months ]
    5. Total fluoroscopy time (in minutes)

  6. Secondary Outcome Measures (total contrast use) [ Time Frame: 36 months ]
    6. Total contrast dye use (in milliliters)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461691


Locations
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Germany
St. Josefs-Hospital Wiesbaden GmbH Recruiting
Wiesbaden, Germany, 65189
Contact: Joachim Ehrlich, Prof. Dr.    +496111771201    jehrlich@joho.de   
Contact: Andreas Boehmer, Dr. med.    +496111771201    aboehmer@joho.de   
Sponsors and Collaborators
St. Josefs-Hospital Wiesbaden GmbH
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Responsible Party: St. Josefs-Hospital Wiesbaden GmbH
ClinicalTrials.gov Identifier: NCT04461691    
Other Study ID Numbers: POLAR-HF
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes