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Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation (LALA-LAND-AF)

Primary Purpose

Persistent or Long-standing Persistent Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Control intervention
Experimental intervention
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent or Long-standing Persistent Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

  1. Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained >7 days or >12 months, respectively)
  2. Age ≥18 and ≤80 years
  3. Indication for AF ablation as per current guidelines

Exclusion Criteria:

  1. Missing informed consent
  2. LAA diameter >25mm 10mm distant from circumflex artery assessed by TEE
  3. Paroxysmal atrial fibrillation
  4. Long-standing persistent atrial fibrillation with a continuous AF duration of >4 years
  5. Previous pulmonary vein isolation or MAZE surgery
  6. Previous led atrial appendage closure or surgical excision
  7. Left atrial diameter >60 mm at baseline
  8. Left atrial thrombus at baseline

Sites / Locations

  • Clinic for Rhythmologiy Luebeck, Schleswig-Holstein GermanyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Group 1

Group 2

Arm Description

Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone

Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation

Outcomes

Primary Outcome Measures

Time until any documented episode of ATa
Time until any documented episode of atrial tachyarrhythmia (ATa: atrial fibrillation or atrial tachycardia) lasting longer than 30 seconds within 3-12 months after index ablation without antiarrhythmic therapy

Secondary Outcome Measures

Full Information

First Posted
December 18, 2019
Last Updated
May 23, 2022
Sponsor
University of Luebeck
Collaborators
IHF GmbH - Institut für Herzinfarktforschung
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1. Study Identification

Unique Protocol Identification Number
NCT04240366
Brief Title
Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Acronym
LALA-LAND-AF
Official Title
Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck
Collaborators
IHF GmbH - Institut für Herzinfarktforschung

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent or Long-standing Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation
Intervention Type
Procedure
Intervention Name(s)
Control intervention
Other Intervention Name(s)
Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone
Intervention Description
patients treated with balloon-based ablation of AF by PVI
Intervention Type
Procedure
Intervention Name(s)
Experimental intervention
Other Intervention Name(s)
Experimental: Group 2 Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation
Intervention Description
patients treated with balloon-based ablation of AF by PVI
Primary Outcome Measure Information:
Title
Time until any documented episode of ATa
Description
Time until any documented episode of atrial tachyarrhythmia (ATa: atrial fibrillation or atrial tachycardia) lasting longer than 30 seconds within 3-12 months after index ablation without antiarrhythmic therapy
Time Frame
3 - 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained >7 days or >12 months, respectively) Age ≥18 and ≤80 years Indication for AF ablation as per current guidelines Exclusion Criteria: Missing informed consent LAA diameter >25mm 10mm distant from circumflex artery assessed by TEE Paroxysmal atrial fibrillation Long-standing persistent atrial fibrillation with a continuous AF duration of >4 years Previous pulmonary vein isolation or MAZE surgery Previous led atrial appendage closure or surgical excision Left atrial diameter >60 mm at baseline Left atrial thrombus at baseline
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cornelia Wolf
Phone
+49451500
Ext
44672
Email
Cornelia.Wolf@uksh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Tilz, Prof. Dr.
Organizational Affiliation
UKSH - Herzzentrum Lübeck - Section Electrophysiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christian Heeger, PD Dr.
Organizational Affiliation
UKSH - Herzzentrum Lübeck - Section Electrophysiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland Tilz, Prof. Dr.
Email
roland.tilz@uksh.de

12. IPD Sharing Statement

Learn more about this trial

Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation

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