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Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation (Alster-Lost)

Primary Purpose

Atrial Fibrillation, Tachycardia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
pulmonary vein isolation
pulmonary vein isolation with additional ablation of fragmented potentials
Sponsored by
Asklepios proresearch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • long standing persistent atrial fibrillation > 6 months and < 5 years

Exclusion Criteria:

  • renal failure
  • left atrial size >55 mm

Sites / Locations

  • Asklepios Klinik St. Georg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

ablation: pulmonary vein isolation

ablation: pulmonary vein isolation with additional ablation of fragmented potentials

Outcomes

Primary Outcome Measures

data collection in view of acute and chronic success rate

Secondary Outcome Measures

data collection of complications in both groups and also procedure parameters

Full Information

First Posted
January 9, 2009
Last Updated
February 6, 2017
Sponsor
Asklepios proresearch
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1. Study Identification

Unique Protocol Identification Number
NCT00820625
Brief Title
Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation
Acronym
Alster-Lost
Official Title
Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asklepios proresearch

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing persistent AF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
ablation: pulmonary vein isolation
Arm Title
2
Arm Type
Active Comparator
Arm Description
ablation: pulmonary vein isolation with additional ablation of fragmented potentials
Intervention Type
Procedure
Intervention Name(s)
pulmonary vein isolation
Intervention Description
common pulmonary vein isolation procedure
Intervention Type
Procedure
Intervention Name(s)
pulmonary vein isolation with additional ablation of fragmented potentials
Intervention Description
common pulmonary vein isolation with additional but also common ablation of fragmented potentials
Primary Outcome Measure Information:
Title
data collection in view of acute and chronic success rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
data collection of complications in both groups and also procedure parameters
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: long standing persistent atrial fibrillation > 6 months and < 5 years Exclusion Criteria: renal failure left atrial size >55 mm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Kuck, PhD, MD
Organizational Affiliation
Asklepios Klinik St. Georg, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28687670
Citation
Fink T, Schluter M, Heeger CH, Lemes C, Maurer T, Reissmann B, Riedl J, Rottner L, Santoro F, Schmidt B, Wohlmuth P, Mathew S, Sohns C, Ouyang F, Metzner A, Kuck KH. Stand-Alone Pulmonary Vein Isolation Versus Pulmonary Vein Isolation With Additional Substrate Modification as Index Ablation Procedures in Patients With Persistent and Long-Standing Persistent Atrial Fibrillation: The Randomized Alster-Lost-AF Trial (Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation). Circ Arrhythm Electrophysiol. 2017 Jul;10(7):e005114. doi: 10.1161/CIRCEP.117.005114.
Results Reference
derived

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Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation

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