Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation
Alster-Lost
Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials
2 other identifiers
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started May 2008
Longer than P75 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 9, 2009
CompletedFirst Posted
Study publicly available on registry
January 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFebruary 8, 2017
February 1, 2017
8.8 years
January 9, 2009
February 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
data collection in view of acute and chronic success rate
12 months
Secondary Outcomes (1)
data collection of complications in both groups and also procedure parameters
12 months
Study Arms (2)
1
ACTIVE COMPARATORablation: pulmonary vein isolation
2
ACTIVE COMPARATORablation: pulmonary vein isolation with additional ablation of fragmented potentials
Interventions
common pulmonary vein isolation with additional but also common ablation of fragmented potentials
Eligibility Criteria
You may qualify if:
- long standing persistent atrial fibrillation \> 6 months and \< 5 years
You may not qualify if:
- renal failure
- left atrial size \>55 mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asklepios Klinik St. Georg
Hamburg, Germany
Related Publications (1)
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.
PMID: 28687670DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karl-Heinz Kuck, PhD, MD
Asklepios Klinik St. Georg, Department of Cardiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2009
First Posted
January 12, 2009
Study Start
May 1, 2008
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
February 8, 2017
Record last verified: 2017-02