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

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ClinicalTrials.gov Identifier: NCT00820625
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Asklepios proresearch

Tracking Information
First Submitted Date  ICMJE January 9, 2009
First Posted Date  ICMJE January 12, 2009
Last Update Posted Date February 8, 2017
Study Start Date  ICMJE May 2008
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
data collection in view of acute and chronic success rate [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
data collection of complications in both groups and also procedure parameters [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation
Official Title  ICMJE Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Tachycardia
Intervention  ICMJE
  • Procedure: pulmonary vein isolation
    common pulmonary vein isolation procedure
  • Procedure: pulmonary vein isolation with additional ablation of fragmented potentials
    common pulmonary vein isolation with additional but also common ablation of fragmented potentials
Study Arms  ICMJE
  • Active Comparator: 1
    ablation: pulmonary vein isolation
    Intervention: Procedure: pulmonary vein isolation
  • Active Comparator: 2
    ablation: pulmonary vein isolation with additional ablation of fragmented potentials
    Intervention: Procedure: pulmonary vein isolation with additional ablation of fragmented potentials
Publications * Fink T, Schlüter 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). pii: e005114. doi: 10.1161/CIRCEP.117.005114.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2017)
124
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2009)
108
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • renal failure
  • left atrial size >55 mm
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00820625
Other Study ID Numbers  ICMJE 1787
PV 2961 ( Other Identifier: Ethical Board Hamburg )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Asklepios proresearch
Study Sponsor  ICMJE Asklepios proresearch
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karl-Heinz Kuck, PhD, MD Asklepios Klinik St. Georg, Department of Cardiology
PRS Account Asklepios proresearch
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP