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Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

Primary Purpose

Paroxysmal Atrial Fibrillation, Catheter Ablation Strategies

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
catheter based pulmonary vein isolation
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • written informed consent
  • age > 18 years
  • paroxysmal atrial fibrillation

Exclusion Criteria:

  • structural heart disease
  • intracardiac thrombus
  • reversible causes of atrial fibrillation
  • inability to take warfarin

Sites / Locations

  • University Hospital Hamburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Loss of pace capture

Conventional

Arm Description

Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved catheter based pulmonary vein isolation

Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved. catheter based pulmonary vein isolation

Outcomes

Primary Outcome Measures

time to AF and AT recurrence
recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring

Secondary Outcome Measures

procedure duration
time needed to complete the procedure
procedure safety
complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed

Full Information

First Posted
November 4, 2012
Last Updated
August 27, 2022
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01724437
Brief Title
Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
Official Title
Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

5. Study Description

Brief Summary
to assess the near-term (12 months) efficacy of pulmonary vein isolation.
Detailed Description
The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Catheter Ablation Strategies

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Loss of pace capture
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved catheter based pulmonary vein isolation
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved. catheter based pulmonary vein isolation
Intervention Type
Device
Intervention Name(s)
catheter based pulmonary vein isolation
Intervention Description
catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice
Primary Outcome Measure Information:
Title
time to AF and AT recurrence
Description
recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring
Time Frame
12 months
Secondary Outcome Measure Information:
Title
procedure duration
Description
time needed to complete the procedure
Time Frame
completed (15 months)
Title
procedure safety
Description
complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed
Time Frame
up to three days after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: written informed consent age > 18 years paroxysmal atrial fibrillation Exclusion Criteria: structural heart disease intracardiac thrombus reversible causes of atrial fibrillation inability to take warfarin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Willems
Organizational Affiliation
Universitäres Herzzentrum Hamburg GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23644091
Citation
Steven D, Sultan A, Reddy V, Luker J, Altenburg M, Hoffmann B, Rostock T, Servatius H, Stevenson WG, Willems S, Michaud GF. Benefit of pulmonary vein isolation guided by loss of pace capture on the ablation line: results from a prospective 2-center randomized trial. J Am Coll Cardiol. 2013 Jul 2;62(1):44-50. doi: 10.1016/j.jacc.2013.03.059. Epub 2013 May 1.
Results Reference
derived

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Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

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