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Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PVI Plus Catheter Ablation
PVI Alone
Sponsored by
Aurora Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

(Step 1 - Registration)

  • The subject is 18 years of age or older
  • Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view
  • performed within 6 months)
  • Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III)
  • Provided written informed consent
  • Be eligible for an AF ablation procedure for Paroxysmal AF

(Step 2 - Randomization)

  • Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation

Exclusion Criteria:

(Step 1 - Registration)

  • Pregnant or planning to become pregnant during study
  • Co-morbid medical conditions that limit one-year life expectancy
  • Previous cardiac surgery
  • Patients who have active infection or sepsis
  • Patients with esophageal ulcers strictures and varices
  • Patients who are contraindicated for anticoagulants such as heparin and warfarin
  • Patients who are being treated for ventricular arrhythmias
  • Patients who have had a previous left atrial catheter ablation for AF (does not
  • include ablation for AFL or other supraventricular arrhythmias)
  • Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
  • Not competent to legally represent him or herself (e.g., requires a guardian or
  • caretaker as a legal representative)

(Step 2 Randomization)

  • Not able to receive additional linear or focal intracardiac catheter ablation

Sites / Locations

  • Aurora Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PVI Plus Catheter Ablation

PVI Alone

Arm Description

Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.

Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.

Outcomes

Primary Outcome Measures

Time to recurrence
Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.

Secondary Outcome Measures

Time to recurrence following intervention
Time to recurrence following intervention

Full Information

First Posted
March 13, 2017
Last Updated
December 13, 2017
Sponsor
Aurora Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT03115554
Brief Title
Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation
Official Title
Comparison of Pulmonary Vein Isolation Plus Additional Catheter Ablation or Pulmonary Vein Isolation Alone for the Treatment of Atrial Fibrillation for Patients With Paroxysmal Atrial Fibrillation: A Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Patients did not want to be randomized in their procedure.
Study Start Date
April 6, 2017 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
August 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aurora Health Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
PVI Plus Catheter Ablation
Arm Type
Active Comparator
Arm Description
Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.
Arm Title
PVI Alone
Arm Type
Active Comparator
Arm Description
Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.
Intervention Type
Procedure
Intervention Name(s)
PVI Plus Catheter Ablation
Intervention Description
Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.
Intervention Type
Procedure
Intervention Name(s)
PVI Alone
Intervention Description
Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.
Primary Outcome Measure Information:
Title
Time to recurrence
Description
Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to recurrence following intervention
Description
Time to recurrence following intervention
Time Frame
12 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (Step 1 - Registration) The subject is 18 years of age or older Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view performed within 6 months) Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III) Provided written informed consent Be eligible for an AF ablation procedure for Paroxysmal AF (Step 2 - Randomization) Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation Exclusion Criteria: (Step 1 - Registration) Pregnant or planning to become pregnant during study Co-morbid medical conditions that limit one-year life expectancy Previous cardiac surgery Patients who have active infection or sepsis Patients with esophageal ulcers strictures and varices Patients who are contraindicated for anticoagulants such as heparin and warfarin Patients who are being treated for ventricular arrhythmias Patients who have had a previous left atrial catheter ablation for AF (does not include ablation for AFL or other supraventricular arrhythmias) Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) (Step 2 Randomization) Not able to receive additional linear or focal intracardiac catheter ablation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasbir Sra, MD
Organizational Affiliation
Aurora Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation

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