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

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

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: PVI Plus Catheter Ablation; Procedure: PVI Alone

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PVI Plus Catheter Ablation; Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.	Procedure: PVI Plus Catheter Ablation; Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.
Active Comparator: PVI Alone; Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.	Procedure: PVI Alone; Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recurrence	Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recurrence following intervention	Time to recurrence following intervention	12 months post intervention

Collaborators and Investigators

• Sponsor: Aurora Health Care
• Investigators: Principal Investigator: Jasbir Sra, MD, Aurora Health Care

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2017
• Primary Completion (Actual): August 3, 2017
• Study Completion (Actual): August 3, 2017

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 16-74

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No