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TerminatedNCT03115554Updated Oct 3, 2024

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

An interventional study of PVI Plus Catheter Ablation and PVI Alone in Atrial Fibrillation, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment

Why this study was terminated
Patients did not want to be randomized in their procedure.
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 2 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.

Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.

Browse Wake Forest University Health Sciences studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedurePVI Plus Catheter Ablation

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

  • ProcedurePVI Alone

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

06

What researchers measure

Primary outcomes

  1. Time to recurrence

    Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.

    Time frame: 12 months

Secondary outcomes

  1. Time to recurrence following intervention

    Time to recurrence following intervention

    Time frame: 12 months post intervention

07

Study locations

1 site
  • Aurora Health Care
    Milwaukee, Wisconsin 53215, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2017 to primary completion in Aug 2017, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2017
First posted
Apr 14, 2017
StartActual
Apr 6, 2017
Primary completionActual
Aug 3, 2017
CompletionActual
Aug 3, 2017
Last update
Oct 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03115554
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Apr 14, 2017
Start date
Apr 6, 2017
Primary completion
Aug 3, 2017
Completion
Aug 3, 2017
Last update
Oct 3, 2024

Study contacts

Jasbir Sra, MD
principal investigator · Wake Forest University Health Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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