CClinicalTrials.gg
TerminatedNCT02019238RASTA XTUpdated Aug 22, 2016

Second Study to Assess Different Ablation Strategies in Achieving Long-Term Arrhythmia Control in Patients With Persistent or Long Standing Persistent Atrial Fibrillation

An interventional study of Pulmonary Vein Isolation procedure in Atrial Fibrillation, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-22.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment

Why this study was terminated
PI discretion
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Pulmonary vein isolation (PVI) combined with empiric ablation of either common sites of non-PV triggers of Atrial Fibrillation (AF) and locations that may sustain stable AF sources should be more efficacious than PVI combined with ablation of only documented non-PV triggers of AF in achieving long-term arrhythmia control in patients with persistent or long standing persistent AF.

Read the detailed description

The AF ablation procedure has evolved considerably and currently the most accepted technique involves creation of circumferential Radiofrequency Ablation lesions around PV ostia (encircling wide areas around the left and right sided veins). We have found that targeting areas outside the pulmonary veins that trigger atrial premature beats of AF is important for optimizing the success of AF ablation. The methodology of additional lesion creation remains non-uniform, lacks mechanistic insights, and there is paucity of prospective randomized comparison on the long term efficacy and safety of various lesion combinations in achieving AF control. Our group recently conducted randomized study (RASTA Trial) that compared PVI combined with ablation of documented non-PV triggers (standard AF ablation strategy) of AF to two other strategies i.e. 1. PVI combined with empiric ablation at common non-PV trigger sites of AF, 2. PVI combined with ablation of locations demonstrating complex fractionated electrograms. In this study comprising 156 subjects with persistent and/or long standing persistent AF, the investigators found that the standard AF ablation strategy was as efficacious as PVI combined with empiric ablation at common non-PV trigger sites of AF and both of these approaches were significantly better than PVI combined with ablation of locations demonstrating complex fractionated electrograms. Our study also showed that when compared to the standard AF ablation strategy (PVI combined with ablation of documented non PV AF triggers), PVI combined with empiric ablation at common locations of AF triggers in the left and right atria showed 22% higher odds of achieving freedom from atrial arrhythmias and 33% higher odds of achieving arrhythmia control at one year. Although this difference may have been clinically meaningful, it did not reach statistical significance because this study was powered to test for a difference of ≥30% between groups. Thus, in the current proposal the investigators hope to show statistical difference in the outcomes between these two strategies by increasing the sample size which will provide adequate power to show a 20% difference in the primary outcome. Also, the investigators hope to enhance the outcome in the study arm (PVI combined with empiric ablation at common locations of AF triggers) by also targeting empirically locations in the left and right atria that have been shown in recent studies to be focal sources and rotors that maintain AF.

02

Conditions studied

  • Atrial Fibrillation

Browse trials for

03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 56 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

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
Yes

Inclusion criteria

  • All patients of age ≥ 18 years, undergoing their first ablation procedure that meet American College of Cardiology / American Heart Association defined criteria for persistent or long standing persistent AF will be eligible to participate in the proposed study. This includes patients with a history of AF episodes lasting at least 7 days and requiring at least 2 cardioversions.

Exclusion criteria

Exclusion Criteria:

  • Patients with paroxysmal AF (self-terminating episodes lasting \< 7 day)
  • Patients who have had a previous AF ablation procedure
  • Failure to obtain informed consent
  • Patients \< 18 years of age. Investigators will plan to exclude paroxysmal AF patients and concentrate on patients with persistent or long standing persistent AF who may require further ablation to achieve better outcomes. Patients who have undergone previous AF ablation procedure will be excluded since the prior methodology used may confound the results of this study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
56 participants (actual)

Study arms

  • Placebo comparator
    Group 1-Standard PVI ablation

    Pulmonary Vein Isolation procedure combined with ablation of documented non-PV triggers of AF

    Other: Pulmonary Vein Isolation procedure

  • Active comparator
    Group 2-PVI with empiric ablation

    Pulmonary Vein Isolation procedure combined with empiric ablation of common sites of non-PV triggers of AF and locations that may sustain AF sources on long term arrhythmia control

    Other: Pulmonary Vein Isolation procedure

Interventions

  • OtherPulmonary Vein Isolation procedure

    comparing the efficacy of PVI ablation vs PVI combined with empiric ablation

    Also known as: PVI ablation procedure

06

What researchers measure

Primary outcomes

  1. Primary

    Compare PVI strategies in group 1 (documented non-PV triggers of AF) to group 2 (PVI combined with empiric ablation of common sites) over 12 months to assess for recurrence of atrial fibrillation.

    Time frame: 1 year

07

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02019238
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Dec 24, 2013
Start date
Aug 2013
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Aug 22, 2016

Study contacts

Sanjay Dixit, MD
principal investigator · University of Pensylvania

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion