NCT02533843

Brief Summary

Specific Aim: This prospective randomized study aims to compare the impact of three different catheter ablation approaches on long-term procedure outcome in terms of arrhythmia recurrence in persistent (PeAF) and long-standing persistent atrial fibrillation (LSPAF) patients. The three strategies to be evaluated are 1) ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA), 2) ablation at sources guided by FIRMap + conventional pulmonary vein antrum isolation (PVAI) and 3) Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial electrograms (CFAE).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 atrial-fibrillation

Timeline
Completed

Started Apr 2014

Typical duration for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

December 5, 2014

Last Update Submit

April 23, 2018

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Recurrence of atrial arrhythmia

    Any episode of AF/AT \> 30 sec will be considered as a recurrence. Episodes that occur during the first 2 months after the procedure (blanking period) will not be considered as recurrence.

    1 year post-ablation

Secondary Outcomes (2)

  • Procedural complications

    48 hours

  • Acute success

    Intra-procedural

Study Arms (3)

Arm I

ACTIVE COMPARATOR

ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) Intervention: AF ablation

Procedure: radiofrequency catheter ablation

Arm II

ACTIVE COMPARATOR

ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) + conventional pulmonary vein antrum isolation (PVAI) Intervention: AF ablation

Procedure: radiofrequency catheter ablation

Arm III

ACTIVE COMPARATOR

Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial electrograms (CFAE) Intervention: AF ablation

Procedure: radiofrequency catheter ablation

Interventions

radiofrequency catheter ablationPROCEDURE

Radiofrequency catheter ablation of atrial fibrillation with or without being guided by FIRMap (using RhythmView™ Workstation from TOPERA)

Also known as: RFCA
Arm IArm IIArm III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: ≥ 18 years
  • Patients presenting with persistent or long-standing persistent AF
  • Undergoing first ablation procedure
  • Ability to provide written informed consent

You may not qualify if:

  • Reversible causes of atrial arrhythmia such as hyperthyroidism, pneumonia, pulmonary embolism, sarcoidosis and excessive alcohol consumption
  • Prior ablation procedures
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Austin, Texas, 78705, United States

Location

Related Publications (2)

  • Mohanty S, Gianni C, Trivedi C, Metz T, Bai R, Al-Ahmad A, Bailey S, Burkhardt JD, Gallinghouse GJ, Horton R, Hranitzky PM, Sanchez JE, Di Biase L, Natale A. Impact of rotor ablation in non-paroxysmal AF patients: Findings from the per-protocol population of the OASIS trial at long-term follow-up. Am Heart J. 2018 Nov;205:145-148. doi: 10.1016/j.ahj.2018.05.021. Epub 2018 Jul 31.

    PMID: 30144981DERIVED

  • Mohanty S, Gianni C, Mohanty P, Halbfass P, Metz T, Trivedi C, Deneke T, Tomassoni G, Bai R, Al-Ahmad A, Bailey S, Burkhardt JD, Gallinghouse GJ, Horton R, Hranitzky PM, Sanchez JE, Di Biase L, Natale A. Impact of Rotor Ablation in Nonparoxysmal Atrial Fibrillation Patients: Results From the Randomized OASIS Trial. J Am Coll Cardiol. 2016 Jul 19;68(3):274-282. doi: 10.1016/j.jacc.2016.04.015. Epub 2016 May 6.

    PMID: 27163758DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Andrea Natale, MD

    Texas Cardiac Arrhythmia Research Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2014

First Posted

August 27, 2015

Study Start

April 1, 2014

Primary Completion

March 1, 2016

Study Completion

July 1, 2017

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations

US(1)