NCT03295422

Brief Summary

Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation protocols currently performed in the electrophysiology lab, but have not been studied prospectively to identify which, if either technique, is superior for individuals with persistent atrial fibrillation (AF). Two-hundred subjects will be consecutively enrolled and randomized to either pulmonary vein isolation only or pulmonary vein isolation plus posterior left atrial wall isolation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 25, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

4.4 years

First QC Date

September 24, 2017

Last Update Submit

November 18, 2020

Conditions

Chronic Atrial FibrillationPersistent Atrial Fibrillation

Keywords

Persistent Atrial FibrillationRadiofrequency ablationCatheter ablation

Outcome Measures

Primary Outcomes (1)

  • 1-year freedom from recurrent atrial arrhythmias

    The primary hypotheses that PVI+PI will lead to a greater percentage of patients free from atrial arrhythmias after single ablation procedures than PVI alone.

    1 Year

Study Arms (2)

RF ablation PVI alone

ACTIVE COMPARATOR

RF catheter ablation of pulmonary veins alone

Procedure: RF ablation PVI alone

RF ablation PVI plus LPAW

EXPERIMENTAL

RF catheter ablation PVI plus left atrial posterior wall

Procedure: RF ablation PVI plus LPAW

Interventions

RF ablation PVI alonePROCEDURE

A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins.

Also known as: Catheter ablation of the pulmonary veins
RF ablation PVI alone
RF ablation PVI plus LPAWPROCEDURE

A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins. In addition, a roof and posterior line will be placed in the left atrium to achieve entrance and exit block on the posterior wall. Entry block will be confirmed by placing a circular mapping catheter in multiple locations along the posterior wall and confirming lack of presence of any local potentials. Exit block will be confirmed on the posterior wall with pacing at 10 amps from the ablation catheter at multiple locations within the box as well as all lines.

Also known as: Catheter ablation of the pulmonary veins plus posterior wall
RF ablation PVI plus LPAW

Eligibility Criteria

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

You may qualify if:

  • Have symptomatic persistent AF (i.e., a sustained episode lasting more than 7 days).
  • Refractory to at least one antiarrhythmic agent.
  • Undergoing ablation for the first time.

You may not qualify if:

  • Paroxysmal AF
  • Sustained atrial fibrillation lasting more than 3 years
  • Left atrial diameter of 60 mm or greater

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dignity Health, Sequoia Hospital

Redwood City, California, 94062, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher E Woods, MD, PhD

    Dignity Health, Sequoia Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher E Woods, MD, PhD

CONTACT

650-652-8600WoodC@sutterhealth.org

Ann Campbell, RN, MBA

CONTACT

650-367-5950ann.campbell@dignityhealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

September 24, 2017

First Posted

September 27, 2017

Study Start

August 25, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)