Recruiting

Ablation Techniques

Sponsor:

Sequoia Hospital

Code:

NCT03295422

Conditions

Chronic Atrial Fibrillation

Persistent Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RF ablation PVI alone

RF ablation PVI plus LPAW

Study Details

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

Conditions

Chronic Atrial Fibrillation

Persistent Atrial Fibrillation

Study ID

NCT03295422

Start date

Aug 25, 2017

Status verified date

Nov, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: RF ablation PVI alone

RF catheter ablation of pulmonary veins alone

experimental: RF ablation PVI plus LPAW

RF catheter ablation PVI plus left atrial posterior wall

Interventions

RF ablation PVI alone

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.

RF ablation PVI plus LPAW

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.

Primary outcome measure

  • 1-year freedom from recurrent atrial arrhythmias [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Christopher E Woods, MD, PhD

650-652-8600WoodC@sutterhealth.org

Ann Campbell, RN, MBA

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

Locations

Dignity Health, Sequoia Hospital

Recruiting

Redwood City, California, United States, 94062

Contacts

Christopher E Woods, MD, PhD

650-652-8600woodsC@sutterhealth.org

Ann Campbell, RN, MBA

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

Principal Investigator:

Christopher E Woods, MD, PhD

More Information

Sponsor

Sequoia Hospital

Last update posted

Nov 19, 2020

Last verified

Nov, 2020

Keywords

  • Persistent Atrial Fibrillation
  • Radiofrequency ablation
  • Catheter ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sequoia Hospital on 2020-11-19.