NCT04505163

Brief Summary

The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone. The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.

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
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

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

First Submitted

Initial submission to the registry

July 10, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

April 30, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

July 10, 2020

Last Update Submit

September 1, 2023

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial fibrillationCatheter ablationCryoablationCryoballoonPosterior left atrial wall ablationPulmonary vein isolation

Outcome Measures

Primary Outcomes (1)

  • 12-month freedom from recurrent atrial fibrillation

    Number of participants with recurrent atrial fibrillation following catheter ablation

    12 months

Secondary Outcomes (10)

  • All atrial arrhythmia recurrences

    During a follow-up period of 12 months

  • Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)

    During a follow-up period of 12 months

  • Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT)

    During a follow-up period of 12 months

  • Multiple procedure success

    During a follow-up period of 12 months

  • Relative reduction in atrial fibrillation burden

    During a follow-up period of 12 months

  • +5 more secondary outcomes

Study Arms (2)

Standard Cryoballoon Pulmonary Vein Isolation (PVI)

ACTIVE COMPARATOR

Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters

Procedure: Standard Cryoballoon Pulmonary Vein Isolation (PVI)

Cryoballoon PVI + Posterior Wall Isolation

EXPERIMENTAL

Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters

Device: Cryoballoon PVI + Posterior Wall Isolation

Interventions

Standard Cryoballoon Pulmonary Vein Isolation (PVI)PROCEDURE

Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone

Also known as: Arctic Front Advance Cardiac Cryoablation System
Standard Cryoballoon Pulmonary Vein Isolation (PVI)
Cryoballoon PVI + Posterior Wall IsolationDEVICE

Arctic Front Advance Cardiac Cryoballoon Ablation System to ablate the pulmonary veins and the left atrial posterior wall to achieve PVI + posterior wall isolation within the region of the pulmonary venous component

Also known as: Arctic Front Advance Cardiac Cryoablation System
Cryoballoon PVI + Posterior Wall Isolation

Eligibility Criteria

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

You may qualify if:

  • Consistent with the current definitions, all patients with Persistent AF must exhibit an episode of continuous AF that is sustained \>7 days.
  • Patients must have symptomatic Persistent AF refractory or intolerant to at least one class I or class III antiarrhythmic drug
  • Males and females with an age \>18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted
  • All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements
  • Patients must have documented episode of AF greater than 7 days in the year prior to the procedure

You may not qualify if:

  • History of long-standing persistent AF
  • Any reversible cause of AF (post-operative, thyroid disorder, etc.)
  • Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
  • Patients with any corrected or uncorrected congenital heart disease
  • Patients with a history of hypertrophic cardiomyopathy
  • Patients with cardiomyopathy and a left ventricular ejection fraction \<40%
  • Congestive heart failure, class IV
  • Left atrial (LA) diameter \>55 mm (parasternal long axis view)
  • Patients with left atrial thrombus
  • Women who are known to be pregnant or have had a positive β-HCG (human chorionic gonadotropin) test 7 days prior to procedure
  • Patients whose life expectancy is \<1 year
  • History of left-sided left atrial ablation (catheter or surgically-based)
  • Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Mercy General Hospital and Dignity Health Medical Foundation

Sacramento, California, 95819, United States

Location

UCHealth Medical Center

Fort Collins, Colorado, 80528, United States

Location

MedStar Georgetown University Hospital and Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Tampa Cardiac Specialists

Tampa, Florida, 33558, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Nebraska Methodist Hospital-Methodist Physicians Clinic

Omaha, Nebraska, 68114, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Texas Cardiac Arrhythmia Institute & St. David's Medical Center

Austin, Texas, 78705, United States

Location

Related Publications (1)

  • Aryana A, Pujara DK, Allen SL, Baker JH, Espinosa MA, Buch EF, Srivatsa U, Ellis E, Makati K, Kowalski M, Lee S, Tadros T, Baykaner T, Al-Ahmad A, d'Avila A, Di Biase L, Okishige K, Natale A. Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design. J Interv Card Electrophysiol. 2021 Oct;62(1):187-198. doi: 10.1007/s10840-020-00885-w. Epub 2020 Oct 3.

    PMID: 33009645DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arash Aryana, MD

    Mercy General Hospital and Dignity Health Medical Foundation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 10, 2020

First Posted

August 10, 2020

Study Start

April 30, 2021

Primary Completion

April 30, 2024

Study Completion

December 31, 2024

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(11)