Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF

NCT05296824 | Completed Results

• 1 other identifier: IMPPROVE-PAF
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 4

Brief Summary

Cryoballoon ablation has emerged as a safe and effective strategy for treatment of atrial fibrillation (AF) for which it has recently received a 'first-line' therapy indication by the FDA. Pulmonary vein (PV) isolation (PVI) has been the cornerstone of this procedure achieving freedom from recurrent AF in up to \~80% of patients at 12 months of follow-up. However, the success has been shown to be significantly lower, in the range of 50-60% at 3-5 years of follow-up. Other more recent cryoballoon ablation studies have demonstrated marked improvements in clinical outcomes associated with concomitant PVI and cryoballoon ablation/isolation of the 'PV component' (a region of the left atrial posterior \[back\] wall lying between the PVs that is anatomically and embryologically related to the PVs), versus PVI alone in patients with persistent AF. PVI+PWI using cryoballoon ablation has been widely-practiced in patients with paroxysmal AF. However, the acute/long-term safety and efficacy of this approach has not been formally investigated in paroxysmal AF. Given the mechanistic similarities between persistent and paroxysmal AF, the investigators hypothesize that similar benefits associated with PVI+PWI may also be observed in those with paroxysmal AF. Yet, due to the relative infrequency of breakthrough/recurrent arrhythmias in patients with PAF, to detect a significant difference, large sample sizes and extended follow-up (\>24 months) are likely needed. Hence, the aim of this retrospective, observational study is to examine the acute and long-term efficacy and safety beyond 36 months of follow-up associated with PVI alone versus PVI+PWI using cryoballoon ablation in a large cohort of patients with PAF, performed by a single operator between 1/1/2014 and 8/31/2018 at Mercy General Hospital.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Cryoballoon; Pulmonary vein isolation; Posterior wall isolation; Paroxysmal atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Recurrent Atrial Fibrillation

  The recurrence of atrial fibrillation following PVI+PWI versus PVI alone using cryoballoon ablation in patients with symptomatic paroxysmal atrial fibrillation during long-term follow-up greater than 3 years.

  56 months

Secondary Outcomes (1)

• Number of Participants With Recurrence of All Atrial Arrhythmias

  56 months

Study Arms (2)

Pulmonary vein isolation (PVI) only

Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) only

Procedure: Cryoballoon ablation for the treatment of atrial fibrillation

Pulmonary vein isolation (PVI) with posterior wall isolation (PWI)

Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) with posterior wall isolation (PWI)

Procedure: Cryoballoon ablation for the treatment of atrial fibrillation

Interventions

Cryoballoon ablation for the treatment of atrial fibrillation PROCEDURE

Cryoballoon ablation for the treatment of atrial fibrillation

Pulmonary vein isolation (PVI) only; Pulmonary vein isolation (PVI) with posterior wall isolation (PWI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with symptomatic paroxysmal atrial fibrillation

You may qualify if:

• Age 18 years or older
• Cryoballoon PVI+PWI
• Cryoballoon PVI alone
• Symptomatic paroxysmal atrial fibrillation

You may not qualify if:

• None

Sponsors & Collaborators

• Sacramento EP Research: lead
• Mercy General Hospital and Dignity Health Heart and Vascular Institute: collaborator
• UC Health Medical Center: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (4)

Mercy General Hospital and Dignity Health Heart and Vascular Institute

Sacramento, California, 95819, United States

Location

UC Health Medical Center

Loveland, Colorado, 80538, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Nonrandomized analysis despite extensive cohort matching may have confounded either treatment arm; PVI used during initial study phase \& later PVI+PWI was used; Follow-up ambulatory ECG monitoring may have failed to detect asymptomatic atrial arrhythmia recurrences; use of implantable cardiac devices vs continuous monitoring; Asymptomatic expressions of certain complications (e.g., esophageal lesions or PV stenosis) could not be entirely excluded as routine diagnostic tests were not performed.

Results Point of Contact

• Title: Arash Aryana, MD, PhD
• Organization: SacEP Research

a_aryana@outlook.com

916-453-2684

Study Officials

• Arash Aryana, MD, PhD

  Mercy General Hospital and Dignity Health Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Greater Sacramento Cardiovascular Service Line

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: January 1, 2014
• Primary Completion: August 31, 2018
• Study Completion: December 31, 2021
• Last Updated: November 5, 2025
• Results First Posted: November 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)