Who is sponsoring NCT04505163?

NCT04505163 is sponsored by Dignity Health Medical Foundation.

What drugs are being tested in NCT04505163?

Interventions in NCT04505163: Standard Cryoballoon Pulmonary Vein Isolation (PVI), Cryoballoon PVI + Posterior Wall Isolation.

What condition does NCT04505163 study?

NCT04505163 studies Persistent Atrial Fibrillation.

Is NCT04505163 still recruiting?

NCT04505163 is currently status unknown. Last updated 6 September 2023.

Last reviewed 2023-09-06 · How we verify

NCT04505163: PIVoTAL-IDE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF

Status unknown NA Last updated 6 September 2023

What this trial tests

NA trial testing Standard Cryoballoon Pulmonary Vein Isolation (PVI) in Persistent Atrial Fibrillation in 153 participants. Status unknown.

Timeline

30 April 2021

Primary endpoint
30 April 2024

31 December 2024

Quick facts

Lead sponsor	Dignity Health Medical Foundation
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	153
Start date	30 April 2021
Primary completion	30 April 2024
Estimated completion	31 December 2024
Sites	11 locations across United States

Drugs / interventions tested

Standard Cryoballoon Pulmonary Vein Isolation (PVI)
Cryoballoon PVI + Posterior Wall Isolation

Conditions studied

Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →

Sponsor

Dignity Health Medical Foundation

Who can join

18 and older, any sex, with Persistent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design.
Aryana A, Pujara DK, Allen SL, Baker JH, et al · · 2021 · cited 15× · PMID 33009645 · DOI 10.1007/s10840-020-00885-w
Rationale and Outcomes of Cryoballoon Ablation of the Left Atrial Posterior Wall in Conjunction with Pulmonary Vein Isolation.
Aryana A. · · 2021 · cited 4× · PMID 34476116 · DOI 10.19102/icrm.2021.120801
The Value of Adjunctive Left Atrial Posterior Wall Isolation on Clinical Outcomes in Atrial Fibrillation Patients: A Systematic Review and Meta-Analysis.
Liu L, Geng Y, Liu Y, Lv T, et al · · 2024 · cited 1× · PMID 39076330 · DOI 10.31083/j.rcm2506210
Concomitant cryoballoon pulmonary vein and posterior wall isolation in persistent atrial fibrillation: Results from the Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL
Aryana A, Pujara DK, Allen SL, Ellis ER, et al · · 2025 · PMID 40840576 · DOI 10.1016/j.hrthm.2025.08.018

Verify or expand the search:

Other recruiting trials for Persistent Atrial Fibrillation

Currently open trials in the same condition.

NCT07298473 — Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sp · NA · recruiting
NCT07535268 — REPRESENT-PF Registry · recruiting
NCT07508618 — Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule · Phase 4 · recruiting
NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
NCT07106970 — PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II) · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04505163 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dignity Health Medical Foundation
Last refreshed: 6 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04505163.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing