Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF
Public ClinicalTrials.gov record NCT04505163. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) - IDE Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04505163
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Interventions
- Standard Cryoballoon Pulmonary Vein Isolation (PVI) Procedure
- Cryoballoon PVI + Posterior Wall Isolation Device
Procedure · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 29, 2021
- Primary completion
- Apr 29, 2024
- Completion
- Dec 30, 2024
- Last update posted
- Sep 5, 2023
2021 – 2024
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mercy General Hospital and Dignity Health Medical Foundation | Sacramento | California | 95819 | — |
| UCHealth Medical Center | Fort Collins | Colorado | 80528 | — |
| MedStar Georgetown University Hospital and Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Sarasota Memorial Health Care System | Sarasota | Florida | 34239 | — |
| Tampa Cardiac Specialists | Tampa | Florida | 33558 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Nebraska Methodist Hospital-Methodist Physicians Clinic | Omaha | Nebraska | 68114 | — |
| Bethesda North Hospital | Cincinnati | Ohio | 45242 | — |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | — |
| Texas Cardiac Arrhythmia Institute & St. David's Medical Center | Austin | Texas | 78705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04505163, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 5, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04505163 live on ClinicalTrials.gov.