Persistent Atrial FibrillationPIVoTAL-IDENCT04505163
Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF
A study testing Standard Cryoballoon Pulmonary Vein Isolation (PVI) and Cryoballoon PVI + Posterior Wall Isolation in people with Persistent Atrial Fibrillation, run by Dignity Health Medical Foundation at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Standard Cryoballoon Pulmonary Vein Isolation (PVI) and Cryoballoon PVI + Posterior Wall Isolation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 11 sitesUnited States
- Study dates
- 30 Apr 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Show all 13Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Texas Cardiac Arrhythmia Institute & St. David's Medical Center
Austin, Texas, 78705
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Bethesda North Hospital
Cincinnati, Ohio, 45242
UCHealth Medical Center
Fort Collins, Colorado, 80528
Nebraska Methodist Hospital-Methodist Physicians Clinic
Omaha, Nebraska, 68114
Mercy General Hospital and Dignity Health Medical Foundation
Sacramento, California, 95819
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Tampa Cardiac Specialists
Tampa, Florida, 33558
MedStar Georgetown University Hospital and Medical Center
Washington D.C., District of Columbia, 20007
About this study
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
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.
Read the detailed description
Patients with persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. After catheter ablation (isolation) of the pulmonary veins (PVI) and while still in the cardiac electrophysiology laboratory, all patients will be randomized to either PVI alone or the combination of PVI + posterior left atrial wall isolation (PWI). For patients randomized to PVI, their ablation procedure will be completed at that time. For those patients randomized to PVI + PWI, they will have additional ablation to achieve PWI.
All study patients will have the same follow-up after their ablation procedure, including clinic visits at 3, 6, and 12 months and a heart event monitor for 7-14 days before these visits. An echocardiogram (heart ultrasound) is performed at 6 to 12 months after the ablation. Blood thinners are recommended for two months after ablation and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the decision of the study doctor. Information about the patients' medical history, heart arrhythmias and atrial fibrillation will be collected during the study which will be analyzed.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Standard Cryoballoon Pulmonary Vein Isolation (PVI), Cryoballoon PVI + Posterior Wall Isolation
- Keywords
- Atrial fibrillation, Catheter ablation, Cryoablation, Cryoballoon, Posterior left atrial wall ablation, Pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Cryoballoon Pulmonary Vein Isolation (PVI)Procedure or surgery
Also called Arctic Front Advance Cardiac Cryoablation System
Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone
Cryoballoon PVI + Posterior Wall IsolationDevice
Also called Arctic Front Advance Cardiac Cryoablation System
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Cryoballoon PVI + Posterior Wall Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month freedom from recurrent atrial fibrillation
Number of participants with recurrent atrial fibrillation following catheter ablation
Measured: 12 months
Secondary outcomes (10)
All atrial arrhythmia recurrences
Number of atrial arrhythmia recurrences after the 90-day blanking period
Measured: During a follow-up period of 12 months
Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)
Change in CCS-SAF from baseline to 12 months
Measured: During a follow-up period of 12 months
Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT)
Change in AFEQT from baseline to 12 months
Measured: During a follow-up period of 12 months
Multiple procedure success
Absence of recurrent atrial arrhythmias after one or more ablation procedure(s)
Measured: During a follow-up period of 12 months
Relative reduction in atrial fibrillation burden
Reduction in the burden of atrial fibrillation (in percentage) following catheter ablation
Measured: During a follow-up period of 12 months
Freedom from cardioversion for recurrent atrial arrhythmias
Electrical or pharmacological cardioversion for treatment of recurrent atrial arrhythmias not required
Measured: During a follow-up period of 12 months
Freedom from repeat atrial fibrillation ablation
Repeat ablation for atrial fibrillation
Measured: During a follow-up period of 12 months
Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence
Change in left atrial diameter (in millimeters) following ablation
Measured: During a follow-up period of 12 months
Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence
Change in left atrial ejection fraction (in percentage) following ablation
Measured: During a follow-up period of 12 months
New York Heart Association Functional Class as predictor of atrial fibrillation recurrence
Change in New York Heart Association Functional Class following ablation
Measured: During a follow-up period of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start30 Apr 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dignity Health Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Mercy General Hospital and Dignity Health Medical Foundation, Beth Israel Deaconess Medical Center, UC Health Medical Center, MedStar Georgetown University Hospital, Tampa Cardiac Specialists, Bethesda North Hospital, Brigham and Women's Hospital, Texas Cardiac Arrhythmia Institute At St. Davids Medical Center, St. Luke's Hospital and Health Network, Pennsylvania, Sarasota Memorial Health Care System, Nebraska Methodist Hospital-Methodist Physicians Clinic
- Responsible party
- Principal investigator, Arash Aryana, MD, Dignity Health Medical Foundation
- Investigators
- Arash Aryana, MD, Principal investigator, Mercy General Hospital and Dignity Health Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505163
- Sponsor's protocol ID
- PIVoTAL-IDE
- Acronym
- PIVoTAL-IDE
- Status last verified
- Sep 2023
- First submitted
- 10 Jul 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Aryana A, Pujara DK, Allen SL, Ellis ER, Heath RR, Trivedi AD, Lee SW, O'Neill PG, Bowers MR, Patel DA, Tadros TM, Stevens SM, Espinosa Ginic MA, Makati KJ, Manshadi RK, Manshadi KK, Di Biase L, d'Avila A, Ellenbogen KA, Natale A, Reddy VY. 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) IDE trial. Heart Rhythm. 2026 Aug;23(8):1695-1704. doi: 10.1016/j.hrthm.2025.08.018. Epub 2025 Aug 19.
PubMed 40840576Aryana 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.
PubMed 33009645
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04505163
- Acronym / sponsor ID
- PIVoTAL-IDE / PIVoTAL-IDE
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Atrial fibrillation, Catheter ablation, Cryoablation, Cryoballoon, Posterior left atrial wall ablation, Pulmonary vein isolation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Dignity Health Medical FoundationUniversity, hospital or other
- Collaborators
- Mercy General Hospital and Dignity Health Medical Foundation, Beth Israel Deaconess Medical Center, UC Health Medical Center, MedStar Georgetown University Hospital, Tampa Cardiac Specialists, Bethesda North Hospital, Brigham and Women's Hospital, Texas Cardiac Arrhythmia Institute At St. Davids Medical Center, St. Luke's Hospital and Health Network, Pennsylvania, Sarasota Memorial Health Care System, Nebraska Methodist Hospital-Methodist Physicians Clinic
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. After catheter ablation (isolation) of the pulmonary veins (PVI) and while still in the cardiac electrophysiology laboratory, all patients will be randomized to either PVI alone or the combination of PVI + posterior left atrial wall isolation (PWI). For patients randomized to PVI, their ablation procedure will be completed at that time. For those patients randomized to PVI + PWI, they will have additional ablation to achieve PWI.
All study patients will have the same follow-up after their ablation procedure, including clinic visits at 3, 6, and 12 months and a heart event monitor for 7-14 days before these visits. An echocardiogram (heart ultrasound) is performed at 6 to 12 months after the ablation. Blood thinners are recommended for two months after ablation and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the decision of the study doctor. Information about the patients' medical history, heart arrhythmias and atrial fibrillation will be collected during the study which will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Cryoballoon Pulmonary Vein Isolation (PVI) | Active comparator | Procedure: Standard Cryoballoon Pulmonary Vein Isolation (PVI)Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters |
| Cryoballoon PVI + Posterior Wall Isolation | Experimental | Device: Cryoballoon PVI + Posterior Wall IsolationCryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Cryoballoon Pulmonary Vein Isolation (PVI)Also: Arctic Front Advance Cardiac Cryoablation SystemArctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone | Procedure or surgery | Standard Cryoballoon Pulmonary Vein Isolation (PVI) |
| Cryoballoon PVI + Posterior Wall IsolationAlso: Arctic Front Advance Cardiac Cryoablation SystemArctic 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 | Device | Cryoballoon PVI + Posterior Wall Isolation |
Primary outcome
12-month freedom from recurrent atrial fibrillation
Time frame: 12 months
Number of participants with recurrent atrial fibrillation following catheter ablation
10 secondary outcomes
All atrial arrhythmia recurrences
Time frame: During a follow-up period of 12 months
Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)
Time frame: During a follow-up period of 12 months
Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT)
Time frame: During a follow-up period of 12 months
Multiple procedure success
Time frame: During a follow-up period of 12 months
Relative reduction in atrial fibrillation burden
Time frame: During a follow-up period of 12 months
Freedom from cardioversion for recurrent atrial arrhythmias
Time frame: During a follow-up period of 12 months
Freedom from repeat atrial fibrillation ablation
Time frame: During a follow-up period of 12 months
Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence
Time frame: During a follow-up period of 12 months
Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence
Time frame: During a follow-up period of 12 months
New York Heart Association Functional Class as predictor of atrial fibrillation recurrence
Time frame: During a follow-up period of 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 40840576Aryana A, Pujara DK, Allen SL, Ellis ER, Heath RR, Trivedi AD, Lee SW, O'Neill PG, Bowers MR, Patel DA, Tadros TM, Stevens SM, Espinosa Ginic MA, Makati KJ, Manshadi RK, Manshadi KK, Di Biase L, d'Avila A, Ellenbogen KA, Natale A, Reddy VY. 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) IDE trial. Heart Rhythm. 2026 Aug;23(8):1695-1704. doi: 10.1016/j.hrthm.2025.08.018. Epub 2025 Aug 19.
- Derived from this study: PubMed 33009645Aryana 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arash Aryana, MD principal investigator
Mercy General Hospital and Dignity Health Medical Foundation
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Cryoballoon Pulmonary Vein Isolation (PVI) and Cryoballoon PVI + Posterior Wall Isolation in people with Persistent Atrial Fibrillation, run by Dignity Health Medical Foundation at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month freedom from recurrent atrial fibrillation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04505163, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.