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Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF (PIVoTAL-IDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04505163
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : February 9, 2022
Sponsor:
Collaborators:
Mercy General Hospital and Dignity Health Medical Foundation
Stanford University
Beth Israel Deaconess Medical Center
UC Health Medical Center
MedStar Georgetown University Hospital and Medical Center
Tampa Cardiac Specialists
Bethesda North Hospital
Brigham and Women's Hospital
Ohio Health Physician Group
Texas Cardiac Arrhythmia Institute At St. Davids Medical Center
St. Luke's Hospital and Health Network, Pennsylvania
University of California, Davis
Information provided by (Responsible Party):
Dignity Health Medical Foundation

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.


Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Standard Cryoballoon Pulmonary Vein Isolation (PVI) Device: Cryoballoon PVI + Posterior Wall Isolation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Cryoballoon Pulmonary Vein Isolation (PVI)
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)
Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone
Other Name: Arctic Front Advance Cardiac Cryoablation System

Experimental: Cryoballoon PVI + Posterior Wall Isolation
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
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
Other Name: Arctic Front Advance Cardiac Cryoablation System




Primary Outcome Measures :
  1. 12-month freedom from recurrent atrial fibrillation [ Time Frame: 12 months ]
    Number of participants with recurrent atrial fibrillation following catheter ablation


Secondary Outcome Measures :
  1. All atrial arrhythmia recurrences [ Time Frame: During a follow-up period of 12 months ]
    Number of atrial arrhythmia recurrences after the 90-day blanking period

  2. Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF) [ Time Frame: During a follow-up period of 12 months ]
    Change in CCS-SAF from baseline to 12 months

  3. Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) [ Time Frame: During a follow-up period of 12 months ]
    Change in AFEQT from baseline to 12 months

  4. Multiple procedure success [ Time Frame: During a follow-up period of 12 months ]
    Absence of recurrent atrial arrhythmias after one or more ablation procedure(s)

  5. Relative reduction in atrial fibrillation burden [ Time Frame: During a follow-up period of 12 months ]
    Reduction in the burden of atrial fibrillation (in percentage) following catheter ablation

  6. Freedom from cardioversion for recurrent atrial arrhythmias [ Time Frame: During a follow-up period of 12 months ]
    Electrical or pharmacological cardioversion for treatment of recurrent atrial arrhythmias not required

  7. Freedom from repeat atrial fibrillation ablation [ Time Frame: During a follow-up period of 12 months ]
    Repeat ablation for atrial fibrillation

  8. Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence [ Time Frame: During a follow-up period of 12 months ]
    Change in left atrial diameter (in millimeters) following ablation

  9. Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence [ Time Frame: During a follow-up period of 12 months ]
    Change in left atrial ejection fraction (in percentage) following ablation

  10. New York Heart Association Functional Class as predictor of atrial fibrillation recurrence [ Time Frame: During a follow-up period of 12 months ]
    Change in New York Heart Association Functional Class following ablation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 >48 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505163


Contacts
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Contact: Arash Aryana, MD 916-453-2684 arash.aryana@dignityhealth.org
Contact: Shelley Allen, RN 916-453-2626 shelley.allen@dignityhealth.org

Locations
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United States, California
Mercy General Hospital and Dignity Health Medical Foundation Recruiting
Sacramento, California, United States, 95819
Contact: Arash Aryana, MD    916-453-2684    arash.aryana@dignityhealth.org   
Contact: Shelley Allen, RN    9164532626    shelley.allen@dignityhealth.org   
Sub-Investigator: Mark R. Bowers, MD         
Sub-Investigator: Padraig G. O'Neill, MD         
Stanford University Medical Center Not yet recruiting
Stanford, California, United States, 94305
Contact: Sanjiv Narayan, MD       sanjiv1@stanford.edu   
United States, Colorado
UCHealth Medical Center Not yet recruiting
Fort Collins, Colorado, United States, 80528
Contact: Ethan Ellis, MD       ethan.ellis@uchealth.org   
United States, District of Columbia
MedStar Georgetown University Hospital and Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Sung Lee, MD       Sung.W.Lee@medstar.net   
Sub-Investigator: Sarfraz A Durrani, MD         
United States, Florida
Tampa Cardiac Specialists Recruiting
Tampa, Florida, United States, 33558
Contact: Kevin Makati, MD       kmakati@tampacardiac.com   
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Thomas Tadros, MD       thtadros@gmail.com   
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Andre d'Avila, MD       andredavila@me.com   
United States, Ohio
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Dilesh Patel, MD    248-961-4863    dilesh_patel@trihealth.com   
Sub-Investigator: Marshall Winner, MD         
Sub-Investigator: Hemal Shah, MD         
Ohio Health Physician Group Not yet recruiting
Columbus, Ohio, United States, 43214
Contact: Anish K Amin, MD    614-262-6772    anishamin@gmail.com   
Sub-Investigator: Jaret Tyler, MD         
United States, Pennsylvania
St. Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Steven M Stevens, MD    484-526-7843    steven.stevens@sluhn.org   
Sub-Investigator: Sudip Nanda, MD         
United States, Texas
Texas Cardiac Arrhythmia Institute & St. David's Medical Center Recruiting
Austin, Texas, United States, 78705
Contact: Andrea Natale, MD       Andrea.Natale@stdavids.com   
Sub-Investigator: David Kessler, MD         
Sub-Investigator: Jeffrey Whitehill, MD         
Sponsors and Collaborators
Dignity Health Medical Foundation
Mercy General Hospital and Dignity Health Medical Foundation
Stanford University
Beth Israel Deaconess Medical Center
UC Health Medical Center
MedStar Georgetown University Hospital and Medical Center
Tampa Cardiac Specialists
Bethesda North Hospital
Brigham and Women's Hospital
Ohio Health Physician Group
Texas Cardiac Arrhythmia Institute At St. Davids Medical Center
St. Luke's Hospital and Health Network, Pennsylvania
University of California, Davis
Investigators
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Principal Investigator: Arash Aryana, MD Mercy General Hospital and Dignity Health Medical Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dignity Health Medical Foundation
ClinicalTrials.gov Identifier: NCT04505163    
Other Study ID Numbers: PIVoTAL-IDE
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Dignity Health Medical Foundation:
Atrial fibrillation
Catheter ablation
Cryoablation
Cryoballoon
Posterior left atrial wall ablation
Pulmonary vein isolation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes