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Cryotherapy
Cryoballoon Ablation for Persistent Atrial Fibrillation (PIVoTAL-IDE Trial)
N/A
Waitlist Available
Led By Arash Aryana, MD
Research Sponsored by Dignity Health Medical Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have symptomatic Persistent AF refractory or intolerant to at least one class I or class III antiarrhythmic drug
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
PIVoTAL-IDE Trial Summary
This trial will compare the recurrence of atrial fibrillation at 12 months after ablation in patients who receive PVI + PWI to those who receive PVI alone.
Who is the study for?
This trial is for adults over 18 with persistent atrial fibrillation (AF) that lasts more than 7 days and hasn't improved with certain medications. Candidates should be undergoing their first catheter ablation, but prior treatment for a different heart rhythm issue is okay. People can't join if they have long-standing AF, reversible causes of AF, recent serious cardiovascular events, specific heart diseases or conditions, severe heart failure, a very large left atrium, blood clots in the heart, pregnancy or life expectancy less than one year.Check my eligibility
What is being tested?
The study tests if doing two procedures together—freezing to isolate pulmonary veins (PVI) and the back wall of the left upper chamber of the heart (PWI)—is better at preventing AF from coming back after one year compared to just PVI alone.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site where catheters are inserted, bruising or bleeding there as well. There's also a risk of damage to surrounding structures in the heart during ablation which could lead to other complications.
PIVoTAL-IDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have AFib symptoms that didn't improve with at least one heart rhythm medication.
PIVoTAL-IDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12-month freedom from recurrent atrial fibrillation
Secondary outcome measures
All atrial arrhythmia recurrences
Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT)
Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)
+7 morePIVoTAL-IDE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cryoballoon PVI + Posterior Wall IsolationExperimental Treatment1 Intervention
Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters
Group II: Standard Cryoballoon Pulmonary Vein Isolation (PVI)Active Control1 Intervention
Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters
Find a Location
Who is running the clinical trial?
Sarasota Memorial Health Care SystemOTHER
Nebraska Methodist Hospital-Methodist Physicians ClinicUNKNOWN
Dignity Health Medical FoundationLead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of thickened heart muscles.I have had a continuous episode of AFib lasting more than 7 days.I am over 18 and having my first catheter ablation for AF; I may have had a previous ablation for a different heart rhythm issue.I have not had a stroke, heart attack, or severe chest pain in the last 2 months.I have AFib symptoms that didn't improve with at least one heart rhythm medication.You must have had a documented episode of atrial fibrillation lasting more than 7 days in the year before the procedure.I have severe heart failure.I am able to understand and consent to the trial.My heart's pumping ability is significantly reduced.I have a heart condition I was born with, whether treated or not.You are pregnant or had a positive pregnancy test within the past week.My atrial fibrillation is caused by a treatable condition.I have had atrial fibrillation for a long time.Your left atrial diameter is larger than 55 millimeters when measured from a specific view during an echocardiogram.I have a blood clot in the left side of my heart.I have had a procedure to correct heart rhythm problems on the left side of my heart.You are not expected to live for more than a year.
Research Study Groups:
This trial has the following groups:- Group 1: Cryoballoon PVI + Posterior Wall Isolation
- Group 2: Standard Cryoballoon Pulmonary Vein Isolation (PVI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being admitted to this scientific experiment?
"Affirmative. The data hosted on clinicaltrials.gov indicates that this medical research is currently seeking participants, with the initial post dating to April 30th 2021 and the most recent edit occurring September 26th 2022. To date, 366 patients have been recruited from 15 sites."
Answered by AI
How many clinical sites have been designated to conduct this trial?
"This medical trial is recruiting in 15 cities, including Stanford University Medical Center (Stanford), Staten Island University Hospital(Staten Island) and the University of California, Davis Medical Centre (Sacramento). The other 12 sites can be found on clinicialtrials.gov."
Answered by AI
Are physicians currently enlisting participants for this research?
"According to the data found on clinicaltrials.gov, this medical trial is actively recruiting for participants as of October 2020. The initial post was made in April 2021 and the last update happened in September 2022."
Answered by AI
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