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VT Ablation Before LVAD Surgery for Arrhythmia (PIVATAL Trial)
Phase 4
Recruiting
Led By Mehmet W Aktas, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
Presence of advanced cardiomyopathy (of all INTERMACS classification) and eligible for LVAD implant per the decision of the Heart Failure clinical team
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post lvad implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
Awards & highlights
PIVATAL Trial Summary
This trial is testing whether getting rid of the VTA before LVAD implant surgery can reduce the incidence of VTA afterward.
Who is the study for?
This trial is for adults over 18 with advanced heart muscle disease who are eligible for a heart pump device (LVAD) implant. They must have had or be getting a defibrillator due to past episodes of dangerous heart rhythms within the last 5 years.Check my eligibility
What is being tested?
The study is testing if doing a procedure to prevent irregular heartbeats during LVAD implant surgery can lower the chances of these arrhythmias happening afterward, compared to usual care without this extra procedure.See study design
What are the potential side effects?
Potential side effects may include risks associated with the ablation procedure such as bleeding, infection, and damage to the heart or surrounding structures. There might also be typical surgical risks from LVAD implantation.
PIVATAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
My heart is very weak, and I am approved for a device to help it pump.
Select...
I have had a long-lasting episode of irregular heartbeat in the last 5 years.
PIVATAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post lvad implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post lvad implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrent VTA
Secondary outcome measures
Mean Length of stay in the intensive care unit after LVAD implant
Mean duration of LVAD implant (and ablation) surgery
Mean duration of ablation
+2 morePIVATAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intra-Op Prophylactic VT ablationExperimental Treatment1 Intervention
Subjects will get ablation procedure as needed if they were determined to be refractory to medical antiarrhythmic control should undergo catheter-based electrophysiology study and ablation on LVAD support
Group II: Conventional ManagementActive Control1 Intervention
To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
834 Previous Clinical Trials
518,192 Total Patients Enrolled
2 Trials studying Arrhythmia
150 Patients Enrolled for Arrhythmia
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,657 Total Patients Enrolled
42 Trials studying Arrhythmia
9,608 Patients Enrolled for Arrhythmia
Mehmet W Aktas, MDPrincipal InvestigatorUniversity of Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot or do not want to give permission for treatment.I am older than 18 years.My heart is very weak, and I am approved for a device to help it pump.I have had a long-lasting episode of irregular heartbeat in the last 5 years.You have had a specific type of heart device implanted in the past or are planning to have it implanted during the hospital stay for another heart device.I had a successful VTA ablation before my LVAD implant, with no VTA recurrence.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional Management
- Group 2: Intra-Op Prophylactic VT ablation
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are new participants currently being accepted into this research study?
"This investigation, which was originally made public on May 27th 2022, is still actively seeking individuals to participate. The data posted on clinicaltrials.gov was recently updated in July of the same year."
Answered by AI
What is the cap for enrolment in this clinical experiment?
"That is accurate. According to clinicaltrials.gov, the medical trial posted on May 27th 2022 is currently recruiting participants. The study requires 100 volunteers from a single site and was last updated in July 1st 2022."
Answered by AI
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