Clinical trial NCT05034432: The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
Official title: Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Arrythmia
Cardiomyopathies
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery

Detailed description: This study is a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA who will be randomized in a 1:1 ratio to intra-operative VTA ablation vs. conventional medical management. Comprehensive data on arrhythmia history, medication history will be collected in all randomized subjects. Antiarrhythmic medical therapy will be handled in a uniform pattern between the two arms. Randomized subjects will then be followed per routine schedules for post LVAD implant. Arrhythmia data, ICD therapy, additional procedures including repeat surgery, ramp echocardiographic tests, right heart catheterization and catheter-based VTA ablation will be collected. In addition, adverse events such as unplanned hospitalizations, emergency department visits, clinic visits, and all other aspects of health care utilization will be gathered. The planned average follow-up period will be 18 months.

Eligibility criteria: Inclusion Criteria:

* 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
* Implanted cardioverter defibrillator (ICD) any time in past with remote monitoring or planned to undergo ICD (or ICM as an alternative, if an ICD cannot be implanted for a clinical reason) implant within the index hospitalization for LVAD implant
* History of treated or monitored sustained (i.e., \>30 seconds in duration ) VT or VF episode within the past 5 years.

Exclusion Criteria:

* Past successful VTA ablation without recurrent VTA prior to LVAD implant (Patients who continue to experience VTA post ablation and pre LVAD implant qualify to be enrolled)
* Participation in other clinical trials (observational registries are allowed with approval)
* Unable or unwilling to provide informed consent

Primary outcomes:
measure: Recurrent VTA
timeFrame: Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.
timeFrame: Post LVAD implant until end of follow-up, approximately 18 months
measure: Mean duration of LVAD implant (and ablation) surgery
timeFrame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
measure: Mean duration of ablation
timeFrame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
measure: Mean rate of peri-procedural complication
timeFrame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
measure: Mean Length of stay in the intensive care unit after LVAD implant
timeFrame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: David Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: