ArrythmiaPhase 4PIVATALNCT05034432
The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
A Phase 4 study testing Intra-Op Prophylactic VT ablation and Conventional Management in people with Arrythmia and Cardiomyopathies, run by University of Rochester at 19 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia, Cardiomyopathies
- What is being tested?
- Intra-Op Prophylactic VT ablation and Conventional Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 19 sitesUnited States
- Study dates
- 27 May 2022to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kathy Honsinger contact
19 sites in 1 country
United States19 sites, 19 recruiting
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
Megan Kopp, 404-605-5003, megan.kopp@piedmont.org
Ahmadreza Karimianpour
- Recruiting
Emory University
Atlanta, Georgia, 30322
Jovita Brevard, 404-712-5992, jovita.johnson@emory.edu
Anand Shah
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Zyriah Robinson, 443-927-3983, zyriah.robinson@jhmi.edu
Chetan Pasrija
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Juan Carlos Collado Falcon, 617-636-7433, juan.carlos.collado.falcon@tuftsmedicine.org
Guy Rozen
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Hannah Culpepper, 843-792-7244, culpepph@musc.edu
Arman Kilic
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Raquel Rozich, 216-444-4959
Jakub Sroubek
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Briita Wanhala, 313-916-9575, bwanhal1@hfhs.org
Arfaat Khan
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Chinwe Ngumezi, 346-238-0290, ccngumezi@houstonmethodist.org
Nilesh Mathuria
- Recruiting
Ascension St. Vincent Indianapolis
Indianapolis, Indiana, 46260
Regina Margiotti, 317-338-6151, regina.margiotti@ascension.org
Sunit-Preet Chaudhry
- Recruiting
UCLA Cardiac Arrthmia Center
Los Angeles, California, 90095
Julie Sorg, 310-259-7327, jsorg@mednet.ucla.edu
Kalyanam Shivkumar
- Recruiting
Univedrsity of Louisville
Louisville, Kentucky, 40202
Julie Caswell, 502-587-4177, julie.caswell@louisville.edu
Auras Ravi Atreya
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Lisa Slinger, 615-385-2602, lisa.slinger@vumc.org
Sandip Zalawadiya
- Recruiting
Columbia University Medical Center
New York, New York, 10026
Jessica Idumonyi, 212-305-1429, joi2102@cumc.columbia.edu
Nir Uriel
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mary Gnap, 215-349-8446, mary.gnap@pennmedicine.upenn.edu
Greg Supple
- Recruiting
Banner University Medical Center
Phoenix, Arizona, 85006
Matt Freeman, 623-293-3945, mathew.freeman@bannerhealth.com
Roderick Tung
- Recruiting
UPMC
Pittsburgh, Pennsylvania, 15213
Rachel Mcgargle, 412-864-0788, mcgarglerd@upmc.edu
Krishna Kancharla
- Recruiting
University of Rochester
Rochester, New York, 14642
Lori Caufield
Sabu Thomas
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Maria Eleni Varympopioti, 415-910-5046, mariaeleni.varympopioti@ucsf.edu
Joshua Moss
- Recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Jamie Guillergan, 202-877-5902, jamie.s.guillergan@medstar.net
Keki Balsara
About this study
Official title: Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
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
Read the 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.
- Conditions
- Arrythmia, Cardiomyopathies
- Being tested
- Intra-Op Prophylactic VT ablation, Conventional Management
- Medical subject headings
- Arrhythmias, Cardiac, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Op Prophylactic VT ablationProcedure or surgery
For surgical intra-operative ablation, efforts will be made to identify scarred myocardium based on methods such as cardiac magnetic resonance imaging, nuclear scans, and/or echocardiogram. Electrophysiological mapping may be obtained either pre-surgery or intra-operation. Mapping and ablation will be performed with the currently approved and updated mapping and ablation systems available at each center. Voltage mapping of the ventricle(s) to delineate scars will be carried out through electroanatomic mapping
Conventional ManagementOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intra-Op Prophylactic VT ablation | Experimental | 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 Receives: Procedure: Intra-Op Prophylactic VT ablation |
| Conventional Management | Active comparator | 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 Receives: Other: Conventional Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent VTA
Total VTA events, after accounting for the competing risk of death
Measured: Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
Secondary outcomes (5)
Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.
Number of participants with any of the following: hospitalization, stroke or right heart failure. Right heart failure assessed by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria.
Measured: Post LVAD implant until end of follow-up, approximately 18 months
Mean duration of LVAD implant (and ablation) surgery
Measured: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean duration of ablation
Measured: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean rate of peri-procedural complication
Peri-procedural complications include bleeding, infection, and need for repeat operation.
Measured: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean Length of stay in the intensive care unit after LVAD implant
Measured: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start27 May 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David Huang, University of Rochester
- Investigators
- David Huang, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034432
- Sponsor's protocol ID
- STUDY00006159
- Other IDs
- R01HL159401
- Acronym
- PIVATAL
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2021
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oates CP, Lam PH, Lawrence L, Bigham G, Meda NS, Basyal B, Hadadi CA, Rao SD, Hockstein M, Shah M, Sheikh FH. Early Ventricular Arrhythmias After Left Ventricular Assist Device Implantation. J Card Fail. 2024 Aug;30(8):1018-1027. doi: 10.1016/j.cardfail.2023.11.018. Epub 2023 Dec 15.
PubMed 38103723
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
- ClinicalTrials.gov ID
- NCT05034432
- Acronym / sponsor ID
- PIVATAL / STUDY00006159
- Conditions
- Arrythmia, Cardiomyopathies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 May 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Sep 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-Op Prophylactic VT ablation | Experimental | Procedure: Intra-Op Prophylactic VT ablationSubjects 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 |
| Conventional Management | Active comparator | Other: Conventional ManagementTo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Intra-Op Prophylactic VT ablationFor surgical intra-operative ablation, efforts will be made to identify scarred myocardium based on methods such as cardiac magnetic resonance imaging, nuclear scans, and/or echocardiogram. Electrophysiological mapping may be obtained either pre-surgery or intra-operation. Mapping and ablation will be performed with the currently approved and updated mapping and ablation systems available at each center. Voltage mapping of the ventricle(s) to delineate scars will be carried out through electroanatomic mapping | Procedure or surgery | Intra-Op Prophylactic VT ablation |
| Conventional ManagementTo 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 | Other | Conventional Management |
Primary outcome
Recurrent VTA
Time frame: Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
Total VTA events, after accounting for the competing risk of death
5 secondary outcomes
Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.
Time frame: Post LVAD implant until end of follow-up, approximately 18 months
Mean duration of LVAD implant (and ablation) surgery
Time frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean duration of ablation
Time frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean rate of peri-procedural complication
Time frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean Length of stay in the intensive care unit after LVAD implant
Time frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Derived from this study: PubMed 38103723Oates CP, Lam PH, Lawrence L, Bigham G, Meda NS, Basyal B, Hadadi CA, Rao SD, Hockstein M, Shah M, Sheikh FH. Early Ventricular Arrhythmias After Left Ventricular Assist Device Implantation. J Card Fail. 2024 Aug;30(8):1018-1027. doi: 10.1016/j.cardfail.2023.11.018. Epub 2023 Dec 15.
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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.
Kathy Honsinger contact
David Huang, MD principal investigator
University of Rochester
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intra-Op Prophylactic VT ablation and Conventional Management in people with Arrythmia and Cardiomyopathies, run by University of Rochester at 19 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Colasurdo (585-275-1054, ann_colasurdo@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent VTA (time frame: Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 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 NCT05034432, which also lists 1 linked publication.
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 14 Jul 2026.