Ventricular TachycardiaNCT05839873
Abbott Ventricular Tachycardia PAS
An observational study of Ventricular Tachycardia, run by Abbott Medical Devices at 11 sites in United States.
Trial summary
This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- FlexAbility SE Ablation Catheter
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 11 sitesUnited States
- Study dates
- 24 Jul 2023to Nov 2026
- Phase
- Observational
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This clinical investigation will enroll subjects of all genders who have recurrent, drug-refractory, sustained monomorphic ventricular tachycardia in patients with non-ischemic structural heart disease.
Who may be able to join
- Patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure
- Subjects who have recurrent, drug-refractory, sustained MMVT with non-ischemic structural heart disease and a clinical decision has been made to use FlexAbility SE for an ablation procedure prior to enrollment in the research study
- Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT
- Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure
- Able and willing to comply with all study requirements
Who cannot join
- Documented or known intracardiac thrombus or myxoma
- Active systemic infection
- History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure
- Patients with prosthetic valves as the catheter may damage the prosthesis
- Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolinas Medical Center
Charlotte, North Carolina, 28203
Baylor Scott & White Heart & Vascular Hospital
Dallas, Texas, 75226
St. Vincent Hospital
Indianapolis, Indiana, 46240-0970
VA Medical Center Minneapolis
Minneapolis, Minnesota, 55417
NCH Healthcare System
Naples, Florida, 34102
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37232
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, 66211
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
Official title: Abbott Ventricular Tachycardia Post Approval Study
This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.
- Conditions
- Ventricular Tachycardia
- Being tested
- FlexAbility SE Ablation Catheter
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlexAbility SE Ablation CatheterDevice
Subjects receive ablation treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Single Arm Group to receive ablation. Receives: Device: FlexAbility SE Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.
Measured: 12 Month
Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start24 Jul 2023
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Ruffner, PhD, Study director, Clinical Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839873
- Sponsor's protocol ID
- ABT-CIP-10471
- Status last verified
- Oct 2025
- First submitted
- 21 Apr 2023
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbott Ventricular Tachycardia Post Approval Study
- ClinicalTrials.gov ID
- NCT05839873
- Acronym / sponsor ID
- ABT-CIP-10471
- Conditions
- Ventricular Tachycardia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 3 May 2023 (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.
This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: FlexAbility SE Ablation CatheterSingle Arm Group to receive ablation. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This clinical investigation will enroll subjects of all genders who have recurrent, drug-refractory, sustained monomorphic ventricular tachycardia in patients with non-ischemic structural heart disease.
Key inclusion criteria (5 listed)
- Patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure
- Subjects who have recurrent, drug-refractory, sustained MMVT with non-ischemic structural heart disease and a clinical decision has been made to use FlexAbility SE for an ablation procedure prior to enrollment in the research study
- Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT
- Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure
- Able and willing to comply with all study requirements
Key exclusion criteria (5 listed)
- Documented or known intracardiac thrombus or myxoma
- Active systemic infection
- History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure
- Patients with prosthetic valves as the catheter may damage the prosthesis
- Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
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 |
|---|---|---|
| FlexAbility SE Ablation CatheterSubjects receive ablation treatment. | Device | Treatment Group |
Primary outcome
Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.
Time frame: 12 Month
Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation
Time frame: 12 Month
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 20 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
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SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
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. This study is not recruiting at the moment.
Kristin Ruffner, PhD study director
Clinical Program Director
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, run by Abbott Medical Devices at 11 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure. (time frame: 12 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2025.