Ventricular TachycardiaPhase 3VISTANCT01045668
Ablation of Clinical Ventricular Tachycardia Versus Addition of Substrate Ablation on the Long Term Success Rate of VT Ablation
A Phase 3 study testing Radiofrequency Catheter Ablation (RFCA) in people with Ventricular Tachycardia, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial summary
This study aims to assess whether a combined technique of substrate ablation and ablation of the clinically presenting VT at the site of early activation is superior to ablation of the clinically presenting VT alone, in enhancing long-term success of VT ablation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Radiofrequency Catheter Ablation (RFCA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous Myocardial infarction
- Symptomatic, drug-refractory and haemodynamically stable VT following CAD
- Undergoing a VT ablation
- Implanted ICD
Who cannot join
- Documented valvular heart disease
- Acute myocardial infarction within the preceding 1 month
- Unstable angina
- Prolonged QT interval
- Patients with hemorrhagic or thrombophilic disorders
- Documented intra-atrial thrombus, tumor or other conditions which prevent easy catheter introduction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Ablation of the Clinically Presenting Ventricular Tachycardia (VT) Only Versus the Addition of Substrate Ablation Based on Scar Mapping; on the Long Term Success Rate of VT Ablation
This study aims to assess whether a combined technique of substrate ablation and ablation of the clinically presenting VT at the site of early activation is superior to ablation of the clinically presenting VT alone, in enhancing long-term success of VT ablation.
Read the detailed description
Background: VT is found mostly in patients with structural heart disease. It is classified using morphological criteria (monomorphic or polymorphic), duration of arrhythmia (sustained or non-sustained) or the mechanism of arrhythmia formation (re-entry, increased automation or triggered activity). The therapeutic approach and prognostic estimates of these different types of VT depend to a great degree on the mechanistic basis of the disease as well as the extent of myocardial damage and success of the therapy is measured by the absence of recurrence.
Myocardial infarction with subsequent induction of VT is observed as a consequence of coronary artery disease (CAD). The infarct regions that are morphologically and electrically diseased can be arrhythmogenic and may form the substrate for macro-reentrant VT.
Although antiarrhythmic drugs remain the primary form of therapy for VT, non-pharmacologic techniques like implantable cardioverter-defibrillator (ICD) and catheter ablation (CA) are becoming increasingly popular because of advancement in technology as well as an increase in desire among patients to eliminate the arrhythmia with ablation rather than suppressing it with drugs. ICDs and CA effectively terminate VT on a short-term basis; but multiple morphologies, hemodynamic instability and non-inducibility limit the long-term success rate of CA. The 'substrate mapping' approach defines areas of ventricular scar which can be potential VT sources. Several studies on small groups of patients have shown that successful ablation of VT substrates either reduces the recurrence of VT to 19- 50% or reduces the frequency of recurrence as well as the requirement of anti-arrhythmic drugs (AADs).
Study design:
This study is a multicenter, randomized, open label, parallel-arm clinical trial. A total of 120 post-myocardial infarction patients will be randomized at a 1:1 ratio into 2 groups:
- ablation targeting the clinically presenting VT at the site of early activation only, or
- ablation targeting the clinically presenting VT at the site of early activation plus substrate-based RF ablation
Follow-up:
Patients will undergo ICD interrogation at 3, 6 and 12 months to collect VT episode data, VT symptom assessment, complication assessment and AAD records. Management of AADs will be at the discretion of the physician.
- Conditions
- Ventricular Tachycardia
- Being tested
- Radiofrequency Catheter Ablation (RFCA)
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Catheter Ablation (RFCA)Procedure or surgery
RFCA of clinical VT
Radiofrequency Catheter Ablation (RFCA)Procedure or surgery
RFCA of clinical VT as well as VT substrates
| Study group | Role | What they receive |
|---|---|---|
| Clinical VT ablation | Active comparator | Not described Receives: Procedure: Radiofrequency Catheter Ablation (RFCA) |
| clinical VT and substrate ablation | Active comparator | Not described Receives: Procedure: Radiofrequency Catheter Ablation (RFCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of any sustained VT in the post-ablation period as demonstrated by electronic documentation Procedural complications associated with prolonged use of radiofrequency (RF) energy such as perforation, cardiac tamponade
Measured: 48 hours
Secondary outcomes (1)
Severe clinical events (hospital admissions for a cardiac cause, syncopal attacks, number of episodes of VT storms, death) Number of ICD interventions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completionJul 2014
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 Ventricular TachycardiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas, California Pacific Medical Center, Stanford University, Case Western Reserve University, Southlake Health, Catholic University, Italy, Ospedale dell'Angelo, Venezia-Mestre, RCCS Monzino Hospital, Milan, Italy, University of Rome Tor Vergata
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Andrea Natale, MD FACC FHRS, Principal investigator, TCAI, St.David's Medical Center, Austin, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045668
- Sponsor's protocol ID
- TCAI-VISTA
- Acronym
- VISTA
- Status last verified
- Aug 2014
- First submitted
- 8 Jan 2010
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Di Biase L, Burkhardt JD, Lakkireddy D, Carbucicchio C, Mohanty S, Mohanty P, Trivedi C, Santangeli P, Bai R, Forleo G, Horton R, Bailey S, Sanchez J, Al-Ahmad A, Hranitzky P, Gallinghouse GJ, Pelargonio G, Hongo RH, Beheiry S, Hao SC, Reddy M, Rossillo A, Themistoclakis S, Dello Russo A, Casella M, Tondo C, Natale A. Ablation of Stable VTs Versus Substrate Ablation in Ischemic Cardiomyopathy: The VISTA Randomized Multicenter Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2872-2882. doi: 10.1016/j.jacc.2015.10.026.
PubMed 26718674
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Ablation of the Clinically Presenting Ventricular Tachycardia (VT) Only Versus the Addition of Substrate Ablation Based on Scar Mapping; on the Long Term Success Rate of VT Ablation
- ClinicalTrials.gov ID
- NCT01045668
- Acronym / sponsor ID
- VISTA / TCAI-VISTA
- Conditions
- Ventricular Tachycardia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Collaborators
- University of Kansas, California Pacific Medical Center, Stanford University, Case Western Reserve University, Southlake Health, Catholic University, Italy, Ospedale dell'Angelo, Venezia-Mestre, RCCS Monzino Hospital, Milan, Italy, University of Rome Tor Vergata
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Jan 2010 (estimated)
- 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 study aims to assess whether a combined technique of substrate ablation and ablation of the clinically presenting VT at the site of early activation is superior to ablation of the clinically presenting VT alone, in enhancing long-term success of VT ablation.
Detailed description
Background: VT is found mostly in patients with structural heart disease. It is classified using morphological criteria (monomorphic or polymorphic), duration of arrhythmia (sustained or non-sustained) or the mechanism of arrhythmia formation (re-entry, increased automation or triggered activity). The therapeutic approach and prognostic estimates of these different types of VT depend to a great degree on the mechanistic basis of the disease as well as the extent of myocardial damage and success of the therapy is measured by the absence of recurrence.
Myocardial infarction with subsequent induction of VT is observed as a consequence of coronary artery disease (CAD). The infarct regions that are morphologically and electrically diseased can be arrhythmogenic and may form the substrate for macro-reentrant VT.
Although antiarrhythmic drugs remain the primary form of therapy for VT, non-pharmacologic techniques like implantable cardioverter-defibrillator (ICD) and catheter ablation (CA) are becoming increasingly popular because of advancement in technology as well as an increase in desire among patients to eliminate the arrhythmia with ablation rather than suppressing it with drugs. ICDs and CA effectively terminate VT on a short-term basis; but multiple morphologies, hemodynamic instability and non-inducibility limit the long-term success rate of CA. The 'substrate mapping' approach defines areas of ventricular scar which can be potential VT sources. Several studies on small groups of patients have shown that successful ablation of VT substrates either reduces the recurrence of VT to 19- 50% or reduces the frequency of recurrence as well as the requirement of anti-arrhythmic drugs (AADs).
Study design:
This study is a multicenter, randomized, open label, parallel-arm clinical trial. A total of 120 post-myocardial infarction patients will be randomized at a 1:1 ratio into 2 groups:
- ablation targeting the clinically presenting VT at the site of early activation only, or
- ablation targeting the clinically presenting VT at the site of early activation plus substrate-based RF ablation
Follow-up:
Patients will undergo ICD interrogation at 3, 6 and 12 months to collect VT episode data, VT symptom assessment, complication assessment and AAD records. Management of AADs will be at the discretion of the physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical VT ablation | Active comparator | Procedure: Radiofrequency Catheter Ablation (RFCA) |
| clinical VT and substrate ablation | Active comparator | Procedure: Radiofrequency Catheter Ablation (RFCA) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previous Myocardial infarction
- Symptomatic, drug-refractory and haemodynamically stable VT following CAD
- Undergoing a VT ablation
- Implanted ICD
Key exclusion criteria (6 listed)
- Documented valvular heart disease
- Acute myocardial infarction within the preceding 1 month
- Unstable angina
- Prolonged QT interval
- Patients with hemorrhagic or thrombophilic disorders
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 |
|---|---|---|
| Radiofrequency Catheter Ablation (RFCA)RFCA of clinical VT | Procedure or surgery | Clinical VT ablation |
| Radiofrequency Catheter Ablation (RFCA)RFCA of clinical VT as well as VT substrates | Procedure or surgery | clinical VT and substrate ablation |
Primary outcome
Recurrence of any sustained VT in the post-ablation period as demonstrated by electronic documentation Procedural complications associated with prolonged use of radiofrequency (RF) energy such as perforation, cardiac tamponade
Time frame: 48 hours
1 secondary outcome
Severe clinical events (hospital admissions for a cardiac cause, syncopal attacks, number of episodes of VT storms, death) Number of ICD interventions
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
- Derived from this study: PubMed 26718674Di Biase L, Burkhardt JD, Lakkireddy D, Carbucicchio C, Mohanty S, Mohanty P, Trivedi C, Santangeli P, Bai R, Forleo G, Horton R, Bailey S, Sanchez J, Al-Ahmad A, Hranitzky P, Gallinghouse GJ, Pelargonio G, Hongo RH, Beheiry S, Hao SC, Reddy M, Rossillo A, Themistoclakis S, Dello Russo A, Casella M, Tondo C, Natale A. Ablation of Stable VTs Versus Substrate Ablation in Ischemic Cardiomyopathy: The VISTA Randomized Multicenter Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2872-2882. doi: 10.1016/j.jacc.2015.10.026.
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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. This study is not recruiting at the moment.
Andrea Natale, MD FACC FHRS principal investigator
TCAI, St.David's Medical Center, Austin, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiofrequency Catheter Ablation (RFCA) in people with Ventricular Tachycardia, run by Texas Cardiac Arrhythmia Research Foundation at 1 site 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 6 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: finished, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence of any sustained VT in the post-ablation period as demonstrated by electronic documentation Procedural complications associated with prolonged use of radiofrequency (RF) energy such as perforation, cardiac tamponade (time frame: 48 hours). 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 NCT01045668, 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 25 Aug 2014.