Recurrent Ventricular TachycardiaPhase 4VANISHNCT00905853
Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy
A Phase 4 study testing Catheter Ablation and Escalated Antiarrhythmic Therapy in people with Recurrent Ventricular Tachycardia, run by John Sapp at 1 site in Canada.
Trial summary
This study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Ventricular Tachycardia
- What is being tested?
- Catheter Ablation and Escalated Antiarrhythmic Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Dec 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior Myocardial Infarction
- An implantable defibrillator
- One of the following VT events (within the past 3 months):
- greater than or equal to 3 episodes of symptomatic VT treated with ATP
- greater than or equal to 1 appropriate ICD shock
- greater than or equal to 3 VT episodes within 24 hours
Show all 10Show fewer
- sustained VT below detection rate of the ICD documented by ECG
- "Failed" first-line antiarrhythmic drug therapy as defined by one of:
- Appropriate ICD therapy or sustained VT occurred while patient was taking amiodarone (stable dose >/= 2 weeks)
- Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (stable dose >/= 2 weeks)
Who cannot join
- Active ischemia (acute thrombus, dynamic ST elevation on ECG) or another reversible cause of VT (eg. electrolyte abnormalities, drug induced arrhythmia)
- Are known to be ineligible to take amiodarone (eg. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy)
- Are ineligible for ablation (left ventricular thrombus, implanted mechanical aortic and mitral valves)
- Renal Failure (creatinine clearance < 15 ml/min)
- Current NYHA functional class IV heart failure or CCS Functional Class IV angina
- Recent ST elevation myocardial infarction (< 1 month)
Show all 11Show fewer
- Recent coronary bypass surgery (< 3 mon) or recent PCI (< 1 mon)
- Pregnant
- prior ablation for ventricular tachycardia
- A systemic illness likely to limit survival to < 1 year
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease
This study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy. The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent VT.
Read the detailed description
This is a multicentre, parallel group, two arm, unblinded, randomized clinical trial to compare two management strategies for patients with ischemic heart disease and recurrent ICD therapy despite at least one antiarrhythmic drug. The primary endpoint will be a composite of appropriate ICD shocks or death.
- Conditions
- Recurrent Ventricular Tachycardia
- Being tested
- Catheter Ablation, Escalated Antiarrhythmic Therapy
- Keywords
- Ventricular Tachycardia, Catheter Ablation, ICD therapy, Antiarrhythmic Drug Therapy, Ischemic Heart Disease
- Medical subject headings
- Tachycardia, Ventricular, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
Also called VT Ablation
Intracardiac electrode catheters are placed via central vasculature to identify myocardial scar, and surviving conduction channels within the scar which form the substrate for ventricular tachycardia. Radiofrequency energy is applied to these sites, interrupting the VT circuits.
Escalated Antiarrhythmic TherapyDrug
Also called Cordarone, Mexetil
Patients who have 'failed' antiarrhythmic therapy (except amiodarone) will be prescribed: Amiodarone 400 mg twice daily for 2 weeks, followed by 400 mg/day for 4 weeks, followed by 200 mg/day thereafter.
Patients who 'failed' amiodarone (less than 300mg/day) will be prescribed: Amiodarone 400 mg three times a day for 2 weeks, followed by 400 mg/day for 1 week and 300 mg/day thereafter.
Patients who 'failed' amiodarone (greater or equal to 300mg/day) will be prescribed: Amiodarone at the current dose with the addition of mexiletine 400 to 800 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Ventricular Tachycardia Ablation | Active comparator | Catheter ablation for Ventricular tachycardia will be performed within 14 days of randomization. Receives: Procedure: Catheter Ablation |
| Escalated Antiarrhythmic Drug Therapy | Active comparator | Patients are prescribed a loading dose of amiodarone or the addition of mexiletine to their current anti-arrhythmic medication which is stratified by the dose and type of antiarrhymic medication at the time of the index arrhythmic event. Receives: Drug: Escalated Antiarrhythmic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate ICD shocks,VT storm and death
Measured: 3 years
Secondary outcomes (9)
All cause mortality
Measured: 3 years
Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period
Measured: 3 years
appropriate ICD shocks anytime and after 1 month treatment period
Measured: 3 years
Inappropriate shocks anytime and after 1 month treatment period
Measured: 3 years
VT storm anytime and after 1 month treatment period
Measured: 3 years
Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period
Measured: 3 years
Number of ICD shocks
Measured: 3 years
Hospital admission for cardiac causes
Measured: 3 years
Procedural complications, amiodarone toxicity or adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Sapp
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Biosense Webster, Inc., Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, John Sapp, Nova Scotia Health Authority
- Investigators
- John L Sapp, BSc, MD, FRCPC, Principal investigator, Nova Scotia Health AuthorityRatika Parkash, MD, MSc, FRCPC, Study director, Nova Scotia Health AuthorityAnthony S Tang, MSc, MD, FRCPC, Study director, Royal Jubilee HospitalGeorge A Wells, BSc,MSc,PhD, Study director, Univeristy of Ottawa Heart InstituteWilliam G Stevenson, MD, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905853
- Sponsor's protocol ID
- Sapp001
- Acronym
- VANISH
- Status last verified
- Jul 2016
- First submitted
- 20 May 2009
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Parkash R, Nault I, Rivard L, Gula L, Essebag V, Nery P, Tung S, Raymond JM, Sterns L, Doucette S, Wells G, Tang ASL, Stevenson WG, Sapp JL. Effect of Baseline Antiarrhythmic Drug on Outcomes With Ablation in Ischemic Ventricular Tachycardia: A VANISH Substudy (Ventricular Tachycardia Ablation Versus Escalated Antiarrhythmic Drug Therapy in Ischemic Heart Disease). Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005663. doi: 10.1161/CIRCEP.117.005663.
PubMed 29305400Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.
PubMed 27149033
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease
- ClinicalTrials.gov ID
- NCT00905853
- Acronym / sponsor ID
- VANISH / Sapp001
- Conditions
- Recurrent Ventricular Tachycardia
- Keywords
- Ventricular Tachycardia, Catheter Ablation, ICD therapy, Antiarrhythmic Drug Therapy, Ischemic Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- John SappUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, Biosense Webster, Inc., Canadian Institutes of Health Research (CIHR)
- Study start
- May 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 May 2009 (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 will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy. The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent VT.
Detailed description
This is a multicentre, parallel group, two arm, unblinded, randomized clinical trial to compare two management strategies for patients with ischemic heart disease and recurrent ICD therapy despite at least one antiarrhythmic drug. The primary endpoint will be a composite of appropriate ICD shocks or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventricular Tachycardia Ablation | Active comparator | Procedure: Catheter AblationCatheter ablation for Ventricular tachycardia will be performed within 14 days of randomization. |
| Escalated Antiarrhythmic Drug Therapy | Active comparator | Drug: Escalated Antiarrhythmic TherapyPatients are prescribed a loading dose of amiodarone or the addition of mexiletine to their current anti-arrhythmic medication which is stratified by the dose and type of antiarrhymic medication at the time of the index arrhythmic event. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Prior Myocardial Infarction
- An implantable defibrillator
- One of the following VT events (within the past 3 months):
- "Failed" first-line antiarrhythmic drug therapy as defined by one of:
Key exclusion criteria (11 listed)
- Active ischemia (acute thrombus, dynamic ST elevation on ECG) or another reversible cause of VT (eg. electrolyte abnormalities, drug induced arrhythmia)
- Are known to be ineligible to take amiodarone (eg. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy)
- Are ineligible for ablation (left ventricular thrombus, implanted mechanical aortic and mitral valves)
- Renal Failure (creatinine clearance < 15 ml/min)
- Current NYHA functional class IV heart failure or CCS Functional Class IV angina
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 |
|---|---|---|
| Catheter AblationAlso: VT AblationIntracardiac electrode catheters are placed via central vasculature to identify myocardial scar, and surviving conduction channels within the scar which form the substrate for ventricular tachycardia. Radiofrequency energy is applied to these sites, interrupting the VT circuits. | Procedure or surgery | Ventricular Tachycardia Ablation |
| Escalated Antiarrhythmic TherapyAlso: Cordarone, MexetilPatients who have 'failed' antiarrhythmic therapy (except amiodarone) will be prescribed: Amiodarone 400 mg twice daily for 2 weeks, followed by 400 mg/day for 4 weeks, followed by 200 mg/day thereafter. Patients who 'failed' amiodarone (less than 300mg/day) will be prescribed: Amiodarone 400 mg three times a day for 2 weeks, followed by 400 mg/day for 1 week and 300 mg/day thereafter. Patients who 'failed' amiodarone (greater or equal to 300mg/day) will be prescribed: Amiodarone at the current dose with the addition of mexiletine 400 to 800 mg/day | Drug | Escalated Antiarrhythmic Drug Therapy |
Primary outcome
Appropriate ICD shocks,VT storm and death
Time frame: 3 years
9 secondary outcomes
All cause mortality
Time frame: 3 years
Appropriate ICD antitachycardia pacing anytime and after 1 month treatment period
Time frame: 3 years
appropriate ICD shocks anytime and after 1 month treatment period
Time frame: 3 years
Inappropriate shocks anytime and after 1 month treatment period
Time frame: 3 years
VT storm anytime and after 1 month treatment period
Time frame: 3 years
Documented sustained VT below detection rate of the ICD any time and after 1 month treatment period
Time frame: 3 years
Number of ICD shocks
Time frame: 3 years
Hospital admission for cardiac causes
Time frame: 3 years
Procedural complications, amiodarone toxicity or adverse events
Time frame: 3 years
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 11 Jul 2016.
- Derived from this study: PubMed 29305400Parkash R, Nault I, Rivard L, Gula L, Essebag V, Nery P, Tung S, Raymond JM, Sterns L, Doucette S, Wells G, Tang ASL, Stevenson WG, Sapp JL. Effect of Baseline Antiarrhythmic Drug on Outcomes With Ablation in Ischemic Ventricular Tachycardia: A VANISH Substudy (Ventricular Tachycardia Ablation Versus Escalated Antiarrhythmic Drug Therapy in Ischemic Heart Disease). Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005663. doi: 10.1161/CIRCEP.117.005663.
- Derived from this study: PubMed 27149033Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.
- PublicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Recurrent Ventricular Tachycardia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Recruiting
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Ventricular Tachycardia (VT)
RecruitingPhase 1
Dose Escalation for SBRT of Recurrent VT Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial
Ventricular Tachycardia
Recruiting
Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial
Sustained Monomorphic VT (MMVT), Recurrent Ventricular Tachycardia
RecruitingPhase 3
Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm
Ventricular Tachycardia, Ventricular Arrhythmias
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.
John L Sapp, BSc, MD, FRCPC principal investigator
Nova Scotia Health Authority
Ratika Parkash, MD, MSc, FRCPC study director
Nova Scotia Health Authority
Anthony S Tang, MSc, MD, FRCPC study director
Royal Jubilee Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Catheter Ablation and Escalated Antiarrhythmic Therapy in people with Recurrent Ventricular Tachycardia, run by John Sapp at 1 site in Canada.
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 10 inclusion and 11 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 11 Jul 2016. 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 Canada. 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?
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?
Appropriate ICD shocks,VT storm and death (time frame: 3 years). 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 NCT00905853, which also lists 2 linked publications.
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 11 Jul 2016.