Ventricular TachycardiaCALYPSONCT01576042
Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator
A study testing amiodarone, sotalol and Biosense Webster's NAVI-STAR Thermo-Cool in people with Ventricular Tachycardia, run by Duke University at 5 sites in United States.
Trial summary
The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is superior to state-of-the-art pharmacologic therapy at reducing all-cause mortality in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- amiodarone, sotalol and Biosense Webster's NAVI-STAR Thermo-Cool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2012to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have an ICD with or without cardiac resynchronization therapy (i.e. CRT-D) for a primary or secondary prevention indication
- Have ischemic heart disease defined as the presence of wall motion abnormalities and documented coronary artery disease (one ≥ 70% stenosis in ≥ 1 major coronary artery)
- Have ≥ 1 documented ICD shock or ≥ 3 ATP therapies within 6 months before randomization for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy. The VT has to be monomorphic and at a rate of ≤ 260 bpm.
- Be at least 18 years of age
- Be eligible for catheter ablation
- Have no history of intolerance or contraindication to at least 1 of the following antiarrhythmic medications: amiodarone, sotalol, and mexiletine.
Who cannot join
- Patients who in the opinion of the treating physician should not receive additional therapy
- More than 30 days of amiodarone treatment in the past 3 months unless the patient has been on ≤ 200 mgs of amiodarone daily for atrial arrhythmias or premature ventricular contractions (PVCs) and the patient is eligible for a higher dose of amiodarone
- Incessant VT that necessitates immediate treatment
- Reversible causes of VT including but not limited to ischemia, decompensated HF, and electrolyte disturbances
- The presence of a contraindication to catheter ablation of VT (including the presence of a mobile ventricular thrombus; an acute MI, coronary revascularization, or a stroke in the preceding 30 days; unstable angina or NYHA class IV HF; a mechanical valve; or inability to receive anticoagulation or antithrombotic therapy)
- Patients with non-ischemic cardiomyopathy
Show all 16Show fewer
- Patients with hypertrophic obstructive, restrictive, or infiltrative cardiomyopathy
- Patients with acute myocarditis, congenital heart disease, valvular disease likely to require surgery in the next 1 year, and/or inoperable obstructive valvular disease
- Patients with a heart transplant or who are expected to undergo cardiac transplantation within 12 months
- Patients with a left ventricular assist device
- Patients who are already on antiarrhythmic drug therapy (other than beta-blockers) for VT (patients will not be excluded if they are receiving antiarrhythmic drug therapy for atrial arrhythmias or PVCs if they are eligible for additional drug therapy for VT).
- Heritable arrhythmias or increased risk for torsade de pointes with class III drugs
- End stage renal disease requiring dialysis
- Estimated life expectancy of <1 year from a non-cardiac cause
- Women who are pregnant or who have childbearing potential and are not using a reliable method of contraception
- Inability to give informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Ohio State University Medical Center
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15237
About this study
Official title: Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator (CALYPSO) PILOT TRIAL
The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is superior to state-of-the-art pharmacologic therapy at reducing all-cause mortality in patients with an implantable cardioverter defibrillator (ICD) who receive therapy for VT in the absence of any reversible cause.
Read the detailed description
This study will be conducted at up to 8 sites and will randomize 50 patients over 1 year to a strategy of catheter ablation (n=25) vs. state-of-the-art pharmacologic therapy (n=25). To be considered for enrollment in this pilot trial, patients must be at least 18 years of age and must have an ICD for a primary or secondary prevention indication, have ≥ 1 documented ICD shock or ≥ 3 ATP therapies for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy and be eligible for both catheter ablation and at least 1 antiarrhythmic medication. Patients will be followed at 3 and 6 months and their vital status will be determined via a phone call at 12 months. Data on the safety and efficacy of therapies used in the pilot study will be collected. Of particular interest are adverse events resulting from the catheter ablation procedure and major side effects from antiarrhythmic medications.
- Conditions
- Ventricular Tachycardia
- Being tested
- amiodarone, sotalol, Biosense Webster's NAVI-STAR Thermo-Cool
- Keywords
- Ischemic heart disease, Implantable Cardioverter Defibrillator, Ventricular Tachycardia, Patient with Implantable Cardioverter Defibrillator (ICD)
- 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.
amiodaroneDrug
Also called Cordarone
The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
sotalolDrug
Also called Betapace, Betapace AF, Sotalex, Sotacor
The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
Biosense Webster's NAVI-STAR Thermo-CoolDevice
The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults.
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation | Other | The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults Receives: Device: Biosense Webster's NAVI-STAR Thermo-Cool |
| Antiarrhythmic medication | Other | The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death Receives: Drug: amiodarone; Drug: sotalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completed Month 3 Follow-Up
Records participants who completed Month 3 Follow-Up Visit
Measured: 3 months
Secondary outcomes (7)
Number of Participants Completed Month 6 Follow-Up
Records participants who completed Month 6 Follow-Up Visit
Measured: 6 Months
Number of Participants Had at Least One of the Efficacy Outcome Measurement
Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)
Measured: 6 Months
Cardiovascular Hospitalizations
Records participants hospitalized for VT during the study
Measured: Baseline, 6 months
Number of Participants Remained on Randomized Treatment Assignment
Records participants who only received study treatment as randomized during the entire study
Measured: 6 month
Number of Participants Switched to Other Arm
Records participants who received study treatment as randomized and later switched to other treatment arm during the study
Measured: 6 months
Time to First Recurrent ICD Therapy for VT
Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT.
Measured: Baseline, 6 months
Number of Participants Received Treatment Assigned
Records participants who received study randomized treatment during the study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Main objectives of the study were met; consensus among investigators that continuing the study would not add new information beyond that already learned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Sana M Al-Khatib, MD, MHS, Principal investigator, Duke UniversityWilliam Stevenson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576042
- Sponsor's protocol ID
- Pro00033180
- Other IDs
- Pro00036518
- Acronym
- CALYPSO
- Status last verified
- Sep 2014
- First submitted
- 3 Apr 2012
- Last updated
- 16 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Myerburg RJ, Kessler KM, Castellanos A. Sudden cardiac death: epidemiology, transient risk, and intervention assessment. Ann Intern Med. 1993 Dec 15;119(12):1187-97. doi: 10.7326/0003-4819-119-12-199312150-00006.
PubMed 8239250Gilman JK, Jalal S, Naccarelli GV. Predicting and preventing sudden death from cardiac causes. Circulation. 1994 Aug;90(2):1083-92. doi: 10.1161/01.cir.90.2.1083.
PubMed 7913885Zipes DP, Wellens HJ. Sudden cardiac death. Circulation. 1998 Nov 24;98(21):2334-51. doi: 10.1161/01.cir.98.21.2334. No abstract available.
PubMed 9826323Zheng ZJ, Croft JB, Giles WH, Mensah GA. Sudden cardiac death in the United States, 1989 to 1998. Circulation. 2001 Oct 30;104(18):2158-63. doi: 10.1161/hc4301.098254.
PubMed 11684624Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997 Nov 27;337(22):1576-83. doi: 10.1056/NEJM199711273372202.
PubMed 9411221Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
PubMed 11907286Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, Anderson KP, Calkins H, Hoch D, Goldberger J, Shalaby A, Sanders WE, Schaechter A, Levine JH; Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004 May 20;350(21):2151-8. doi: 10.1056/NEJMoa033088.
PubMed 15152060Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.
PubMed 15659722Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices); American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation. 2008 May 27;117(21):e350-408. doi: 10.1161/CIRCUALTIONAHA.108.189742. Epub 2008 May 15. No abstract available.
PubMed 18483207Hammill SC, Stevenson LW, Kadish AH, Kremers MS, Heidenreich P, Lindsay BD, Mirro MJ, Radford MJ, Wang Y, Lang CM, Harder JC, Brindis RG. Review of the registry's first year, data collected, and future plans. Heart Rhythm. 2007 Sep;4(9):1260-3. doi: 10.1016/j.hrthm.2007.07.021. Epub 2007 Jul 25. No abstract available.
PubMed 17765637Hammill SC, Kremers MS, Stevenson LW, Kadish AH, Heidenreich PA, Lindsay BD, Mirro MJ, Radford MJ, Wang Y, Curtis JP, Lang CM, Harder JC, Brindis RG. Review of the Registry's second year, data collected, and plans to add lead and pediatric ICD procedures. Heart Rhythm. 2008 Sep;5(9):1359-63. doi: 10.1016/j.hrthm.2008.07.015. Epub 2008 Jul 22. No abstract available.
PubMed 18774117Hammill SC, Kremers MS, Kadish AH, Stevenson LW, Heidenreich PA, Lindsay BD, Mirro MJ, Radford MJ, McKay C, Wang Y, Lang CM, Pontzer K, Rumsfeld J, Phurrough SE, Curtis JP, Brindis RG. Review of the ICD Registry's third year, expansion to include lead data and pediatric ICD procedures, and role for measuring performance. Heart Rhythm. 2009 Sep;6(9):1397-401. doi: 10.1016/j.hrthm.2009.07.015. Epub 2009 Jul 16. No abstract available.
PubMed 19716099Hammill SC, Kremers MS, Stevenson LW, Heidenreich PA, Lang CM, Curtis JP, Wang Y, Berul CI, Kadish AH, Al-Khatib SM, Pina IL, Walsh MN, Mirro MJ, Lindsay BD, Reynolds MR, Pontzer K, Blum L, Masoudi F, Rumsfeld J, Brindis RG. Review of the registry's fourth year, incorporating lead data and pediatric ICD procedures, and use as a national performance measure. Heart Rhythm. 2010 Sep;7(9):1340-5. doi: 10.1016/j.hrthm.2010.07.015. Epub 2010 Jul 18. No abstract available.
PubMed 20647056Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. doi: 10.1056/NEJMoa071098.
PubMed 18768944Sweeney MO, Sherfesee L, DeGroot PJ, Wathen MS, Wilkoff BL. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Mar;7(3):353-60. doi: 10.1016/j.hrthm.2009.11.027. Epub 2009 Dec 2.
PubMed 20185109
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator (CALYPSO) PILOT TRIAL
- ClinicalTrials.gov ID
- NCT01576042
- Acronym / sponsor ID
- CALYPSO / Pro00033180
- Conditions
- Ventricular Tachycardia
- Keywords
- Ischemic heart disease, Implantable Cardioverter Defibrillator, Ventricular Tachycardia, Patient with Implantable Cardioverter Defibrillator (ICD)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Main objectives of the study were met; consensus among investigators that continuing the study would not add new information beyond that already learned.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is superior to state-of-the-art pharmacologic therapy at reducing all-cause mortality in patients with an implantable cardioverter defibrillator (ICD) who receive therapy for VT in the absence of any reversible cause.
Detailed description
This study will be conducted at up to 8 sites and will randomize 50 patients over 1 year to a strategy of catheter ablation (n=25) vs. state-of-the-art pharmacologic therapy (n=25). To be considered for enrollment in this pilot trial, patients must be at least 18 years of age and must have an ICD for a primary or secondary prevention indication, have ≥ 1 documented ICD shock or ≥ 3 ATP therapies for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy and be eligible for both catheter ablation and at least 1 antiarrhythmic medication. Patients will be followed at 3 and 6 months and their vital status will be determined via a phone call at 12 months. Data on the safety and efficacy of therapies used in the pilot study will be collected. Of particular interest are adverse events resulting from the catheter ablation procedure and major side effects from antiarrhythmic medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation | Other | Device: Biosense Webster's NAVI-STAR Thermo-CoolThe only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults |
| Antiarrhythmic medication | Other | Drug: amiodarone, Drug: sotalolThe choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have an ICD with or without cardiac resynchronization therapy (i.e. CRT-D) for a primary or secondary prevention indication
- Have ischemic heart disease defined as the presence of wall motion abnormalities and documented coronary artery disease (one ≥ 70% stenosis in ≥ 1 major coronary artery)
- Have ≥ 1 documented ICD shock or ≥ 3 ATP therapies within 6 months before randomization for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy. The VT has to be monomorphic and at a rate of ≤ 260 bpm.
- Be at least 18 years of age
- Be eligible for catheter ablation
Key exclusion criteria (16 listed)
- Patients who in the opinion of the treating physician should not receive additional therapy
- More than 30 days of amiodarone treatment in the past 3 months unless the patient has been on ≤ 200 mgs of amiodarone daily for atrial arrhythmias or premature ventricular contractions (PVCs) and the patient is eligible for a higher dose of amiodarone
- Incessant VT that necessitates immediate treatment
- Reversible causes of VT including but not limited to ischemia, decompensated HF, and electrolyte disturbances
- The presence of a contraindication to catheter ablation of VT (including the presence of a mobile ventricular thrombus; an acute MI, coronary revascularization, or a stroke in the preceding 30 days; unstable angina or NYHA class IV HF; a mechanical valve; or inability to receive anticoagulation or antithrombotic therapy)
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 |
|---|---|---|
| amiodaroneAlso: CordaroneThe dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. | Drug | Antiarrhythmic medication |
| sotalolAlso: Betapace, Betapace AF, Sotalex, SotacorThe choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. | Drug | Antiarrhythmic medication |
| Biosense Webster's NAVI-STAR Thermo-CoolThe only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults. | Device | Catheter ablation |
Primary outcome
Number of Participants Completed Month 3 Follow-Up
Time frame: 3 months
Records participants who completed Month 3 Follow-Up Visit
7 secondary outcomes
Number of Participants Completed Month 6 Follow-Up
Time frame: 6 Months
Number of Participants Had at Least One of the Efficacy Outcome Measurement
Time frame: 6 Months
Cardiovascular Hospitalizations
Time frame: Baseline, 6 months
Number of Participants Remained on Randomized Treatment Assignment
Time frame: 6 month
Number of Participants Switched to Other Arm
Time frame: 6 months
Time to First Recurrent ICD Therapy for VT
Time frame: Baseline, 6 months
Number of Participants Received Treatment Assigned
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8239250Myerburg RJ, Kessler KM, Castellanos A. Sudden cardiac death: epidemiology, transient risk, and intervention assessment. Ann Intern Med. 1993 Dec 15;119(12):1187-97. doi: 10.7326/0003-4819-119-12-199312150-00006.
- Background: PubMed 7913885Gilman JK, Jalal S, Naccarelli GV. Predicting and preventing sudden death from cardiac causes. Circulation. 1994 Aug;90(2):1083-92. doi: 10.1161/01.cir.90.2.1083.
- Background: PubMed 9826323Zipes DP, Wellens HJ. Sudden cardiac death. Circulation. 1998 Nov 24;98(21):2334-51. doi: 10.1161/01.cir.98.21.2334. No abstract available.
- Background: PubMed 11684624Zheng ZJ, Croft JB, Giles WH, Mensah GA. Sudden cardiac death in the United States, 1989 to 1998. Circulation. 2001 Oct 30;104(18):2158-63. doi: 10.1161/hc4301.098254.
- Background: PubMed 9411221Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997 Nov 27;337(22):1576-83. doi: 10.1056/NEJM199711273372202.
- Background: PubMed 11907286Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
- Background: PubMed 15152060Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, Anderson KP, Calkins H, Hoch D, Goldberger J, Shalaby A, Sanders WE, Schaechter A, Levine JH; Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004 May 20;350(21):2151-8. doi: 10.1056/NEJMoa033088.
- Background: PubMed 15659722Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.
- Background: PubMed 18483207Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices); American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation. 2008 May 27;117(21):e350-408. doi: 10.1161/CIRCUALTIONAHA.108.189742. Epub 2008 May 15. No abstract available.
- Background: PubMed 17765637Hammill SC, Stevenson LW, Kadish AH, Kremers MS, Heidenreich P, Lindsay BD, Mirro MJ, Radford MJ, Wang Y, Lang CM, Harder JC, Brindis RG. Review of the registry's first year, data collected, and future plans. Heart Rhythm. 2007 Sep;4(9):1260-3. doi: 10.1016/j.hrthm.2007.07.021. Epub 2007 Jul 25. No abstract available.
- Background: PubMed 18774117Hammill SC, Kremers MS, Stevenson LW, Kadish AH, Heidenreich PA, Lindsay BD, Mirro MJ, Radford MJ, Wang Y, Curtis JP, Lang CM, Harder JC, Brindis RG. Review of the Registry's second year, data collected, and plans to add lead and pediatric ICD procedures. Heart Rhythm. 2008 Sep;5(9):1359-63. doi: 10.1016/j.hrthm.2008.07.015. Epub 2008 Jul 22. No abstract available.
- Background: PubMed 19716099Hammill SC, Kremers MS, Kadish AH, Stevenson LW, Heidenreich PA, Lindsay BD, Mirro MJ, Radford MJ, McKay C, Wang Y, Lang CM, Pontzer K, Rumsfeld J, Phurrough SE, Curtis JP, Brindis RG. Review of the ICD Registry's third year, expansion to include lead data and pediatric ICD procedures, and role for measuring performance. Heart Rhythm. 2009 Sep;6(9):1397-401. doi: 10.1016/j.hrthm.2009.07.015. Epub 2009 Jul 16. No abstract available.
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Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
Sana M Al-Khatib, MD, MHS principal investigator
Duke University
William Stevenson, MD principal investigator
Brigham and Women's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amiodarone, sotalol and Biosense Webster's NAVI-STAR Thermo-Cool in people with Ventricular Tachycardia, run by Duke University at 5 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Completed Month 3 Follow-Up (time frame: 3 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 NCT01576042, which also lists 36 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 16 Oct 2014.