Ventricular TachycardiaIMPRESSNCT03531502
Initial Management of Patients Receiving a Single Shock (IMPRESS)
A study testing Ventricular Tachycardia Ablation, Standard Medical Therapy and Non-Invasive Programmed Stimulation (NIPS) in people with Ventricular Tachycardia, run by Saint Luke's Health System at 1 site in United States.
Trial summary
The goal of this study is to determine the optimal treatment for patients who receive a single shock from their implantable cardioverter defibrillator (ICD). All participants in this study will be fitted with a special electrode vest to detect the origin of heart rhythm abnormalities and then they will undergo a… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Ventricular Tachycardia Ablation, Standard Medical Therapy and Non-Invasive Programmed Stimulation (NIPS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 4 Apr 2023
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old, both males and females
- Single or dual chamber ICD or BiVentricular ICD in situ
- Ischemic or non-ischemic cardiomyopathy
- Receive a single shock from their ICD for monomorphic ventricular tachycardia
Who cannot join
- ICD shock for polymorphic VT/VF or inappropriate shock
- Previous ventricular tachycardia ablation within 1 year
- NYHA Class IV heart failure or current inotrope therapy
- Ventricular tachycardia storm
- Listed for heart transplant or LVAD
- Pregnant as determined by urine pregnancy test prior to NIPS
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
About this study
The goal of this study is to determine the optimal treatment for patients who receive a single shock from their implantable cardioverter defibrillator (ICD). All participants in this study will be fitted with a special electrode vest to detect the origin of heart rhythm abnormalities and then they will undergo a procedure called Non-Invasive Programmed Stimulation (NIPS). This procedure involves sedating a participants with anesthesia and then using the participant's own ICD to try to stimulate the heart to go into ventricular tachycardia. If this procedure is unable to induce the participant into ventricular tachycardia, then the participant will just be managed with usual care and will not be placed on any additional medications and will not undergo an ablation. However, if the NIPS induces the ventricular tachycardia, the electrode vest will be used to determine the origin of the abnormal heart rhythm inside the heart. After a successful NIPS procedure, the participants will be randomly assigned to either be placed on medication therapy or undergo catheter ablation. The outcomes from all three groups will be compared and the researchers hope to better understand which participants are most likely to benefit from watchful waiting versus medication versus catheter ablation.
Read the detailed description
Patients with a history of ventricular tachycardia requiring defibrillation or who are at risk for developing ventricular tachycardia will undergo placement of an implantable cardioverter defibrillator (ICD) for purposes of prevention of sudden cardiac arrest. While the ICD is lifesaving, if a patient receives a shock from their ICD it is painful and the entire experience is very traumatic. Traditionally, the management of these patients who receive a single shock from their ICD is variable because it is not known if the patient will continue to experience further shocks or not. Some physicians will initiate antiarrhythmic medical therapy after only a single shock, whereas others will wait until the patient has recurrent ICD shocks before initiating therapy. All patients should be counseled to not drive for 6 months following a shock. Ventricular tachycardia ablation, a procedure involving placing catheters from the groin into the chambers of the heart to isolate the source of ventricular tachycardia and eliminate these foci through delivery of radiofrequency energy, is typically reserved for patients with multiple recurrent cases of ventricular tachycardia. While some studies have shown that ventricular tachycardia ablations can be done safely at an earlier course of the disease and this procedure has been demonstrated to reduce further ICD shocks, this practice is not commonplace.
Patients who undergo a ventricular tachycardia ablation procedure, will initially have catheters placed into the ventricular chambers of the heart and these catheters will be used to stimulate the heart in an attempt to induce the ventricular tachycardia, a process known as programmed stimulation. One major limitation of a ventricular tachycardia ablation procedure is the need to be able to induce the ventricular tachycardia rhythm via programmed stimulation. If this rhythm cannot be induced then it is very difficult to perform the ventricular tachycardia ablation procedure. Non-invasive programmed stimulation (NIPS) is a means of performing programmed stimulation using the patient's own ICD and does not involve placing catheters into the heart.
Aim: The aim of this study is to investigate if non-invasive programmed stimulation (NIPS) can be used to risk stratify patients determine if earlier intervention with either antiarrhythmic medications or ablation in patients with recurrent ventricular tachycardia that received ICD shocks would help decrease further ICD shocks and hospitalizations for ventricular arrhythmias.
Primary hypothesis: Patients receiving a single ICD shock for ventricular tachycardia who undergo a non-invasive programmed stimulation (NIPS) that fails to induce any sustained ventricular tachycardia, are at low likelihood of experiencing recurrent ICD shocks within the next year.
Secondary hypothesis: For patients receiving a single ICD shock for ventricular tachycardia who undergo non-invasive programmed stimulation (NIPS) that induces a sustained, monomorphic ventricular tachycardia rhythm, the performance of ventricular tachycardia ablation will reduce the incidence of recurrent ICD shocks within the next year, as compared to antiarrhythmic therapy alone.
- Conditions
- Ventricular Tachycardia
- Being tested
- Ventricular Tachycardia Ablation, Standard Medical Therapy, Non-Invasive Programmed Stimulation (NIPS)
- Keywords
- tachycardia, defibrillator, arrythmia
- Medical subject headings
- Tachycardia, Ventricular, Tachycardia, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventricular Tachycardia AblationProcedure or surgery
Ventricular Tachycardia Ablation
Standard Medical TherapyOther
For the antiarrhythmic naïve patients, the attending physician may initiate therapy with sotalol or amiodarone. For patients already on therapy with sotalol or amiodarone, the attending physician may choose to either increase the dosage/ frequency of these medications and/or add mexiletine to the regimen. Other alterations to medical therapy, such as adjusting the dose of beta-blockers, calcium-channel blockers, anti-hypertensive, diuretic or anti-anginal medications may be performed at the discretion of the attending physician.
Non-Invasive Programmed Stimulation (NIPS)Procedure or surgery
All patients will receive this procedure in attempt to induce ventricular tachycardia. The outcome of this procedure determines if a patient will be randomized.
| Study group | Role | What they receive |
|---|---|---|
| Standard medical therapy | Active comparator | Patients who have a positive NIPS study and are randomized to the medical therapy arm will either be initiated on antiarrhythmic therapy or will have their antiarrhythmic therapy intensified. All medication therapy is considered usual standard therapy. Receives: Other: Standard Medical Therapy; Procedure: Non-Invasive Programmed Stimulation (NIPS) |
| Ventricular Tachycardia Ablation | Experimental | Patients who have a positive NIPS study and are randomized to the ablation arm will undergo ventricular tachycardia ablation procedure guided by CardioInsight. Receives: Procedure: Ventricular Tachycardia Ablation; Procedure: Non-Invasive Programmed Stimulation (NIPS) |
| Negative NIPS/Non-intervention | Other | Patients who had a negative NIPS study will not be assigned to a treatment group and will be followed according to standard of care. Receives: Procedure: Non-Invasive Programmed Stimulation (NIPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICD Shocks
Number of recurrent ICD shocks
Measured: 12 months
Secondary outcomes (7)
Total Mortality
Number of related deaths
Measured: 12 months
Hospitalizations
Number of related hospitalizations
Measured: 12 months
ATP Therapy as recorded by ICD
Number of ATP therapies administered by ICD
Measured: 12 months
Non-sustained VT
Measured: 12 months
Initiation of antiarrythmic medication
Number of times new medical therapy was started as documented in the medical record
Measured: 12 months
Modification of antiarrythmic medication
Number of times medical therapy was changed
Measured: 12 months
Repeat ablation
Number of repeat ablation procedures
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 posted21 May 2018
- Study start9 Apr 2018
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, controlled
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Sanjaya Gupta, MD, Principal investigator, Saint Luke's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531502
- Sponsor's protocol ID
- IMPRESS
- Acronym
- IMPRESS
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2018
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65. doi: 10.1056/NEJMoa065457.
PubMed 18160685Sapp 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 27149033Frankel DS, Mountantonakis SE, Zado ES, Anter E, Bala R, Cooper JM, Deo R, Dixit S, Epstein AE, Garcia FC, Gerstenfeld EP, Hutchinson MD, Lin D, Patel VV, Riley MP, Robinson MR, Tzou WS, Verdino RJ, Callans DJ, Marchlinski FE. Noninvasive programmed ventricular stimulation early after ventricular tachycardia ablation to predict risk of late recurrence. J Am Coll Cardiol. 2012 Apr 24;59(17):1529-35. doi: 10.1016/j.jacc.2012.01.026.
PubMed 22516442Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.
PubMed 31698933
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Management of Patients Receiving a Single Shock (IMPRESS)
- ClinicalTrials.gov ID
- NCT03531502
- Acronym / sponsor ID
- IMPRESS / IMPRESS
- Conditions
- Ventricular Tachycardia
- Keywords
- tachycardia, defibrillator, arrythmia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 21 May 2018 (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.
The goal of this study is to determine the optimal treatment for patients who receive a single shock from their implantable cardioverter defibrillator (ICD). All participants in this study will be fitted with a special electrode vest to detect the origin of heart rhythm abnormalities and then they will undergo a procedure called Non-Invasive Programmed Stimulation (NIPS). This procedure involves sedating a participants with anesthesia and then using the participant's own ICD to try to stimulate the heart to go into ventricular tachycardia. If this procedure is unable to induce the participant into ventricular tachycardia, then the participant will just be managed with usual care and will not be placed on any additional medications and will not undergo an ablation. However, if the NIPS induces the ventricular tachycardia, the electrode vest will be used to determine the origin of the abnormal heart rhythm inside the heart. After a successful NIPS procedure, the participants will be randomly assigned to either be placed on medication therapy or undergo catheter ablation. The outcomes from all three groups will be compared and the researchers hope to better understand which participants are most likely to benefit from watchful waiting versus medication versus catheter ablation.
Detailed description
Patients with a history of ventricular tachycardia requiring defibrillation or who are at risk for developing ventricular tachycardia will undergo placement of an implantable cardioverter defibrillator (ICD) for purposes of prevention of sudden cardiac arrest. While the ICD is lifesaving, if a patient receives a shock from their ICD it is painful and the entire experience is very traumatic. Traditionally, the management of these patients who receive a single shock from their ICD is variable because it is not known if the patient will continue to experience further shocks or not. Some physicians will initiate antiarrhythmic medical therapy after only a single shock, whereas others will wait until the patient has recurrent ICD shocks before initiating therapy. All patients should be counseled to not drive for 6 months following a shock. Ventricular tachycardia ablation, a procedure involving placing catheters from the groin into the chambers of the heart to isolate the source of ventricular tachycardia and eliminate these foci through delivery of radiofrequency energy, is typically reserved for patients with multiple recurrent cases of ventricular tachycardia. While some studies have shown that ventricular tachycardia ablations can be done safely at an earlier course of the disease and this procedure has been demonstrated to reduce further ICD shocks, this practice is not commonplace.
Patients who undergo a ventricular tachycardia ablation procedure, will initially have catheters placed into the ventricular chambers of the heart and these catheters will be used to stimulate the heart in an attempt to induce the ventricular tachycardia, a process known as programmed stimulation. One major limitation of a ventricular tachycardia ablation procedure is the need to be able to induce the ventricular tachycardia rhythm via programmed stimulation. If this rhythm cannot be induced then it is very difficult to perform the ventricular tachycardia ablation procedure. Non-invasive programmed stimulation (NIPS) is a means of performing programmed stimulation using the patient's own ICD and does not involve placing catheters into the heart.
Aim: The aim of this study is to investigate if non-invasive programmed stimulation (NIPS) can be used to risk stratify patients determine if earlier intervention with either antiarrhythmic medications or ablation in patients with recurrent ventricular tachycardia that received ICD shocks would help decrease further ICD shocks and hospitalizations for ventricular arrhythmias.
Primary hypothesis: Patients receiving a single ICD shock for ventricular tachycardia who undergo a non-invasive programmed stimulation (NIPS) that fails to induce any sustained ventricular tachycardia, are at low likelihood of experiencing recurrent ICD shocks within the next year.
Secondary hypothesis: For patients receiving a single ICD shock for ventricular tachycardia who undergo non-invasive programmed stimulation (NIPS) that induces a sustained, monomorphic ventricular tachycardia rhythm, the performance of ventricular tachycardia ablation will reduce the incidence of recurrent ICD shocks within the next year, as compared to antiarrhythmic therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective, randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| Standard medical therapy | Active comparator | Other: Standard Medical Therapy, Procedure: Non-Invasive Programmed Stimulation (NIPS)Patients who have a positive NIPS study and are randomized to the medical therapy arm will either be initiated on antiarrhythmic therapy or will have their antiarrhythmic therapy intensified. All medication therapy is considered usual standard therapy. |
| Ventricular Tachycardia Ablation | Experimental | Procedure: Ventricular Tachycardia Ablation, Procedure: Non-Invasive Programmed Stimulation (NIPS)Patients who have a positive NIPS study and are randomized to the ablation arm will undergo ventricular tachycardia ablation procedure guided by CardioInsight. |
| Negative NIPS/Non-intervention | Other | Procedure: Non-Invasive Programmed Stimulation (NIPS)Patients who had a negative NIPS study will not be assigned to a treatment group and will be followed according to standard of care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years old, both males and females
- Single or dual chamber ICD or BiVentricular ICD in situ
- Ischemic or non-ischemic cardiomyopathy
- Receive a single shock from their ICD for monomorphic ventricular tachycardia
Key exclusion criteria (6 listed)
- ICD shock for polymorphic VT/VF or inappropriate shock
- Previous ventricular tachycardia ablation within 1 year
- NYHA Class IV heart failure or current inotrope therapy
- Ventricular tachycardia storm
- Listed for heart transplant or LVAD
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 |
|---|---|---|
| Ventricular Tachycardia AblationVentricular Tachycardia Ablation | Procedure or surgery | Ventricular Tachycardia Ablation |
| Standard Medical TherapyFor the antiarrhythmic naïve patients, the attending physician may initiate therapy with sotalol or amiodarone. For patients already on therapy with sotalol or amiodarone, the attending physician may choose to either increase the dosage/ frequency of these medications and/or add mexiletine to the regimen. Other alterations to medical therapy, such as adjusting the dose of beta-blockers, calcium-channel blockers, anti-hypertensive, diuretic or anti-anginal medications may be performed at the discretion of the attending physician. | Other | Standard medical therapy |
| Non-Invasive Programmed Stimulation (NIPS)All patients will receive this procedure in attempt to induce ventricular tachycardia. The outcome of this procedure determines if a patient will be randomized. | Procedure or surgery | Negative NIPS/Non-intervention, Standard medical therapy, Ventricular Tachycardia Ablation |
Primary outcome
ICD Shocks
Time frame: 12 months
Number of recurrent ICD shocks
7 secondary outcomes
Total Mortality
Time frame: 12 months
Hospitalizations
Time frame: 12 months
ATP Therapy as recorded by ICD
Time frame: 12 months
Non-sustained VT
Time frame: 12 months
Initiation of antiarrythmic medication
Time frame: 12 months
Modification of antiarrythmic medication
Time frame: 12 months
Repeat ablation
Time frame: 12 months
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Results publication: PubMed 18160685Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65. doi: 10.1056/NEJMoa065457.
- Results publication: 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.
- Results publication: PubMed 22516442Frankel DS, Mountantonakis SE, Zado ES, Anter E, Bala R, Cooper JM, Deo R, Dixit S, Epstein AE, Garcia FC, Gerstenfeld EP, Hutchinson MD, Lin D, Patel VV, Riley MP, Robinson MR, Tzou WS, Verdino RJ, Callans DJ, Marchlinski FE. Noninvasive programmed ventricular stimulation early after ventricular tachycardia ablation to predict risk of late recurrence. J Am Coll Cardiol. 2012 Apr 24;59(17):1529-35. doi: 10.1016/j.jacc.2012.01.026.
- Derived from this study: PubMed 31698933Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.
- Individual participant dataSharing planned: No
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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.
Sanjaya Gupta, MD principal investigator
Saint Luke's Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventricular Tachycardia Ablation, Standard Medical Therapy and Non-Invasive Programmed Stimulation (NIPS) in people with Ventricular Tachycardia, run by Saint Luke's Health System 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: stopped early, as of the sponsor's last update on 13 Apr 2023. 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.
Are results available for this study?
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
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?
ICD Shocks (time frame: 12 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 NCT03531502, which also lists 4 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 13 Apr 2023.