Ventricular TachycardiaRESCUENCT01747837
REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients
A study testing Boston Scientific Vessix Renal Denervation System in people with Ventricular Tachycardia, run by Vivek Reddy at 4 sites in 3 countries.
Trial summary
The objective of this trial is to determine the efficacy and safety of adjunctive catheter-based renal sympathetic denervation (RSDN) in the primary prevention of implantable cardioverter defibrillator (ICD) therapy in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD for either… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Boston Scientific Vessix Renal Denervation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 22 Oct 2015to 9 Jan 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, etc.)
- Planned for ICD implantation for:
- i. Secondary prevention (eg: VT/VF arrest, sustained VT, syncope/inducible VT)
- ii. Primary prevention + inducible MMVT during induction via ICD lead testing
- Accessibility of renal vasculature (determined by renal angiography)
- Ability to understand the requirements of the study
- Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements
Who cannot join
- Patient taking a Class I or III antiarrhythmic drug.
- Planned to undergo a cardiac VT ablation procedure
- NYHA Class IV Congestive Heart Failure
- MI within 30 days
- Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
- Baseline orthostatic hypotension
Show all 10Show fewer
- End stage renal failure on dialysis
- Life expectancy <1 year for any medical condition
- Known pregnancy or positive β-HCG within 7 days of procedure.
- Coronary Artery Bypass Graft (CABG) within 30 days of the procedure
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Texas Cardiac
Austin, Texas, 78705
Mount Sinai Hospital
New York, New York, 10029
Russia1 site
Academician E.N. Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
Novosibirsk
About this study
The objective of this trial is to determine the efficacy and safety of adjunctive catheter-based renal sympathetic denervation (RSDN) in the primary prevention of implantable cardioverter defibrillator (ICD) therapy in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD for either i) secondary prevention, or ii) primary prevention + inducible ventricular tachycardia (VT) by programmed ventricular stimulation at the time of ICD implantation. These patients will be randomized to ICD alone or ICD + RSDN.
Read the detailed description
Rationale for this Study
Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, anti-arrhythmic drugs (AADs), and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of ICD shocks remains unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the renin-angiotensin-aldosterone system. Although RSDN has been shown to reduce the recurrence of VT in a case report of 2 patients suffering from electrical storm, to date no large prospective randomized study has evaluated the impact of RSDN in the primary prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction. Also of note, there is data suggesting that RSDN may even decrease the rate of supraventricular arrhythmias such as atrial fibrillation. Thus, RESCUE will specifically evaluate the safety and efficacy of RSDN in the prevention of ICD therapy in patients with ventricular dysfunction who are to receive an ICD for either secondary prevention, or primary prevention if they have inducible VT by programmed ventricular stimulation at the time of ICD implantation.
Description of Procedures
Screening:
To take part in this study, you must meet all study requirements. The screening visit tests and procedures are done to see if you are eligible to be in the study. The study doctor will review these with you and let you know if you qualify. The study doctor will make a final decision about your possible study qualification.
Pre-randomization Procedures:
After providing written consent the following data will be collected and examinations and tests performed:
- A physical examination
- Your blood pressure will be taken
- A review of your medical history and what medications you are taking
- A blood sample will be drawn for routine laboratory tests.
- Women who can have children will take a urine pregnancy test. The test must be negative for you to be in this study.
- A Transthoracic Echocardiogram (TTE)-a non-invasive test where a probe is placed on the chest wall and images are taken through the chest wall of the heart valves and heart muscle, that will measure the left ventricular size (heart wall thickness) and mitral inflow (flow of blood through the heart valve).
- An ICD interrogation (if you already have an ICD implanted) - a non-invasive test where a device is placed over the chest wall near your ICD, and data is transmitted wirelessly from your ICD to a laptop for your physician to review.
- An electrocardiogram (EKG) - a non-invasive test where several probes are placed on the chest wall that will measure electrical activity in your heart.
Randomization:
Immediately following the catheter ablation, patients will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney. The study doctor will assess whether the renal arteries are suitable to receive catheter-based renal denervation. Once you agree to participate in this study, by signing this informed consent, and are it is determined that you are eligible to participate you will be randomized to one of two treatment groups immediately following the renal angiogram.
Randomization means that you are put into a group by chance. It is like flipping a coin. You will have an equal chance (50%) of being placed in either group. This study design is single-blinded; you will not know ahead of time which group you will be in. Only your physician will know which group you are randomized to.
If you do not already have an ICD, you will undergo ICD placement as part of routine clinical care. You may undergo ICD placement up to 1 month (30 days) before randomization. An ICD (implantable cardioverter-defibrillator) is a small battery-powered electrical impulse generator which is implanted in patients who are at risk of sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. The device is programmed to detect abnormal heart beats (cardiac arrhythmia) and correct it by delivering a jolt of electricity.
The first group will undergo catheter-based sympathetic renal denervation. Renal Sympathetic Denervation is a procedure that uses a catheter probe inserted into the renal (kidney) artery that deactivates the nerves that are linked to high blood pressure.
The second group (control group) will receive no further intervention after ICD implantation.
- Conditions
- Ventricular Tachycardia
- Being tested
- Boston Scientific Vessix Renal Denervation System
- Keywords
- Renal sympathetic denervation, Renal catheter ablation, Ventricular tachycardia
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific Vessix Renal Denervation SystemDevice
Also called Renal sympathetic denervation, Renal denervation, Denervation
Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
| Study group | Role | What they receive |
|---|---|---|
| standard ICD implantation alone | No intervention | These subjects will undergo standard ICD implantation alone (if not already present) |
| Boston Scientific Vessix Renal Denervation System | Experimental | These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.
Ablation arm Receives: Device: Boston Scientific Vessix Renal Denervation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Event Requiring ICD Therapy or Incessant VT
The primary endpoint of this study is the time to first event requiring implantable cardioverter defibrillator (ICD) therapy or Incessant VT. (Ventricular tachycardia (VT) occurring below the ICD rate cut-off); this will be assessed in the on-treatment patient cohort. An event requiring ICD therapy is defined as an anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
Measured: 24 months
Secondary outcomes (11)
Number of Occurrences of Appropriate ICD Therapy
Number of Occurrences of Appropriate ICD therapy assessed in the full intention-to-treat patient cohort. An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
Measured: 24 months
Number of Occurrences of Inappropriate ICD Therapy
Number of occurrences of inappropriate shocks. Inappropriate ICD therapy are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing.
Measured: 24 months
Number of Hospitalizations for Cardiovascular Causes
Cumulative number of Hospitalizations for Cardiovascular Causes
Measured: 24 months
Number of Episodes of Total VT Burden
Cumulative Number of episodes of Total VT burden
Measured: 24 months
All-Cause Mortality
All-Cause Mortality
Measured: 24 months
Number of Occurrence of ICD Storm
The cumulative number of occurrences of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours
Measured: 24 months
BUN Measurements
Blood Urea Nitrogen (BUN) measurements
Measured: baseline, 6 months, 12 months, 24 months
Creatinine Measurements
Creatinine measurements
Measured: baseline, 6 months, 12 months, 24 months
Procedure Related Adverse Events
Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis.
Measured: 24 months
Number of Participants With Orthostatic Hypotension
Number of participants who developed of orthostatic hypotension
Measured: 24 months
Number of Participants With Major Complication
Number of Participants with Major Complication defined as death, stroke, myocardial infarction (MI) or any other serious adverse events related to the treatment or procedure within the first 30 days or through hospital discharge (whichever is longer)
Measured: average 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study start22 Oct 2015
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747837
- Sponsor's protocol ID
- 12-02-213
- Acronym
- RESCUE
- Status last verified
- Feb 2020
- First submitted
- 1 Nov 2012
- Last updated
- 4 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients
- ClinicalTrials.gov ID
- NCT01747837
- Acronym / sponsor ID
- RESCUE / 12-02-213
- Conditions
- Ventricular Tachycardia
- Keywords
- Renal sympathetic denervation, Renal catheter ablation, Ventricular tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to determine the efficacy and safety of adjunctive catheter-based renal sympathetic denervation (RSDN) in the primary prevention of implantable cardioverter defibrillator (ICD) therapy in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD for either i) secondary prevention, or ii) primary prevention + inducible ventricular tachycardia (VT) by programmed ventricular stimulation at the time of ICD implantation. These patients will be randomized to ICD alone or ICD + RSDN.
Detailed description
Rationale for this Study
Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, anti-arrhythmic drugs (AADs), and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of ICD shocks remains unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the renin-angiotensin-aldosterone system. Although RSDN has been shown to reduce the recurrence of VT in a case report of 2 patients suffering from electrical storm, to date no large prospective randomized study has evaluated the impact of RSDN in the primary prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction. Also of note, there is data suggesting that RSDN may even decrease the rate of supraventricular arrhythmias such as atrial fibrillation. Thus, RESCUE will specifically evaluate the safety and efficacy of RSDN in the prevention of ICD therapy in patients with ventricular dysfunction who are to receive an ICD for either secondary prevention, or primary prevention if they have inducible VT by programmed ventricular stimulation at the time of ICD implantation.
Description of Procedures
Screening:
To take part in this study, you must meet all study requirements. The screening visit tests and procedures are done to see if you are eligible to be in the study. The study doctor will review these with you and let you know if you qualify. The study doctor will make a final decision about your possible study qualification.
Pre-randomization Procedures:
After providing written consent the following data will be collected and examinations and tests performed:
- A physical examination
- Your blood pressure will be taken
- A review of your medical history and what medications you are taking
- A blood sample will be drawn for routine laboratory tests.
- Women who can have children will take a urine pregnancy test. The test must be negative for you to be in this study.
- A Transthoracic Echocardiogram (TTE)-a non-invasive test where a probe is placed on the chest wall and images are taken through the chest wall of the heart valves and heart muscle, that will measure the left ventricular size (heart wall thickness) and mitral inflow (flow of blood through the heart valve).
- An ICD interrogation (if you already have an ICD implanted) - a non-invasive test where a device is placed over the chest wall near your ICD, and data is transmitted wirelessly from your ICD to a laptop for your physician to review.
- An electrocardiogram (EKG) - a non-invasive test where several probes are placed on the chest wall that will measure electrical activity in your heart.
Randomization:
Immediately following the catheter ablation, patients will undergo a renal angiogram in order to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities that could be affecting the blood supply to the kidney. It is performed by injecting contrast dye through a catheter (a tiny tube) into the blood vessels of the kidney. The study doctor will assess whether the renal arteries are suitable to receive catheter-based renal denervation. Once you agree to participate in this study, by signing this informed consent, and are it is determined that you are eligible to participate you will be randomized to one of two treatment groups immediately following the renal angiogram.
Randomization means that you are put into a group by chance. It is like flipping a coin. You will have an equal chance (50%) of being placed in either group. This study design is single-blinded; you will not know ahead of time which group you will be in. Only your physician will know which group you are randomized to.
If you do not already have an ICD, you will undergo ICD placement as part of routine clinical care. You may undergo ICD placement up to 1 month (30 days) before randomization. An ICD (implantable cardioverter-defibrillator) is a small battery-powered electrical impulse generator which is implanted in patients who are at risk of sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. The device is programmed to detect abnormal heart beats (cardiac arrhythmia) and correct it by delivering a jolt of electricity.
The first group will undergo catheter-based sympathetic renal denervation. Renal Sympathetic Denervation is a procedure that uses a catheter probe inserted into the renal (kidney) artery that deactivates the nerves that are linked to high blood pressure.
The second group (control group) will receive no further intervention after ICD implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard ICD implantation alone | No intervention | –These subjects will undergo standard ICD implantation alone (if not already present) |
| Boston Scientific Vessix Renal Denervation System | Experimental | Device: Boston Scientific Vessix Renal Denervation SystemThese subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation. Ablation arm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years of age
- Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, etc.)
- Planned for ICD implantation for:
- Accessibility of renal vasculature (determined by renal angiography)
- Ability to understand the requirements of the study
Key exclusion criteria (10 listed)
- Patient taking a Class I or III antiarrhythmic drug.
- Planned to undergo a cardiac VT ablation procedure
- NYHA Class IV Congestive Heart Failure
- MI within 30 days
- Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
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 |
|---|---|---|
| Boston Scientific Vessix Renal Denervation SystemAlso: Renal sympathetic denervation, Renal denervation, DenervationRenal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation. Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts | Device | Boston Scientific Vessix Renal Denervation System |
Primary outcome
Time to First Event Requiring ICD Therapy or Incessant VT
Time frame: 24 months
The primary endpoint of this study is the time to first event requiring implantable cardioverter defibrillator (ICD) therapy or Incessant VT. (Ventricular tachycardia (VT) occurring below the ICD rate cut-off); this will be assessed in the on-treatment patient cohort. An event requiring ICD therapy is defined as an anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
11 secondary outcomes
Number of Occurrences of Appropriate ICD Therapy
Time frame: 24 months
Number of Occurrences of Inappropriate ICD Therapy
Time frame: 24 months
Number of Hospitalizations for Cardiovascular Causes
Time frame: 24 months
Number of Episodes of Total VT Burden
Time frame: 24 months
All-Cause Mortality
Time frame: 24 months
Number of Occurrence of ICD Storm
Time frame: 24 months
BUN Measurements
Time frame: baseline, 6 months, 12 months, 24 months
Creatinine Measurements
Time frame: baseline, 6 months, 12 months, 24 months
Procedure Related Adverse Events
Time frame: 24 months
Number of Participants With Orthostatic Hypotension
Time frame: 24 months
Number of Participants With Major Complication
Time frame: average 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific Vessix Renal Denervation System in people with Ventricular Tachycardia, run by Vivek Reddy at 4 sites in 3 countries.
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 8 inclusion and 10 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 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Czechia, Russia. 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 27 Jan 2020). 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?
Time to First Event Requiring ICD Therapy or Incessant VT (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.