Ventricular TachycardiaRESET-VTNCT01858194
REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
A study testing Renal sympathetic denervation and VT ablation alone in people with Ventricular Tachycardia, run by Vivek Reddy at 2 sites in 2 countries.
Trial summary
Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of recurrent VT following catheter ablation remains unclear. 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?
- Renal sympathetic denervation and VT ablation alone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2013to 1 Sep 2017
- 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
- ≥ 18 years of age
- Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.)
- Planned for catheter-based ablation of VT
- All patients will have an existing ICD
- 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
- MI or CVA within 30 days
- Coronary Artery Bypass Graft (CABG) within 30 days of this procedure
- Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis)
- GFR <30 ml/min (unless receiving dialysis)
- Life expectancy <1 year for any medical condition
- Any condition resulting in a contraindication to anticoagulation (e.g. GI bleeding)
- Inability to give informed consent
- Known pregnancy or positive -HCG within 7 days of procedure.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of recurrent VT following catheter ablation 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 and promoting ventricular remodeling. 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 prevention of recurrent VT in patients following catheter ablation of VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT ablation.
Read the detailed description
The goal of this trial is to test the impact of catheter-based renal sympathetic denervation (RSDN) as an adjunctive treatment for patients with either ischemic or non-ischemic cardiomyopathy undergoing catheter ablation of ventricular tachycardia (VT). The proposed study is a prospective, multicenter, randomized control trial. Patients undergoing VT ablation will be randomized to either VT ablation alone or VT ablation + RSDN.
- Conditions
- Ventricular Tachycardia
- Being tested
- Renal sympathetic denervation, VT ablation alone
- Keywords
- Tachycardia, Renal Sympathetic Denervation, Catheter Ablation, Cardioverter-Defibrillator
- Medical subject headings
- Tachycardia, Ventricular, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal sympathetic denervationDevice
Also called Ablation Arm, Catheter-based Renal Sympathetic Denervation
- The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation.
- After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).
VT ablation aloneDevice
Placebo arm will receive standard VT ablation using current techniques
| Study group | Role | What they receive |
|---|---|---|
| Renal sympathetic denervation | Experimental | Catheter-based Renal Sympathetic Denervation Ablation Arm Receives: Device: Renal sympathetic denervation |
| VT ablation alone | Placebo comparator | No further therapy in addition to VT ablation Receives: Device: VT ablation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From First Event Requiring ICD Therapy
Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months
Measured: 24 months
Secondary outcomes (17)
Number of Appropriate ICD Shocks for Ventricular Arrhythmia
An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
Measured: at 24 months
Number of Inappropriate ICD Therapy
Number of inappropriate ICD therapy including both appropriate and inappropriate shocks
Measured: at 24 months
All ICD Therapies (Appropriate + Inappropriate)
cumulative ICD therapies including both appropriate and inappropriate shocks
Measured: 24 months
Number of Participants With Mortality, ICD Storm and Incessant VT
Number of Participants with a composite of Mortality, ICD storm, and Incessant VT
Measured: 24 months
Number of Participants With Hospitalizations for Cardiovascular Causes
Measured: 24 months
Number of Episodes of Total VT Burden
Total VT burden (Number of episodes)
Measured: at 24 months
Number of Participants With All-Cause Mortality
Measured: 24 months
Number of Participants With Occurrences of ICD Storm
The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours.
Measured: 24 months
Change in Brain Natriuretic Peptide (BNP)
Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline.
Measured: at baseline and at 12 months
Differences in BUN/Creatinine Measurements
Differences in BUN/creatinine measurements compared at 12 months to baseline.
Measured: baseline and 12 months
Change in LV Size
LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline
Measured: baseline and 12 months
Number of Procedure-related Adverse Events
Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms, renal artery stenosis, renal impairment, thromboembolic events, stroke, pericardial bleeding including tamponade and myocardial infarction.
Measured: 24 months
Changes in Mean Arterial Pressure
Change in mean arterial pressure
Measured: baseline and 24 months
Number of Participants With Orthostatic Hypertension
Number of participants with other individual complication rates specifically orthostatic hypertension
Measured: 24 months
Number of Participants With Other Complications
Other individual complication rates including, but not limited to MI and death
Measured: at 24 months
Number of Occurrences of Major Complication Rate
30-day Major Complication Rate defined as death, stroke, 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: 30 days
Procedure Time
Renal Denervation Procedure time
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMar 2013
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
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
- 21 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 Y Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858194
- Sponsor's protocol ID
- GCO 13-1462
- Acronym
- RESET-VT
- Status last verified
- Apr 2020
- First submitted
- 19 Mar 2013
- Last updated
- 17 Apr 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 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
- ClinicalTrials.gov ID
- NCT01858194
- Acronym / sponsor ID
- RESET-VT / GCO 13-1462
- Conditions
- Ventricular Tachycardia
- Keywords
- Tachycardia, Renal Sympathetic Denervation, Catheter Ablation, Cardioverter-Defibrillator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Posted 17 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of recurrent VT following catheter ablation 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 and promoting ventricular remodeling. 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 prevention of recurrent VT in patients following catheter ablation of VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT ablation.
Detailed description
The goal of this trial is to test the impact of catheter-based renal sympathetic denervation (RSDN) as an adjunctive treatment for patients with either ischemic or non-ischemic cardiomyopathy undergoing catheter ablation of ventricular tachycardia (VT). The proposed study is a prospective, multicenter, randomized control trial. Patients undergoing VT ablation will be randomized to either VT ablation alone or VT ablation + RSDN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal sympathetic denervation | Experimental | Device: Renal sympathetic denervationCatheter-based Renal Sympathetic Denervation Ablation Arm |
| VT ablation alone | Placebo comparator | Device: VT ablation aloneNo further therapy in addition to VT ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age
- Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.)
- Planned for catheter-based ablation of VT
- All patients will have an existing ICD
- Accessibility of renal vasculature (determined by renal angiography)
Key exclusion criteria (8 listed)
- MI or CVA within 30 days
- Coronary Artery Bypass Graft (CABG) within 30 days of this procedure
- Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis)
- GFR <30 ml/min (unless receiving dialysis)
- Life expectancy <1 year for any medical condition
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 |
|---|---|---|
| Renal sympathetic denervationAlso: Ablation Arm, Catheter-based Renal Sympathetic Denervation* The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. * After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion). | Device | Renal sympathetic denervation |
| VT ablation alonePlacebo arm will receive standard VT ablation using current techniques | Device | VT ablation alone |
Primary outcome
Freedom From First Event Requiring ICD Therapy
Time frame: 24 months
Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months
17 secondary outcomes
Number of Appropriate ICD Shocks for Ventricular Arrhythmia
Time frame: at 24 months
Number of Inappropriate ICD Therapy
Time frame: at 24 months
All ICD Therapies (Appropriate + Inappropriate)
Time frame: 24 months
Number of Participants With Mortality, ICD Storm and Incessant VT
Time frame: 24 months
Number of Participants With Hospitalizations for Cardiovascular Causes
Time frame: 24 months
Number of Episodes of Total VT Burden
Time frame: at 24 months
Number of Participants With All-Cause Mortality
Time frame: 24 months
Number of Participants With Occurrences of ICD Storm
Time frame: 24 months
Change in Brain Natriuretic Peptide (BNP)
Time frame: at baseline and at 12 months
Differences in BUN/Creatinine Measurements
Time frame: baseline and 12 months
Change in LV Size
Time frame: baseline and 12 months
Number of Procedure-related Adverse Events
Time frame: 24 months
Changes in Mean Arterial Pressure
Time frame: baseline and 24 months
Number of Participants With Orthostatic Hypertension
Time frame: 24 months
Number of Participants With Other Complications
Time frame: at 24 months
Number of Occurrences of Major Complication Rate
Time frame: 30 days
Procedure Time
Time frame: during procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
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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 Y Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal sympathetic denervation and VT ablation alone in people with Ventricular Tachycardia, run by Vivek Reddy at 2 sites in 2 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 7 inclusion and 8 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 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Czechia. 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. Some participants in this study may receive a placebo. 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 17 Apr 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?
Freedom From First Event Requiring ICD Therapy (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 17 Apr 2020.