An interventional study of Renal sympathetic denervation and VT ablation alone in Ventricular Tachycardia, sponsored by Vivek Reddy. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by Vivek Reddy · Not applicable, Interventional, and Treatment
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.
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.
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's enrollment of 21 is below the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →Vivek Reddy is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Catheter-based Renal Sympathetic Denervation Ablation Arm
Device: Renal sympathetic denervation
No further therapy in addition to VT ablation
Device: VT ablation alone
* 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).
Also known as: Ablation Arm, Catheter-based Renal Sympathetic Denervation
Placebo arm will receive standard VT ablation using current techniques
Freedom From First Event Requiring ICD Therapy
Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months
Time frame: 24 months
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.
Time frame: at 24 months
Number of Inappropriate ICD Therapy
Number of inappropriate ICD therapy including both appropriate and inappropriate shocks
Time frame: at 24 months
All ICD Therapies (Appropriate + Inappropriate)
cumulative ICD therapies including both appropriate and inappropriate shocks
Time frame: 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
Time frame: 24 months
Number of Participants With Hospitalizations for Cardiovascular Causes
Time frame: 24 months
Number of Episodes of Total VT Burden
Total VT burden (Number of episodes)
Time frame: at 24 months
Number of Participants With All-Cause Mortality
Time frame: 24 months
Number of Participants With Occurrences of ICD Storm
The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours.
Time frame: 24 months
Change in Brain Natriuretic Peptide (BNP)
Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline.
Time frame: at baseline and at 12 months
Differences in BUN/Creatinine Measurements
Differences in BUN/creatinine measurements compared at 12 months to baseline.
Time frame: baseline and 12 months
Change in LV Size
LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline
Time frame: 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.
Time frame: 24 months
Changes in Mean Arterial Pressure
Change in mean arterial pressure
Time frame: baseline and 24 months
Number of Participants With Orthostatic Hypertension
Number of participants with other individual complication rates specifically orthostatic hypertension
Time frame: 24 months
Number of Participants With Other Complications
Other individual complication rates including, but not limited to MI and death
Time frame: 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)
Time frame: 30 days
Procedure Time
Renal Denervation Procedure time
Time frame: during procedure
21 participants received ID numbers because they were consented. 3 patients were screen failures due to accessibility of renal vasculature and Investigator discretion. 1 patient was a non-randomized roll- in where data was not collected.
| Milestone | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Started | 8 | 9 |
| Completed | 8 | 7 |
| Not completed | 0 | 2 |
| Withdrew: Total artificial heart implant | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months
| probability of freedom | Renal Sympathetic Denervation | VT Ablation Alone |
|---|---|---|
| 12 months | 62.5 | 50 |
| 24 months | 62.5 | 37.5 |
An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
| occurrences | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Appropriate ICD Shocks for Ventricular Arrhythmia | 7 | 12 |
Number of inappropriate ICD therapy including both appropriate and inappropriate shocks
| occurrences | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Inappropriate ICD Therapy | 5 | 7 |
cumulative ICD therapies including both appropriate and inappropriate shocks
| occurrences | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| All ICD Therapies (Appropriate + Inappropriate) | 32 | 32 |
Number of Participants with a composite of Mortality, ICD storm, and Incessant VT
| Participants | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Participants With Mortality, ICD Storm and Incessant VT | 1 | 3 |
| Participants | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Participants With Hospitalizations for Cardiovascular Causes | 3 | 1 |
Total VT burden (Number of episodes)
| episodes | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Episodes of Total VT Burden | 20 | 12 |
| Participants | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Participants With All-Cause Mortality | 0 | 0 |
The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours.
| Participants | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Participants With Occurrences of ICD Storm | 1 | 3 |
Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline.
| mg/dL | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Change in Brain Natriuretic Peptide (BNP) | -12.33 ± 46.6 | -2.5 ± 24.75 |
Differences in BUN/creatinine measurements compared at 12 months to baseline.
| mg/dL | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| BUN | -4 ± 4.84 | 1.67 ± 5.68 |
| Creatinine | 0.095 ± 0.24 | .04 ± .03 |
LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline
| cm | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Change in LV Size | -.125 ± .59 | -1.4 ± NA |
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.
| events | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Procedure-related Adverse Events | 3 | 3 |
Change in mean arterial pressure
| mmHg | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Changes in Mean Arterial Pressure | 3.33 ± 8.41 | 13.77 ± 18.75 |
Number of participants with other individual complication rates specifically orthostatic hypertension
| Participants | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Participants With Orthostatic Hypertension | 0 | 0 |
Other individual complication rates including, but not limited to MI and death
| Participants | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Participants With Other Complications | 1 | 2 |
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)
| occurrences | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Number of Occurrences of Major Complication Rate | 2 | 3 |
Renal Denervation Procedure time
| minutes | VT Ablation Alone | Renal Sympathetic Denervation |
|---|---|---|
| Procedure Time | — | 27.83 ± 8.8 |
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Renal Sympathetic Denervation | 0/9 (0%) | 3/9 (33.3%) | 5/9 (55.6%) |
| VT Ablation Alone | 0/8 (0%) | 2/8 (25%) | 3/8 (37.5%) |
| Event | Renal Sympathetic Denervation | VT Ablation Alone |
|---|---|---|
| VT recurrenceCardiac disorders | 0/9 | 2/8 |
| Non-sustained VTCardiac disorders | 0/9 | 1/8 |
| PneumoniaInfections and infestations | 0/9 | 1/8 |
| MacrohematuriaRenal and urinary disorders | 0/9 | 1/8 |
| AF with urosepsisGeneral disorders | 1/9 | 0/8 |
| Worsening heart failure/Total artifical heart implantCardiac disorders | 1/9 | 0/8 |
| Pseudoaneurysm at septal aspect of LV apexCardiac disorders | 1/9 | 0/8 |
| Event | Renal Sympathetic Denervation | VT Ablation Alone |
|---|---|---|
| VT recurrenceCardiac disorders | 0/9 | 2/8 |
| Dissection of left external iliac arteryCardiac disorders | 0/9 | 1/8 |
| ParesthesiaSkin and subcutaneous tissue disorders | 0/9 | 1/8 |
| LUE Cephalic vein thrombosisVascular disorders | 1/9 | 0/8 |
| Hypotension with pleuritic chest painCardiac disorders | 1/9 | 0/8 |
| Kidney pain with near syncopeHepatobiliary disorders | 1/9 | 0/8 |
| FluInfections and infestations | 1/9 | 0/8 |
| Bradycardia associated with dyspnea on exertionCardiac disorders | 1/9 | 0/8 |
| Jaw painMusculoskeletal and connective tissue disorders | 1/9 | 0/8 |
| Age, Continuous(years) | VT Ablation Alone | Renal Sympathetic Denervation | Total |
|---|---|---|---|
| Mean | 61.5 ± 8.73 | 56.78 ± 9.43 | 58.88 ± 9.12 |
| Sex: Female, Male(Participants) | VT Ablation Alone | Renal Sympathetic Denervation | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 7 | 8 | 15 |
| Ethnicity (NIH/OMB)(Participants) | VT Ablation Alone | Renal Sympathetic Denervation | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 7 | 6 | 13 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | VT Ablation Alone | Renal Sympathetic Denervation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 3 | 7 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
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Vivek Reddy