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Completed

NCT Number: NCT01858194

REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation

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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Homolka Hospital, Prague, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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

Exclusion criteria

  • 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.

Treatment and study plan

Renal Sympathetic Denervation

Device
  • 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).

Other names: Ablation Arm, Catheter-based Renal Sympathetic Denervation

VT ablation alone

Device

Placebo arm will receive standard VT ablation using current techniques

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Appropriate ICD Shocks for Ventricular Arrhythmia

    Time frame: at 24 months

    An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.

  2. Number of Inappropriate ICD Therapy

    Time frame: at 24 months

    Number of inappropriate ICD therapy including both appropriate and inappropriate shocks

  3. All ICD Therapies (Appropriate + Inappropriate)

    Time frame: 24 months

    cumulative ICD therapies including both appropriate and inappropriate shocks

  4. Number of Participants With Mortality, ICD Storm and Incessant VT

    Time frame: 24 months

    Number of Participants with a composite of Mortality, ICD storm, and Incessant VT

  5. Number of Participants With Hospitalizations for Cardiovascular Causes

    Time frame: 24 months

  6. Number of Episodes of Total VT Burden

    Time frame: at 24 months

    Total VT burden (Number of episodes)

  7. Number of Participants With All-Cause Mortality

    Time frame: 24 months

  8. Number of Participants With Occurrences of ICD Storm

    Time frame: 24 months

    The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours.

  9. Change in Brain Natriuretic Peptide (BNP)

    Time frame: at baseline and at 12 months

    Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline.

  10. Differences in BUN/Creatinine Measurements

    Time frame: baseline and 12 months

    Differences in BUN/creatinine measurements compared at 12 months to baseline.

  11. Change in LV Size

    Time frame: baseline and 12 months

    LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline

  12. Number of Procedure-related Adverse Events

    Time frame: 24 months

    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.

  13. Changes in Mean Arterial Pressure

    Time frame: baseline and 24 months

    Change in mean arterial pressure

  14. Number of Participants With Orthostatic Hypertension

    Time frame: 24 months

    Number of participants with other individual complication rates specifically orthostatic hypertension

  15. Number of Participants With Other Complications

    Time frame: at 24 months

    Other individual complication rates including, but not limited to MI and death

  16. Number of Occurrences of Major Complication Rate

    Time frame: 30 days

    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)

  17. Procedure Time

    Time frame: during procedure

    Renal Denervation Procedure time

Sponsors and collaborators

Lead sponsor

Vivek Reddy

Other

Registry information

Acronym: RESET-VT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 21, 2013
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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