Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Edward Gerstenfeld, MD
Headshot of Edward Gerstenfeld
Edward Gerstenfeld

Description

Summary

The objective of this clinical study is to evaluate the safety and performance of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic VT (SMVT)

Details

A prospective, single-arm, multi-center, open label, pre-market, early feasibility clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of SMVT. Study subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation. Study subjects must have an Implantable Cardioverter Defibrillator (ICD) prior to the cryoablation procedure.

Keywords

Sustained VT, cryoablation, monomorphic VT, sustained monomorphic VT, Tachycardia, Ventricular Tachycardia, cryoablation procedure, VT Cryoablation

Eligibility

You can join if…

Open to people ages 18 years and up

(IC):

  • IC 1 Male or female ≥ 18 years
  • IC 2 Patients with a clinical indication for a catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained monomorphic Ventricular Tachycardia
  • IC 3 Has received an ICD prior to enrollment
  • IC 4 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months
  • IC 5 Refractory to, or intolerant of, at least one Class III AAD
  • IC 6 Subject has LVEF ≥ 20%, confirmed by echo or comparable technique during baseline evaluation or in the previous three months
  • IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study
  • IC 8 Willingness and ability to give an informed consent

You CAN'T join if...

(EC):

  • EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure
  • EC 2 Idiopathic VT
  • EC 3 Any VT ablation within 4 weeks prior to enrollment
  • EC 4 More than one prior (>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years
  • EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
  • EC 6 Cardiogenic shock, unless it is due to incessant monomorphic VT
  • EC 7 Structural heart disease as described below:
  • Class IV heart failure
  • Aortic aneurysm
  • Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure
  • Interatrial baffle, closure device, patch, or PFO occlusion device
  • Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
  • Acute MI or unstable angina in the previous 60 days
  • Mechanical mitral or aortic valve
  • Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
  • Cardiac myxoma
  • . Significant congenital heart disease
  • EC 8 Acute illness or active systemic infection
  • EC 9 Any previous history of cryoglobulinemia
  • EC 10 History of blood clotting or bleeding disease
  • EC 11 Peripheral vascular disease that precludes LV access
  • EC 12 Contraindication to heparin
  • EC 13 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure
  • EC 14 Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure.
  • EC 15 Pregnant, or anticipated pregnancy during study follow-up
  • EC 16 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study
  • EC 17 Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, candidate for heart transplantation, patient with ventricular assist device, or terminal illness with a life expectancy less than 12 months)

Locations

  • University of California San Francisco
    San Francisco California 94143 United States
  • Banner University Medical Center Phoenix
    Phoenix Arizona 85006 United States

Lead Scientist at UCSF

  • Edward Gerstenfeld, MD
    Dr Gerstenfeld is the Melvin Scheinman Endowed Professor of Medicine and Chief of the Section of Cardiac Electrophysiology at UCSF.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Adagio Medical
ID
NCT05675865
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated