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Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion (RESTART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05477147
Recruitment Status : Active, not recruiting
First Posted : July 28, 2022
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Volta Medical

Study Description
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Brief Summary:
Multi-center, international, non-randomized clinical trial evaluating the use of Volta's VX1 algorithm as used in combination with repeat catheter ablation after AF recurrence after previous catheter ablation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Catheter Ablation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion
Actual Study Start Date : March 17, 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group
Patients undergoing catheter ablation that qualify after initial screening.
 Device: Catheter Ablation
Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical).


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from AF [ Time Frame: 1 year ]
    Percent of patient free from recurrent AF episodes of >30 seconds at 1 year after 1 study redo procedure


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 21 years of age or older indicated for redo AF ablation
  2. Previous catheter or surgical ablation for paroxysmal AF, persistent AF, or long-standing persistent AF
  3. Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure
  4. Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
  5. Patients must be able and willing to provide written informed consent to participate in the clinical trial

Exclusion Criteria:

  1. Previous ablation procedure-related complication (e.g. fistula, perforation, etc.)
  2. First AF ablation procedure indication was persistent AF lasting longer than 24 months
  3. Long-standing persistent AF recurrence prior to study redo procedure
  4. Previous AF ablation using VX1 software
  5. Severe obesity (BMI > 50)
  6. Very dilated Left Atrium (LA) (e.g. LA diameter > 55 mm and/or LA surface > 40 cm2 determined by 2D echocardiography)
  7. Patients with AF secondary to an obvious reversible cause
  8. Inadequate anticoagulation as defined in the inclusion criteria
  9. LA thrombus on Transesophageal Echocardiography (TEE)* or CT Scan prior to procedure
  10. Contraindications to anticoagulation (heparin, warfarin or NOAC)
  11. Patients who are or may potentially be pregnant
  12. Any cardiac surgery except catheter ablation within the past 2 months (60 days) (includes PCI)
  13. Myocardial infarction within the past 2 months (60 days)
  14. Previous AV valve surgery
  15. Patient diagnosed with hypertrophic cardiomyopathy
  16. History of blood clotting or bleeding abnormalities
  17. Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
  18. Rheumatic Heart Disease
  19. Cardiac Sarcoidosis
  20. Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)
  21. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
  22. Unstable angina within the past month
  23. Acute illness or active systemic infection or sepsis
  24. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  25. Diagnosed atrial myxoma
  26. Significant severe pulmonary disease (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
  27. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
  28. Enrollment in an investigational study evaluating another device, biologic, or drug
  29. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
  30. Life expectancy or other disease processes likely to limit survival to less than 12 months
  31. Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05477147


Locations
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United States, Florida
Ascension St. Vincent's Hospital
Jacksonville, Florida, United States, 32204
United States, Kansas
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, United States, 66211
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63130
United States, New York
Northwell Health System
New York, New York, United States, 11030
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22042
Belgium
OLV Aalst
Aalst, Belgium
France
Hôpital Privé Jacques Cartier
Massy, France
Clinique Pasteur
Toulouse, France
Sponsors and Collaborators
Volta Medical
More Information
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Responsible Party: Volta Medical
ClinicalTrials.gov Identifier: NCT05477147    
Other Study ID Numbers: CLIPL-01-003
First Posted: July 28, 2022    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Volta Medical:
Atrial fibrillation
AF
Artificial intelligence
Catheter Ablation
Ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes