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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

Tracking Information
First Submitted Date  ICMJE July 25, 2022
First Posted Date  ICMJE July 28, 2022
Last Update Posted Date April 23, 2024
Actual Study Start Date  ICMJE March 17, 2023
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2023)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2022)
Freedom from AF [ Time Frame: 1 year ]
Freedom from recurrent AF at 1 year after 1 study redo procedure
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion
Official Title  ICMJE Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Device: Catheter Ablation
Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical).
Study Arms  ICMJE Experimental: Treatment Group
Patients undergoing catheter ablation that qualify after initial screening.
Intervention: Device: Catheter Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2022)
92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05477147
Other Study ID Numbers  ICMJE CLIPL-01-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Volta Medical
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Volta Medical
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Volta Medical
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP