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History of Changes for Study: NCT01984346
CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF) (CONVERGE)
Latest version (submitted June 20, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 13, 2013 None (earliest Version on record)
2 December 26, 2013 Recruitment Status, Study Status and Contacts/Locations
3 March 5, 2014 Contacts/Locations and Study Status
4 September 23, 2014 Study Status and Contacts/Locations
5 April 17, 2015 Study Status, Contacts/Locations and Eligibility
6 September 4, 2015 Contacts/Locations and Study Status
7 September 21, 2015 Contacts/Locations and Study Status
8 March 24, 2016 Study Status and Contacts/Locations
9 November 10, 2016 Contacts/Locations and Study Status
10 February 8, 2017 Contacts/Locations, Sponsor/Collaborators, Study Identification, References and Study Status
11 February 17, 2017 Study Status and Contacts/Locations
12 February 23, 2017 Contacts/Locations and Study Status
13 March 28, 2017 Contacts/Locations, Arms and Interventions, Study Status, IPDSharing and Study Description
14 April 6, 2017 Study Status and Contacts/Locations
15 April 26, 2017 Contacts/Locations and Study Status
16 June 19, 2017 Contacts/Locations and Study Status
17 July 21, 2017 Contacts/Locations and Study Status
18 September 14, 2017 Contacts/Locations and Study Status
19 September 20, 2017 Contacts/Locations and Study Status
20 October 12, 2017 Contacts/Locations and Study Status
21 January 8, 2018 Study Status and Contacts/Locations
22 January 31, 2018 Contacts/Locations and Study Status
23 May 31, 2018 Contacts/Locations and Study Status
24 September 21, 2018 Recruitment Status, Study Status, Contacts/Locations, References and Study Design
25 January 6, 2020 Study Status
26 January 13, 2020 Study Status
27 February 7, 2020 Study Status
28 August 25, 2020 Study Status, Arms and Interventions, Study Design
29 August 31, 2020 Arms and Interventions and Study Status
Show
Results Submission Events
30 January 14, 2022 Study Status, Outcome Measures, More Information, Arms and Interventions, Document Section, Adverse Events, Baseline Characteristics, Participant Flow and Study Design
31 March 1, 2022 Outcome Measures and Study Status
32 June 20, 2022 Outcome Measures and Study Status
Comparison Format:

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Study NCT01984346
Submitted Date:  November 13, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: VAL-1200
Brief Title: CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF) (CONVERGE)
Official Title: Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF
Secondary IDs: IDE Number G130084 [CDRH]
Open or close this module Study Status
Record Verification: November 2013
Overall Status: Not yet recruiting
Study Start: December 2013
Primary Completion: June 2016 [Anticipated]
Study Completion: June 2020 [Anticipated]
First Submitted: November 7, 2013
First Submitted that
Met QC Criteria:
November 13, 2013
First Posted: November 14, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 13, 2013
Last Update Posted: November 14, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: nContact Surgical Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).
Detailed Description:
Open or close this module Conditions
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
Convergent Procedure
Combined Epicardial/ Endocardial Ablation
Hybrid Procedure
Radiofrequency Ablation
Arrhythmia
RF Ablation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 153 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Convergent Procedure
Combined Epicardial / Endocardial Ablation
Device: Convergent Procedure EPi-Sense-AF Guided Coagulation System
Combined Epicardial Endocardial Ablation
Other Names:
  • EPi-Sense-AF Guided Coagulation System
Active Comparator: Standalone Endocardial Catheter Ablation
Endocardial Catheter Ablation only
Device: Endocardial Catheter Ablation
Endocardial Catheter Ablation only
Other Names:
  • Irrigated Endocardial Catheters
Open or close this module Outcome Measures
Primary Outcome Measures:
1. AF/AT/Atrial Flutter(AFL) free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage.
[ Time Frame: 12 Months ]

The primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3 month blanking period through the 12 months post procedure follow-up visit.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Age > 18 years; < 80 years
  • Left atrium < 6.0 cm
  • History of AF for ≤ 10 years
  • Refractory or intolerant to one AAD (class I and/or III)
  • Documentation of persistent AF
  • Provided written informed consent

Exclusion Criteria:

  • Patients requiring concomitant surgery
  • Left ventricular ejection fraction < 40%
  • Pregnant or planning to become pregnant during study
  • Co-morbid medical conditions that limit one year life expectancy
  • Previous cardiac surgery
  • History of pericarditis
  • Previous cerebrovascular accident (CVA), excluding fully resolved transient Ischemic attack (TIA)
  • Patients who have active infection or sepsis
  • Patients with esophageal ulcers strictures and varices
  • Patients with renal dysfunction who are not on dialysis
  • Patients who are contraindicated for anticoagulants
  • Patients who are being treated for ventricular arrhythmias
  • Patients who have had a previous left atrial catheter ablation for AF
  • Patients with existing Permanent Pacemakers (PPMs) and Implantable Cardioverter-Defibrillator (ICDs)
  • Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
  • Not competent to legally represent him or herself
Open or close this module Contacts/Locations
Central Contact Person: Jagruti Vyas, BS
Telephone: 919-655-1354
Email: jvyas@ncontactinc.com
Central Contact Backup: James G Whayne, MS
Telephone: 919-655-1561
Email: jwhayne@ncontactinc.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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