The Dynamics of Human Atrial Fibrillation

NCT01008722 | Completed Results

• 2 other identifiers: 684R01HL083359
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 2

Brief Summary

The study is conducted in patients with atrial fibrillation undergoing clinically prescribed ablation. The study hypothesis is that ablation at specific sites that are identified to 'drive' the atrial fibrillation may improve the success of the ablation procedure.

Conditions

Atrial Fibrillation; Atrial Tachyarrhythmia

Keywords

Atrial Fibrillation; Ablation

Outcome Measures

Primary Outcomes (1)

• Survival Free of Atrial Fibrillation

  Using data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as \>30 seconds.

  6 -12 months

Secondary Outcomes (1)

• Termination or Slowing of Atrial Fibrillation During Ablation

  acute

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be men and women of all races aged 21 to 80 years undergoing clinically indicated ablation of Atrial Fibrillation.

You may qualify if:

• Subjects will be patients undergoing electrophysiology study and ablation for paroxysmal or persistent atrial fibrillation (AF) after having failed \>or= 1 anti-arrhythmic drug.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of California, San Diego

La Jolla, California, 92093, United States

Location

VA San Diego Medical Center

San Diego, California, 92161, United States

Location

Related Publications (6)

• Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.

  PMID: 22818076 RESULT

• Narayan SM, Krummen DE, Rappel WJ. Clinical mapping approach to diagnose electrical rotors and focal impulse sources for human atrial fibrillation. J Cardiovasc Electrophysiol. 2012 May;23(5):447-54. doi: 10.1111/j.1540-8167.2012.02332.x. Epub 2012 Apr 26.

  PMID: 22537106 RESULT

• Narayan SM, Patel J, Mulpuru S, Krummen DE. Focal impulse and rotor modulation ablation of sustaining rotors abruptly terminates persistent atrial fibrillation to sinus rhythm with elimination on follow-up: a video case study. Heart Rhythm. 2012 Sep;9(9):1436-9. doi: 10.1016/j.hrthm.2012.03.055. Epub 2012 Mar 28. No abstract available.

  PMID: 22465458 RESULT

• Narayan SM, Krummen DE, Clopton P, Shivkumar K, Miller JM. Direct or coincidental elimination of stable rotors or focal sources may explain successful atrial fibrillation ablation: on-treatment analysis of the CONFIRM trial (Conventional ablation for AF with or without focal impulse and rotor modulation). J Am Coll Cardiol. 2013 Jul 9;62(2):138-147. doi: 10.1016/j.jacc.2013.03.021. Epub 2013 Apr 3.

  PMID: 23563126 RESULT

• Narayan SM, Shivkumar K, Krummen DE, Miller JM, Rappel WJ. Panoramic electrophysiological mapping but not electrogram morphology identifies stable sources for human atrial fibrillation: stable atrial fibrillation rotors and focal sources relate poorly to fractionated electrograms. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):58-67. doi: 10.1161/CIRCEP.111.977264. Epub 2013 Feb 7.

  PMID: 23392583 RESULT

• Narayan SM, Baykaner T, Clopton P, Schricker A, Lalani GG, Krummen DE, Shivkumar K, Miller JM. Ablation of rotor and focal sources reduces late recurrence of atrial fibrillation compared with trigger ablation alone: extended follow-up of the CONFIRM trial (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation). J Am Coll Cardiol. 2014 May 6;63(17):1761-8. doi: 10.1016/j.jacc.2014.02.543. Epub 2014 Mar 13.

  PMID: 24632280 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sanjiv Narayan (Professor of Medicine, Principal Investigator)
• Organization: University of California, San Diego

sanjiv1@stanford.edu

(650) 498-8161

Study Officials

• Sanjiv M. Narayan, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 8, 2017
• Results First Posted: February 8, 2017

Record last verified: 2016-12

Locations

US (2)