Impact Of Different Ablation Approaches on Outcome In Coexistent Atrial Fibrillation and Flutter

NCT01439386 | Completed Phase 3

• 1 other identifier: TCAI_APPROVAL
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, multi-center, single blinded study aims to compare the influence of two different catheter ablation strategies, on long-term ablation outcome in terms of AF recurrence and quality of life (QoL) in patients presenting with coexistent AF and AFL. The two strategies to be evaluated are 1) the ablation of paroxysmal atrial fibrillation (PAF) with or without flutter (AFL) ablation (AF ± AFL) versus 2) AFL ablation alone.

Conditions

Atrial Arrhythmia; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial arrhythmia

  Any episode of AF/AT longer than 30 sec will be considered as a recurrence. Episodes that occur during the first 3 months after the procedure (blanking period) will not be considered as recurrence.

  12 months

Secondary Outcomes (1)

• Change in QoL score from baseline

  12 months

Study Arms (2)

AF ablation with or without AFL ablation

ACTIVE COMPARATOR

Pulmonary vein antral isolation (PVAI)with or without cavo-tricuspid isthmus (CTI) ablation

Procedure: Catheter ablation

AFL ablation only

ACTIVE COMPARATOR

Cavo-tricuspid isthmus ablation only

Procedure: Catheter ablation

Interventions

Catheter ablation PROCEDURE

PVAI with or without CTI ablation

AF ablation with or without AFL ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18years
• Patients presenting with paroxysmal AF and typical AFL
• Ability to provide written, informed consent

You may not qualify if:

• Reversible causes of atrial arrhythmia such as hyperthyroidism, pneumonia, pulmonary embolism, sarcoidosis and excessive alcohol consumption
• Bleeding disorder
• Contra-indication to anti-coagulants

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead
• Monzino Hospital, Milan, Italy: collaborator
• Ospedale dell'Angelo, Venezia-Mestre: collaborator
• Catholic University, Italy: collaborator
• University of Rome Tor Vergata: collaborator

Study Sites (1)

Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Austin, Texas, 78705, United States

Location

Related Publications (2)

• References: Symptomatic improvement after radiofrequency catheter ablation for typical atrial flutter; Heart 2001;86:167-171 Quality-of-Life in Patients With Paroxysmal Atrial Fibrillation After Catheter Ablation: Results of Long-Term Follow-Up; PACE 2003; 26:678-684 Quality of life restored to normal in patients with atrial fibrillation after pulmonary vein ostial Isolation; Am Heart J 2004;148:318-25 Effect of Left Atrial Ablation on the Quality of Life in Patients With Atrial Fibrillation; Circ J 2008; 72: 582-587 Catheter Ablation for Atrial Fibrillation in Congestive Heart Failure; N Engl J Med 2004;351:2373-83. Effects of Radiofrequency Catheter Ablation on Quality of Life in Patients With Atrial Flutter; Am J Cardiol 1999;84:278-283 Radiofrequency Catheter Ablation of Common Atrial Flutter : Significance of Palpitations and Quality-of-Life Evaluation in Patients With Proven Isthmus Block; Circulation 1999;99;534-540 Relationship Between Atrial Fibrillation and Typical Atrial Flutter in Humans; Circulation. 1997;96:3484-3491 Combining ablation of atrial fibrillation with ablation of atrial flutter: Are we there yet? JACC, Vol 43, No. 11, 2004 Factors predicting recurrences of atrial fibrillation after radiofrequency catheter ablation of typical atrial flutter; Seminars in Cardiology, 2003, vol. 9, No. 3: 55-60 Effectiveness of catheter ablation for coexisting atrial fibrillation and atrial flutter; Am J Cardiol 2004; 94:666-668 Quality of Life in Atrial Fibrillation: Measurement Tools and Impact of Interventions; J Cardiovasc Electrophysiol. 2008 July ; 19(7): 762-768 Clinical significance of inducible atrial flutter during pulmonary vein isolation in patients with atrial fibrillation. J Am Coll Cardiol. 2004 Jun 2;43(11):2057-62. Effectiveness of catheter ablation for coexisting atrial fibrillation and atrial flutter. Am J Cardiol. 2004 Sep 1;94(5):666-8.

  RESULT

• Mohanty S, Mohanty P, Di Biase L, Bai R, Santangeli P, Casella M, Dello Russo A, Tondo C, Themistoclakis S, Raviele A, Rossillo A, Corrado A, Pelargonio G, Forleo G, Natale A. Results from a single-blind, randomized study comparing the impact of different ablation approaches on long-term procedure outcome in coexistent atrial fibrillation and flutter (APPROVAL). Circulation. 2013 May 7;127(18):1853-60. doi: 10.1161/CIRCULATIONAHA.113.001855. Epub 2013 Apr 9.

  PMID: 23572499 DERIVED

MeSH Terms

Interventions

Catheter Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive medical director

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 23, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2016
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

US (1)