Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2014 by Texas Cardiac Arrhythmia Research Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Monzino Hospital, Milan, Italy
Ospedale dell'Angelo, Mestre, Venice, Italy
Catholic University, Italy
University of Rome Tor Vergata
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01439386
First received: September 21, 2011
Last updated: July 31, 2014
Last verified: July 2014
  Purpose
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.

Condition Intervention Phase
Atrial Arrhythmia
Quality of Life
Procedure: Catheter ablation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Impact Of Different Ablation Approaches on Outcome In Coexistent Atrial Fibrillation and Flutter

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • Recurrence of atrial arrhythmia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in QoL score from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: September 2011
Estimated Study Completion Date: July 2016
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AF ablation with or without AFL ablation
Pulmonary vein antral isolation (PVAI)with or without cavo-tricuspid isthmus (CTI) ablation
Procedure: Catheter ablation
PVAI with or without CTI ablation
Active Comparator: AFL ablation only
Cavo-tricuspid isthmus ablation only
Procedure: Catheter ablation
CTI ablation only

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Reversible causes of atrial arrhythmia such as hyperthyroidism, pneumonia, pulmonary embolism, sarcoidosis and excessive alcohol consumption
  2. Bleeding disorder
  3. Contra-indication to anti-coagulants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439386

Locations
United States, Texas
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Monzino Hospital, Milan, Italy
Ospedale dell'Angelo, Mestre, Venice, Italy
Catholic University, Italy
University of Rome Tor Vergata
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
  More Information

Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Natale, Executive medical director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01439386     History of Changes
Other Study ID Numbers: TCAI_APPROVAL 
Study First Received: September 21, 2011
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2016