Trial record 4 of 431 for:    Open Studies | "Atrial Fibrillation"

CatHeter Ablation of perSistEnd Atrial Fibrillation: Pulmonary Vein Isolation Versus Defragmentation. The CHASE-AF Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01580124
First received: April 16, 2012
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

Study design:

Randomized prospective comparison of pulmonary vein isolation alone versus a strategy aiming for atrial fibrillation termination by using a stepwise approach consisting of pulmonary vein isolation, biatrial defragmentation aiming for fractionated electrograms and linear ablation if required.

Study protocol:

In patients randomized to PVI alone, the index procedure consists of wide circumferential pulmonary vein isolation (1 cm distal of the PV ostium) including optional right atrial isthmus ablation. Endpoint for PVI is entrance block as evaluated by a circumferential mapping catheter during sinus rhythm at the end of the procedure. In all patients the NavX® three-dimensional mapping system should be used. The St. Jude Medical Coolflex® or Coolpath® catheters may be used at the operator's discretion.

In patients randomized to the strategy aiming for atrial fibrillation termination PVI is also the initial step of the procedure followed by atrial defragmentation and eventual linear ablation in case of atrial tachycardia aiming for acute restoration of sinus rhythm. The procedural steps with regard to mapping and ablation of atrial fibrillation and consecutive atrial tachycardia follow the previously described methods (8,9). After initial ablation the previous antiarrhythmic drug treatment can be continued but no de novo antiarrhythmic drug regiment should be applied. The primary endpoint of this study is recurrence of atrial arrhythmias between 6 and 12 months after the initial ablation procedure.

In both study arms, the same CE certified catheters will be used. Usually, the setting consists of on decapolar catheter positioned in the coronary sinus, one circumferential mapping catheters for mapping of the pulmonary veins, one quadripolar catheter for mapping the right atrium. In both study groups a externally irrigated catheter for mapping and ablation will be used (CoolFlex/ Coolpath as mentioned above).

Sample size calculation:

According to the assumption of a difference of 30 % regarding the primary endpoint (power 80, alpha=0.05) 70 patients have to be included. Considering a potential drop out of 10 % 160 patients should be included. However, an adaptive statistical plan is applied (Prof. Wegscheider, University Hospital Hamburg).

Follow up and repeat procedures:

Crossover between the two treatment options should be avoided. Previous antiarrhythmic drug treatment can be continued until month 6 after the index procedure is completed. Repeat procedures between month 0 and 3 should be avoided. Repeat procedures should be planned between month 3 and 6 after the index procedure. The initial approach of the repeat procedure is the same as during the index procedure (Figure 1). Thus, in patients randomized for PVI alone, PVI will be repeated in case of reconnection of the veins. In the setting of complete block of all pulmonary veins also patients randomized to PVI alone will receive a substrate modification as in the other group. Patients randomized to the ablation procedure aiming for AF termination will again receive a 'complete' procedure including assessment of PVI and ablation of atrial tachycardias and atrial fibrillation.

Follow-up:

All patients will be seen in the outpatient clinic every 3 month during the 12 month study period. The visit will include ECG and Holter ECG recordings. Additionally, echocardiography and interrogation of pacemaker will be performed.


Condition Intervention
Atrial Fibrillation
Catheter Ablation
Persistent Atrial Fibrillation
Pulmonary Vein Isolation
Procedure: Atrial fibrillation ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CatHeter Ablation of perSistEnd Atrial Fibrillation: Pulmonary Vein Isolation Versus Defragmentation. The CHASE-AF Study.

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

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

Secondary Outcome Measures:
  • Number of periprocedural complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PVI alone
Pulmonary vein isolation alone in persistent atrial fibrillation
Procedure: Atrial fibrillation ablation
Catheter ablation for atrial fibrillation is being investigated comparing efficacy of pulmonary vein isolation with ablation of complex fractionated electrograms and linear lesion sets
Active Comparator: PVI + Defragmentation + linear lesions
AF ablation continuation aiming for AF termination
Procedure: Atrial fibrillation ablation
Catheter ablation for atrial fibrillation is being investigated comparing efficacy of pulmonary vein isolation with ablation of complex fractionated electrograms and linear lesion sets

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Persistent atrial fibrillation > 7 days or previous cardioversion
  • Obtained written consent

Exclusion Criteria:

  • Age less than 18 years
  • Previous operative or interventional treatment of atrial fibrillation
  • Paroxysmal atrial fibrillation
  • Pregnancy
  • Contraindication for oral anticoagulation
  • Contraindication for heparin administration
  • Transient factors causing atrial fibrillation (e.g. Hyperthyroidism)
  • Drug and alcohol abuse
  • Severe underlying heart disease with left atrial enlargement > 60 mm
  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: NCT01580124

Contacts
Contact: Daniel Steven, MD +49(40)741054120

Locations
Germany
University Hospital Eppendorf Recruiting
Hamburg, Germany, 20251
Contact: Daniel Steven, MD    +40(40)7410 ext 54120    dsteven@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
St. Jude Medical
Investigators
Principal Investigator: Stephan Willems, MD University Heart Center Hamburg
Principal Investigator: Daniel Steven, MD University Heart Center Hamburg
  More Information

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01580124     History of Changes
Other Study ID Numbers: PV3572
Study First Received: April 16, 2012
Last Updated: July 20, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on July 29, 2014