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the Study of STABLE_SR for Persistent Atrial Fibrillation (STABLE-SR)

This study is not yet open for participant recruitment.
Verified January 2013 by The First Hospital of Nanjing Medical University
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Gang Yang, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01761188
First received: December 15, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose
  • Background:the ablation outcomes for the treatment of persistent atrial fibrillation are not as satisfactory as paroxsymal AF. The successful rate ranges from 30%-55%. We found a new novel strategy for the modification of LA substrate during sinus rhythm based on our pilot study.
  • Hypothesis: our new method may be more effective than conventional strategy.
  • Objectives:The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with persistent AF:Study Group: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm ( STABLE-SR);Control Group: conventional stepwise approach for persistent AF(CPVI + Lines +CFE) .The secondary objectives of this investigation are to evaluate and compare the safety and procedural characteristics of both groups.
  • Sample size: 220
  • Time line: 2013 Q1-2014 Q2

Condition Intervention
Atrial Fibrillation
 Procedure: Ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Study of CPVI Plus Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm (STABLE-SR) for the Treatment of Persistent Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The First Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • Freedom from AF and/or atrial tachyarrhythmias (ATs) off antiarrhythmic drugs (AADs). [ Time Frame: 1 year after a single-ablation procedure ] [ Designated as safety issue: No ]
    AF and/or AT occurring in the first 3 months after the ablation (blanking period) were censored.Beyond this, any symptomatic or asymptomatic AF or AT episode that lasted for more than 30 seconds was categorized as a recurrence.


Secondary Outcome Measures:
  • total procedure time [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time from puncture to the end

  • fluoroscopy time [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    total fluoroscopy time

  • complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    occurrence of serious adverse events that included death, pericardial effusion causing tamponade or requiring pericardiocentesis, cerebrovascular events, significant PV stenosis (symptomatic or asymptomatic ≤70% reduction in PV diameter in ≥1 veins), left atrial-esophageal fistula, diaphragmatic paralysis, and any vascular complication requiring transfusion or intervention


Estimated Enrollment: 220
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STABLE-SR
CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm ( STABLE-SR)
 Procedure: Ablation
electrophysiology substrate mapping is the critical difference between both groups
Experimental: Control Group
conventional stepwise ablation approach for persistent AF(CPVI + Lines +CFE) .
 Procedure: Ablation
electrophysiology substrate mapping is the critical difference between both groups

Detailed Description:

what's is STABLE-SR approach? In our center, the LA substrate mapping was performed in patients with paroxysmal AF and persistent AF during sinus rhythm, particularly 20 normal subjects as control group as well. Our study showed that along with the duration of AF the average voltage of LA deceased and the area of low voltage zone increased. The whole activation time of entire LA would be longer. More complex fractionated electrograms was found in LA. Importantly, we identified the low voltage zone (voltage range: 0.1-0.4mV) and the transitional zone (voltage range: 0.4-1.3mV) in which most of complex fractionated electrograms located. Based on our findings a new novel ablation strategy has emerged, which is modification of LA substrate during sinus rhythm (CPVI+STABLE-SR). Our sequential protocol included 5 steps. First CPVI should be completed followed by CTI ablation to be blocked. Then if AF rhythm maintained cardioversion would be taken. High density mapping of LA substrate would be done during sinus rhythm to identify the low voltage zone and transitional zone. Linear ablation or/and spot ablation should be designed according to the mapping results. Finally bidirectional conduction block should be demonstrated for all the linear lesion and all pulmonary veins would be checked for isolation.

  Eligibility

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

Inclusion Criteria:

  • Patients undergoing a first-time ablation procedure for AF;
  • Patients with persistent or long-lasting AF; Persistent AF will be defined as a sustained episode lasting > 7 days and less than 1 years; Long-lasting persistent AF will be more than 1 year and less than 5 years.
  • Patients must be willing and able to comply with all peri-ablation and follow-up requirements.
  • Patients with atrial fibrillation will to accept the procedure of ablation.
  • Patients signed the written informed consent for the study.
  • Patients can endure the required follow up.

Exclusion Criteria:

  • Patients with paroxysmal AF; Paroxysmal AF will be defined as a sustained episode lasting < 7days.
  • Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor.
  • Patients with thromboemboli in LAA.
  • Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view).
  • Patients allergic for contrast or iodine.
  • Patients with the SCr >3.5mg/dl or Ccr < 30 ml/min
  • Patients with life expectancy < 12 months
  • Patients who are in the period of pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761188

Contacts
Contact: Minglong Chen, M.D. 008613809000791 chenminglong2001@163.com
Contact: Gang Yang, M.D. 008613520778385 yanggangpumc@yahoo.com.cn

Locations
China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University Active, not recruiting
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
The First Hospital of Nanjing Medical University
St. Jude Medical
Investigators
Principal Investigator: Minglong Chen, M.D. The First Affiliated Hospital of Nanjing Medical University
  More Information

No publications provided

Responsible Party: Gang Yang, Doctor of Cardiology Department, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01761188     History of Changes
Other Study ID Numbers: 201201
Study First Received: December 15, 2012
Last Updated: January 3, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by The First Hospital of Nanjing Medical University:
Persistent Atrial fibrillation;LA substrate;ablation;voltage mapping

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

ClinicalTrials.gov processed this record on May 22, 2013