Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China

Atrial Fibrillation Therapy: A Multi-Center Clinical Study

The mainstay of treatment for atrial fibrillation remains pharmacological;however,catheter ablation has increasingly been used over the last decades. The relative merits of each strategy have not been extensively studied. Our study was designed to determine if catheter ablation is a feasible option as first-line therapy for treating patients with symptomatic AF.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists; Procedure: catheter ablation

• Study Type: Interventional
• Enrollment (Anticipated): 1800
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Cong xin Huang, doctor; Phone Number: 13907131546; Email: huangcongxin@yahoo.com.cn
      • Principal Investigator: cong xin Huang, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1 Patients with symptomatic AF recorded by ECG or Holter 2 Age:18-75 years 3 Patients who are willing to enroll in the trial

Exclusion Criteria:

• 1 Patients accompanied hyperthyroidism 2 Patients with sever liver or renal dysfunction 3 Patients with sever cardiac dysfunction 4 Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure 5 Patients with emboli in atrium 6 Pregnant woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Antiarrythmic Drugs	Drug: Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists
Experimental: ablation	Procedure: catheter ablation; circumferential pulmonary vein isolation complex fractionated atrial electrograms ablation circumferential pulmonary vein isolation combined left atrial roof ablation circumferential pulmonary vein isolation combined left atrial isthmus ablation circumferential pulmonary vein isolation combined left atrial roof and isthmus ablation circumferential pulmonary vein isolation combined complex fractionated atrial electrograms ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with all-cause death	3 month
Number of participants with all-cause death	12 month
Number of participants with all-cause death	24 month
Number of participants with all-cause death	36 month
severe blooding complications	3 month
severe blooding complications	12 month
severe blooding complications	24 month
severe blooding complications	36 month
cardio-cerebrovascular complications	3 month
cardio-cerebrovascular complications	12 month
cardio-cerebrovascular complications	24 month
cardio-cerebrovascular complications	36 month
Number of participants with cardiovascular death events	3 month
Number of participants with cardiovascular death events	12 month
Number of participants with cardiovascular death events	24 month
Number of participants with cardiovascular death events	36 month

Secondary Outcome Measures

Outcome Measure	Time Frame
recurrence of atrial arrhythmias (AF, AFL, AT)	3 month
recurrence of atrial arrhythmias (AF, AFL, AT)	12 month
recurrence of atrial arrhythmias (AF, AFL, AT)	24 month
recurrence of atrial arrhythmias (AF, AFL, AT)	36 month
resource utilization and costs	12 month
resource utilization and costs	24 month
resource utilization and costs	36 month

Collaborators and Investigators

• Sponsor: Wuhan University
• Collaborators: West China Hospital; Guangdong Provincial People's Hospital; Shanghai Chest Hospital; Capital Medical University; Nanjing Medical University; Peking Union Medical College; Dalian Medical University
• Investigators: Study Chair: Cong xin Huang, doctor, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: April 21, 2011
• First Submitted That Met QC Criteria: April 21, 2011
• First Posted (Estimate): April 25, 2011

Study Record Updates

• Last Update Posted (Estimate): April 25, 2011
• Last Update Submitted That Met QC Criteria: April 21, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Calcium-Regulating Hormones and Agents; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Calcium; Amiodarone; Calcium Channel Blockers
• Other Study ID Numbers: CAPA001