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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00821353
Other study ID # N N402 194635
Secondary ID 1.7/IV/08
Status Completed
Phase Phase 3
First received January 11, 2009
Last updated February 4, 2013
Start date January 2009
Est. completion date June 2012

Study information

Verified date February 2013
Source Institute of Cardiology, Warsaw, Poland
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial Summary

Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome.

Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients.

Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and AF.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients with hypertrophic cardiomyopathy and paroxysmal or chronic atrial fibrillation

Exclusion Criteria:

- Severe hear failure (NYHA IV)

- Left ventricular ejection fraction <0.30

- Left atrial diameter >65 mm

- Age > 70 years

- Contraindication to anticoagulation with warfarin

- Presence of a mechanical prosthetic valve

- Presence of left atrial thrombus on TEE or CT

- Woman currently pregnant

- Renal failure (GFR < 30 ml/min)

- Hepatic failure

- Untreated hypothyroidism or hyperthyroidism

- LVOT gradient > 50 mmHg

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
RF catheter ablation
RF catheter ablation
Drug:
Antiarrhythmic drugs
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF

Locations

Country Name City State
Poland Institute of Cardiology Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. 1 year No
Secondary Changes in total symptomatic and asymptomatic AF burden. 1 year No
Secondary Incidence of complications. 1 year Yes
Secondary Changes in left atrial diameter and left ventricular function. 1 year No
Secondary Changes in level of Nt-pro-BNP. 1 year No
Secondary Changes in symptom severity and quality of life. 1 year No
Secondary Changes in exercise capacity assessed by cardiopulmonary exercise testing. 1 year No
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