NCT00821353

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for phase_3 atrial-fibrillation

Timeline
Completed

Started Jan 2009

Typical duration for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

3.4 years

First QC Date

January 11, 2009

Last Update Submit

February 4, 2013

Conditions

Atrial FibrillationHypertrophic Cardiomyopathy

Keywords

Atrial fibrillationHypertrophic cardiomyopathyRF ablationAntiarrhythmic drugs

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications.

    1 year

Secondary Outcomes (6)

  • Changes in total symptomatic and asymptomatic AF burden.

    1 year

  • Incidence of complications.

    1 year

  • Changes in left atrial diameter and left ventricular function.

    1 year

  • Changes in level of Nt-pro-BNP.

    1 year

  • Changes in symptom severity and quality of life.

    1 year

  • +1 more secondary outcomes

Study Arms (2)

RFCA

ACTIVE COMPARATOR
Procedure: RF catheter ablation

Drug

ACTIVE COMPARATOR
Drug: Antiarrhythmic drugs

Interventions

RF catheter ablationPROCEDURE

RF catheter ablation

RFCA
Antiarrhythmic drugsDRUG

One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF

Drug

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hypertrophic cardiomyopathy and paroxysmal or chronic atrial fibrillation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiology

Warsaw, Poland

Location

MeSH Terms

Conditions

Atrial FibrillationCardiomyopathy, Hypertrophic

Interventions

Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiomyopathiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Pawel Derejko, MD, PhD

    National Institute of Cardiology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

  • Lidia Chojnowska, MD, PhD

    National Institute of Cardiology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

  • Lukasz Szumowski, MD, PhD

    National Institute of Cardiology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

  • Franciszek Walczak, MD, PhD

    National Institute of Cardiology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2009

First Posted

January 13, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

PL(1)