Atrial FibrillationPhase 3NCT00821353

Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

A Phase 3 study testing RF catheter ablation and Antiarrhythmic drugs in people with Atrial Fibrillation and Hypertrophic Cardiomyopathy, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Atrial Fibrillation, Hypertrophic Cardiomyopathy
What is being tested?: RF catheter ablation and Antiarrhythmic drugs
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 sitePoland
Study dates: Jan 2009to Jun 2012
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with hypertrophic cardiomyopathy and paroxysmal or chronic atrial fibrillation

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

Institute of Cardiology
Warsaw

Other trials in Poland

About this study

Official title: Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)

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.

Conditions: Atrial Fibrillation, Hypertrophic Cardiomyopathy
Being tested: RF catheter ablation, Antiarrhythmic drugs
Keywords: Atrial fibrillation, Hypertrophic cardiomyopathy, RF ablation, Antiarrhythmic drugs
Medical subject headings: Atrial Fibrillation, Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RF catheter ablationProcedure or surgery
RF catheter ablation
Antiarrhythmic drugsDrug
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF

Study groups in NCT00821353
Study group	Role	What they receive
RFCA	Active comparator	Not described Receives: Procedure: RF catheter ablation
Drug	Active comparator	Not described Receives: Drug: Antiarrhythmic drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

Changes in total symptomatic and asymptomatic AF burden.
Measured: 1 year
Incidence of complications.
Measured: 1 year
Changes in left atrial diameter and left ventricular function.
Measured: 1 year
Changes in level of Nt-pro-BNP.
Measured: 1 year
Changes in symptom severity and quality of life.
Measured: 1 year
Changes in exercise capacity assessed by cardiopulmonary exercise testing.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Jun 2012

First posted13 Jan 2009 (estimated)
Study startJan 2009
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00821353
Sponsor's protocol ID: N N402 194635
Other IDs: 1.7/IV/08
Status last verified: Feb 2013
First submitted: 11 Jan 2009
Last updated: 5 Feb 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)
ClinicalTrials.gov ID: NCT00821353
Acronym / sponsor ID: N N402 194635
Conditions: Atrial Fibrillation, Hypertrophic Cardiomyopathy
Keywords: Atrial fibrillation, Hypertrophic cardiomyopathy, RF ablation, Antiarrhythmic drugs
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (estimated)
Lead sponsor: National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
Study start: Jan 2009
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 13 Jan 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
RFCA	Active comparator	Procedure: RF catheter ablation
Drug	Active comparator	Drug: Antiarrhythmic drugs

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with hypertrophic cardiomyopathy and paroxysmal or chronic atrial fibrillation

Key exclusion criteria (12 listed)

Severe hear failure (NYHA IV)
Left ventricular ejection fraction <0.30
Left atrial diameter >65 mm
Age > 70 years
Contraindication to anticoagulation with warfarin

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RF catheter ablationRF catheter ablation	Procedure or surgery	RFCA
Antiarrhythmic drugsOne of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF	Drug	Drug

Primary outcome

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

6 secondary outcomes

Changes in total symptomatic and asymptomatic AF burden.
Time frame: 1 year
Incidence of complications.
Time frame: 1 year
Changes in left atrial diameter and left ventricular function.
Time frame: 1 year
Changes in level of Nt-pro-BNP.
Time frame: 1 year
Changes in symptom severity and quality of life.
Time frame: 1 year
Changes in exercise capacity assessed by cardiopulmonary exercise testing.
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pawel Derejko, MD, PhD principal investigator

National Institute of Cardiology, Warsaw, Poland

Lidia Chojnowska, MD, PhD principal investigator

National Institute of Cardiology, Warsaw, Poland

Lukasz Szumowski, MD, PhD principal investigator

National Institute of Cardiology, Warsaw, Poland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00821353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.