Congestive Heart FailureNCT01082601
Catheter Ablation for Atrial Fibrillation and Heart Failure
An observational study of Congestive Heart Failure and Atrial Fibrillation, run by St. Luke's-Roosevelt Hospital Center at 2 sites in United States.
Trial summary
To compare heart function, symptoms, exercise capacity and quality of life in patients with Congestive Heart Failure (CHF) and Atrial Fibrillation (AF)before and after catheter ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congestive Heart Failure, Atrial Fibrillation, Arrhythmia
- What is being tested?
- Pulmonary Vein Isolation (PVI)
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Jan 2012
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen in either the out patient or in hospital environment at St.Luke's-Roosevelt Hospital or The Valley Hospital, Ridgewood New Jersey, with systolic left ventricular dysfunction and atrial fibrillation. Class I-III CHF based on symptoms(shortness of breath,fatigue, peripheral edema and documented ejection fraction of less than 40%.
Who may be able to join
- Age 18 years to 80 years
- Clinical diagnosis of CHF based on symptoms (Shortness of breath, fatigue, peripheral edema)
- Systolic left ventricular dysfunction with ejection fraction 40% or less
- NYHA Class I, II or III heart failure
- Paroxysmal AF(2 or more episodes in one month) that terminate within 7 days:or persistent AF (more than 7 days or less than 7 days but terminated with pharmacologic or electrical cardioversion).
- Willing and able to sign informed consent
Who cannot join
- Previous ablation
- Left atrial size greater than 60mm(parasternal view on transthoracic echocardiogram)
- AF episodes triggered by another uniform arrhythmia(e.g.atrial flutter or atrial tachycardia)
- Active alcohol or drug abuse, which may be causative of AF
- Severe valvular disease requiring surgical repair
- Myocardial infarction within 6 months of enrollment
Show all 22Show fewer
- Abnormality that prevents catheter introduction
- Coronary surgical revascularization or other cardiac surgery within 6 months of enrollment
- Patients in whom heart transplant expected with 6 months
- AF deemed secondary to a transient or correctable cause (e.g.electrolyte imbalance ,trauma,recent surgery,,infection, toxic ingestion or endocrinopathy
- Pregnancy or women of child bearing potential \& not on reliable method of birth control
- Contraindication to Warfarin therapy or other bleeding diathesis
- Participation in another clinical trial
- Inaccessable to follow-up
- Life expectancy of less than 24 months caused by reasons other than heart disease
- Renal failure requiring dialysis
- Decompensated CHF within 48 Hours of enrollment
- Second or third degree AV block or sinus pause greater than 3 seconds, resting heart rate less 30 bpm without a permanent pacemaker
- A history of drug induced Torsades de Pointes or congenital long QT syndrome
- Currently responding to antiarrhythmic drug therapy
- Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for 24 hours or longer.
- Unwilling or unable to sign informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St.Luke's-Roosevelt Hospital
New York, New York, 10025
The Valley Hospital
Ridgewood, New Jersey, 07450
About this study
Official title: Pulmonary Vein Isolation for Rhythm Control in Patients With Atrial Fibrillation and Left Ventricular Dysfunction: A Pilot Study
To compare heart function, symptoms, exercise capacity and quality of life in patients with Congestive Heart Failure (CHF) and Atrial Fibrillation (AF)before and after catheter ablation.
Hypothesis: Restoration and maintenance of sinus rhythm by catheter ablation, without the use of antiarrhythmic drugs, in AF and CHF improves heart failure status.
- Conditions
- Congestive Heart Failure, Atrial Fibrillation, Arrhythmia
- Being tested
- Pulmonary Vein Isolation (PVI)
- Keywords
- Catheter Ablation, Atrial Fibrillation, Congestive heart failure
- Medical subject headings
- Heart Failure, Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Vein Isolation (PVI)Procedure or surgery
Also called Catheter Ablation
Subjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications.
| Study group | Role | What they receive |
|---|---|---|
| Optimal Medical therapy | Subjects with Class I,IIor III congestive heart failure on optimal medical therapy. Planned catheter ablation for paroxysmal or persistent atrial fibrillation. Paroxysmal AF defined as recurrent AF(2 or more episodes in one month) that terminate within seven days. Persistent AF defined as sustained beyond seven days, or lasting less than seven days but requiring pharmacologic or electrical cardioversion. Receives: Procedure: Pulmonary Vein Isolation (PVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in LVESV by 15% or more from baseline at 6 months
Measured: 6 months
Secondary outcomes (6)
Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram
Measured: 6 months
NYHA Class
Measured: 6 months
Quality of Life
Measured: 6 months
Six minute hall walk test
Measured: 6 months
Hospitalization for HF
Composite hospitalization for HF,thromboembolic complications, major bleeding or all cause mortality
Measured: one year
Absence of Atrial fibrillation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suneet Mittal, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082601
- Sponsor's protocol ID
- 09-137
- Status last verified
- Jun 2011
- First submitted
- 5 Mar 2010
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Isolation for Rhythm Control in Patients With Atrial Fibrillation and Left Ventricular Dysfunction: A Pilot Study
- ClinicalTrials.gov ID
- NCT01082601
- Acronym / sponsor ID
- 09-137
- Conditions
- Congestive Heart Failure, Atrial Fibrillation, Arrhythmia
- Keywords
- Catheter Ablation, Atrial Fibrillation, Congestive heart failure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Mar 2010 (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.
To compare heart function, symptoms, exercise capacity and quality of life in patients with Congestive Heart Failure (CHF) and Atrial Fibrillation (AF)before and after catheter ablation.
Hypothesis: Restoration and maintenance of sinus rhythm by catheter ablation, without the use of antiarrhythmic drugs, in AF and CHF improves heart failure status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optimal Medical therapy | – | Procedure: Pulmonary Vein Isolation (PVI)Subjects with Class I,IIor III congestive heart failure on optimal medical therapy. Planned catheter ablation for paroxysmal or persistent atrial fibrillation. Paroxysmal AF defined as recurrent AF(2 or more episodes in one month) that terminate within seven days. Persistent AF defined as sustained beyond seven days, or lasting less than seven days but requiring pharmacologic or electrical cardioversion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in either the out patient or in hospital environment at St.Luke's-Roosevelt Hospital or The Valley Hospital, Ridgewood New Jersey, with systolic left ventricular dysfunction and atrial fibrillation. Class I-III CHF based on symptoms(shortness of breath,fatigue, peripheral edema and documented ejection fraction of less than 40%.
Key inclusion criteria (6 listed)
- Age 18 years to 80 years
- Clinical diagnosis of CHF based on symptoms (Shortness of breath, fatigue, peripheral edema)
- Systolic left ventricular dysfunction with ejection fraction 40% or less
- NYHA Class I, II or III heart failure
- Paroxysmal AF(2 or more episodes in one month) that terminate within 7 days:or persistent AF (more than 7 days or less than 7 days but terminated with pharmacologic or electrical cardioversion).
Key exclusion criteria (22 listed)
- Previous ablation
- Left atrial size greater than 60mm(parasternal view on transthoracic echocardiogram)
- AF episodes triggered by another uniform arrhythmia(e.g.atrial flutter or atrial tachycardia)
- Active alcohol or drug abuse, which may be causative of AF
- Severe valvular disease requiring surgical repair
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 |
|---|---|---|
| Pulmonary Vein Isolation (PVI)Also: Catheter AblationSubjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications. | Procedure or surgery | Optimal Medical therapy |
Primary outcome
Improvement in LVESV by 15% or more from baseline at 6 months
Time frame: 6 months
6 secondary outcomes
Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram
Time frame: 6 months
NYHA Class
Time frame: 6 months
Quality of Life
Time frame: 6 months
Six minute hall walk test
Time frame: 6 months
Hospitalization for HF
Time frame: one year
Absence of Atrial fibrillation
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
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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.
Suneet Mittal, MD principal investigator
St. Luke's-Roosevelt Hospital Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Atrial Fibrillation, run by St. Luke's-Roosevelt Hospital Center at 2 sites in United States.
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 6 inclusion and 22 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: withdrawn, as of the sponsor's last update on 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement in LVESV by 15% or more from baseline at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2012.