Catheter Ablation for Atrial Fibrillation and Heart Failure

NCT01082601 | Withdrawn DMC

• 1 other identifier: 09-137
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

Catheter Ablation; Atrial Fibrillation; Congestive heart failure

Outcome Measures

Primary Outcomes (1)

• Improvement in LVESV by 15% or more from baseline at 6 months

  6 months

Secondary Outcomes (6)

• Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram

  6 months

• NYHA Class

  6 months

• Quality of Life

  6 months

• Six minute hall walk test

  6 months

• Hospitalization for HF

  one year

Study Arms (1)

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.

Procedure: Pulmonary Vein Isolation (PVI)

Interventions

Pulmonary Vein Isolation (PVI) PROCEDURE

Subjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications.

Also known as: Catheter Ablation

Optimal Medical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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%.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (2)

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

St.Luke's-Roosevelt Hospital

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Suneet Mittal, MD

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 17, 2012

Record last verified: 2011-06

Locations

US (2)