Steward Health Care System

Return to Results

AVAIL CLS/CRT: AV-node Ablation With CLS and CRT Pacing Therapies for the Treatment of AF

new search

Trial Conditions
  • Atrial Fibrillation
  • Congestive Heart Failure
What is the purpose of this trial?

The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent pacing therapy.

Date & Status

Terminated

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Meet the indications for therapy

- Persistent, symptomatic AF with poorly controlled rapid ventricular rates or
permanent, symptomatic AF with poorly controlled rapid ventricular rates.

- Eligible for AV nodal ablation and permanent pacemaker implantation

- NYHA Class II or III heart failure

- Age ≥ 18 years

- Understand the nature of the procedure

- Ability to tolerate the surgical procedure required for implantation

- Give informed consent

- Able to complete all testing required by the clinical protocol

- Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria:

- Meet one or more of the contraindications

- Have a life expectancy of less than six months

- Expected to receive heart transplantation within six months

- Enrolled in another cardiovascular or pharmacological clinical investigation

- Patients with an ICD, or being considered for an ICD

- Patients with previously implanted biventricular pacing systems

- Patients with previously implanted single or dual chamber pacing system with > 50%
documented ventricular pacing

- Patients with previous AV node ablation

- Six-minute walk test distance greater than 450 meters

- Any condition preventing the patient from being able to perform required testing

- Presence of another life-threatening, underlying illness separate from their cardiac
disorder

- Conditions that prohibit placement of any of the lead systems

Gender: Both
Steward Physician(s)
  • Michael Orlov, MD
Facilities
  • St. Elizabeth's Medical Center - Terminated
Trial Interventions
Device
  • Protos DR/CLS and Stratos LV CRT pacemakers
Physician Researcher

Investigator Name:

  • Michael Orlov, MD

Other Information

Sponsor: Biotronik, Inc.
Phase: N/A
Trial ID: NCT00356057
Volunteers:  Not Accepting Healthy Volunteers

new search

Connect with Steward

Visit Our Twitter Feed Visit Our Facebook Page Email This Page Print This Page

Subscribe to our patient e-newsletter

Copyright © 2014 Steward Health Care
Connect Healthcare Panacea CMS Solutions