PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)

Medtronic

Status and phase: Terminated; Phase 4

Conditions: Atrial Fibrillation; Heart Failure

Treatments: Procedure: Ablation; Other: Rate Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT00839566

CEN_G_CA_9

Details and patient eligibility

About

Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• LVEF <35%
• QRS time ≥150ms LBB
• NYHA classification ≥ NYHA III
• permanent (> 6 months) Atrial Fibrillation
• sinus rhythm (control group)
• Condition after Implantation of a Medtronic CRT device
• written informed consent

Exclusion criteria

• exchange of the current CRT device
• mitral incompetence (2. degree)
• no compliance
• participation in another study
• pregnancy
• patients with AV node
• patients after heart transplant or those who are on the transplant list

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

AV ablation

Experimental group

Treatment:

Procedure: Ablation

Rate control

Active Comparator group

Description:

Rate control by drugs

Treatment:

Other: Rate Control

Sinus rhythm

No Intervention group