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The trial is taking place at:
S

South Oklahoma Heart Research, LLC | Oklahoma City, OK

Veeva-enabled site

Alleviant ALLAY-HF Study

A

Alleviant Medical

Status

Invitation-only

Conditions

Heart Failure

Treatments

Other: Sham-Control
Device: Alleviant ALV1 System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05685303
CIP-0003

Details and patient eligibility

About

Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.

Enrollment

500 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%

  2. NYHA Class II, III or ambulatory IV

  3. Exercise right heart catheterization*

    1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
    2. Exercise PVR < 1.8 WU
  4. Ongoing stable GDMT

Exclusion criteria

  1. Advanced heart failure
  2. Presence of a pacemaker
  3. Evidence of right heart dysfunction

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

500 participants in 2 patient groups

Treatment
Experimental group
Description:
Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
Treatment:
Device: Alleviant ALV1 System
Control
Sham Comparator group
Description:
Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.
Treatment:
Other: Sham-Control

Trial contacts and locations

93

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Data sourced from clinicaltrials.gov

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