Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil

Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02835001

Acronym

HEAT-LVRC

Enrollment

Registered

2016-07-15

Start date

2019-01-15

Completion date

2019-06-15

Last updated

2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emphysema

Brief summary

Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema

Detailed description

Two sequences (around 30 minutes) are necessary by patient. Under general anesthesia, two lobs treatment ( 10 Coil by lob) successively introduced by a bronchoscope.

Interventions

PROCEDUREBronchoscopy

Two sequences of 30 minutes are necessary by patient

DEVICELung Volume Reduction Coil (HEAT-LVRC)

Bronchoscopy with Heat-LVRC

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

Inclusion criteria

* Severe emphysema (recent CT-scan (\< 6 mois) ) * Age \> 35 ans * Modified Medical Research Council Scale (mMRC) \> 2 * Forced expiratory volume in one second (FEV1) post-bronchodilatator \< 45% * Residual volume \> 175% * Total Pulmonary capacity \> 100%

Exclusion criteria

* Forced expiratory volume in one second (FEV1) variability \> 20% after bronchodilatator * Carbon Monoxide Diffusing Capacity (TLCO) \< 20% * Recurrent respiratory infection Infections with clinics symptoms * Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography \> 50 mm Hg * Impossibility to walk more that 140 meter (6 min test) * Surgery history of volume reduction or pulmonary transplantation * Broncho-dilatation with clinic symptoms

Design outcomes

Primary

Measure	Time frame	Description
Hyperinflation Assessment After Treatment	3 months	Assessed by Lung Volume Reduction Coil

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026