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The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treatment with the IASD device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IASD | Device | IASD device implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | subjects who experience major adverse cardiac and cerebrovascular events (MACCE) defined as death, stroke, MI; or subjects who experience a systemic embolic event (excluding pulmonary thromboembolism) | 6 months |
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Key Inclusion Criteria:
Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
Age ≥ 40 years old
Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
Key Exclusion Criteria:
3. Severe heart failure defined as:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Komtebedde, DVM | Corvia Medical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Charles Hospital | Brisbane | Australia | ||||
| David Kaye |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26055211 | Background | Hasenfuss G, Gustafsson F, Kaye D, Shah SJ, Burkhoff D, Reymond MC, Komtebedde J, Hunlich M; Reduce LAP-HF Trial Investigators. Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial. J Card Fail. 2015 Jul;21(7):594-600. doi: 10.1016/j.cardfail.2015.05.008. Epub 2015 Jun 6. | |
| 27025436 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Melbourne |
| Australia |
| St. Vincent Hospital | Sydney | Australia |
| Medizinische Universität Graz | Graz | Austria |
| Allgemeines Krankenhaus Univesitäts Kliniken | Vienna | Austria |
| OLVZ Aalst | Aalst | Belgium |
| Homolka Hospital | Prague | Czechia |
| Rigshospitalet | Copenhagen | Denmark |
| CHRU de Lille | Lille | France |
| CHU de Nantes | Nantes | France |
| Hôpital Bichat | Paris | France |
| Hôpital La Pitié Salpétrière | Paris | France |
| Hôpital Rangueil | Toulouse | France |
| Universitatklinikum Duseldorf | Düsseldorf | Germany |
| Georg-August-Universitat | Göttingen | Germany |
| Asklepios Klinik St George | Hamburg | Germany |
| Cardiologicum CRC | Hamburg | Germany |
| University of Heidelberg | Heidelberg | Germany |
| Universtitaät Kliniku Schlewig Holstein | Kiel | Germany |
| Klinikum der Universität Munchen | Munich | Germany |
| St Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Auckland City Hospital | Auckland | New Zealand |
| Fourth Military Hospital | Wroclaw | Poland |
| Golden Jubilee Hospital | Glasgow | United Kingdom |
| Royal Brompton/Harefield Trust | Harefield | United Kingdom |
| King's College | London | United Kingdom |
| Hasenfuss G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016 Mar 26;387(10025):1298-304. doi: 10.1016/S0140-6736(16)00704-2. |
| 27852653 | Result | Kaye DM, Hasenfuss G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Dec;9(12):e003662. doi: 10.1161/CIRCHEARTFAILURE.116.003662. |
| 28949052 | Result | Wolsk E, Kaye D, Borlaug BA, Burkhoff D, Kitzman DW, Komtebedde J, Lam CSP, Ponikowski P, Shah SJ, Gustafsson F. Resting and exercise haemodynamics in relation to six-minute walk test in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2018 Apr;20(4):715-722. doi: 10.1002/ejhf.976. Epub 2017 Sep 26. |
| 30311437 | Result | Kaye DM, Petrie MC, McKenzie S, Hasenfubeta G, Malek F, Post M, Doughty RN, Trochu JN, Gustafsson F, Lang I, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Hausleiter J, Raake P, Jondeau G, Bergmann MW, Spelman T, Aytug H, Ponikowski P, Hayward C; REDUCE LAP-HF study investigators. Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction. ESC Heart Fail. 2019 Feb;6(1):62-69. doi: 10.1002/ehf2.12350. Epub 2018 Oct 11. |
| 30354556 | Result | Wessler J, Kaye D, Gustafsson F, Petrie MC, Hasenfubeta G, Lam CSP, Borlaug BA, Komtebedde J, Feldman T, Shah SJ, Burkhoff D; REDUCE-LAP-HF Trial Investigators and Advisors. Impact of Baseline Hemodynamics on the Effects of a Transcatheter Interatrial Shunt Device in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Aug;11(8):e004540. doi: 10.1161/CIRCHEARTFAILURE.117.004540. |
| 31653352 | Result | Hanff TC, Kaye DM, Hayward CS, Post MC, Malek F, Hasenfubeta G, Gustafsson F, Burkhoff D, Shah SJ, Litwin SE, Kahwash R, Hummel SL, Borlaug BA, Solomon SD, Lam CSP, Komtebedde J, Silvestry FE; REDUCE LAP-HF study investigators, and research staff. Assessment of Predictors of Left Atrial Volume Response to a Transcatheter InterAtrial Shunt Device (from the REDUCE LAP-HF Trial). Am J Cardiol. 2019 Dec 15;124(12):1912-1917. doi: 10.1016/j.amjcard.2019.09.019. Epub 2019 Sep 26. |
| 31753198 | Derived | Obokata M, Reddy YNV, Shah SJ, Kaye DM, Gustafsson F, Hasenfubeta G, Hoendermis E, Litwin SE, Komtebedde J, Lam C, Burkhoff D, Borlaug BA. Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Nov 26;74(21):2539-2550. doi: 10.1016/j.jacc.2019.08.1062. |